Video Abstract
Recently, the Neonatal Resuscitation Program (NRP) recommended against routine endotracheal suctioning of meconium-stained nonvigorous newborns but suggested resuscitation with positive pressure ventilation. Our purpose is to study the effects of this change in management.
In this multicenter cohort study, we compare 130 nonvigorous newborns born during the retrospective 1-year period before the implementation of new NRP guidelines (October 1, 2015, to September 30, 2016) to 101 infants born during the 1-year prospective period after implementation (October 1, 2016, to September 30, 2017).
Endotracheal suctioning was performed predominantly in the retrospective group compared with the prospective group (70% vs 2%), indicating the change in practice. A significantly higher proportion of newborns were admitted to the NICU for respiratory issues in the prospective group compared with the retrospective group (40% vs 22%) with an odds ratio (OR) of 2.2 (95% confidence interval [CI]: 1.2–3.9). Similarly, a significantly higher proportion of infants needed oxygen therapy (37% vs 19%) with an OR of 2.5 (95% CI: 1.2–4.5), mechanical ventilation (19% vs 9%) with an OR of 2.6 (95% CI: 1.1–5.8), and surfactant therapy (10% vs 2%) with an OR of 5.8 (95% CI: 1.5–21.8). There were no differences in the incidence of other outcomes, including meconium aspiration syndrome.
The recent NRP guideline change was not associated with an increased incidence of meconium aspiration syndrome but was associated with an increased incidence of NICU admissions for respiratory issues. Also, the need for mechanical ventilation, oxygen, and surfactant therapy increased.
The Neonatal Resuscitation Program’s seventh edition recommended against routine endotracheal suctioning of newborns who are nonvigorous and meconium stained. There are concerns regarding the safety and efficacy of this change in practice because it is not based on large randomized controlled trials.
Having no routine endotracheal suctioning of newborns who are nonvigorous and meconium stained was not associated with an increased incidence of meconium aspiration syndrome, but it was associated with an increased incidence of NICU respiratory admissions. Also, the need for mechanical ventilation, oxygen, and surfactant therapy increased.
Meconium-stained amniotic fluid (MSAF) is a major perinatal clinical concern, which occurs in 8% to 15% of all deliveries. Out of the infants born through MSAF, 10% to 20% are nonvigorous and 3% to 5% develop meconium aspiration syndrome (MAS).1,2 Modern obstetric practices, such as the avoidance of postmaturity, may have for the most part contributed to the reduction in the incidence of MAS.3,4 Over the years, the Neonatal Resuscitation Program (NRP) has been recommending less aggressive interventions for newborns who are meconium stained after published evidence from large randomized controlled trials.5,–7 Until recently, nonvigorous newborns born through MSAF were routinely intubated and suctioned below the vocal cords to prevent perinatal aspiration of meconium.8,–10 This recommendation was based on and supported by researchers in several observational studies.11,–14 The NRP’s seventh edition suggested against routine endotracheal suctioning but recommended resuscitation of these depressed newborns with positive pressure ventilation (PPV) to minimize the delay in initiating ventilation.15 Because this recommendation of not routinely performing endotracheal suctioning in newborns who are nonvigorous and meconium stained is, unlike previous guideline changes, not based on large randomized controlled trials performed in the developed world, there are concerns regarding the safety and efficacy of this delivery room practice change.
Our neonatal practice covering 4 delivery services in Baylor Scott & White Health North Texas adopted seventh edition NRP guidelines starting October 1, 2016. Our objective in this study is to report the effects of this delivery room management change on newborns who are nonvigorous born through MSAF. We hypothesized that the current guidelines are safe and not associated with an increased incidence of MAS.
Methods
Management of Newborns Who Are Nonvigorous and Meconium Stained
Before October 1, 2016, our practice was routine intubation and endotracheal suctioning of the newborns who are nonvigorous, meconium stained, and born with depressed breathing, decreased tone, and/or a heart rate of <100 beats per minute. The resuscitation provider skilled in the procedure performed intubation and endotracheal suctioning for ∼3 to 5 seconds using a meconium aspirator before the newborn took multiple breaths. If no meconium was recovered, no further suctioning was performed. If meconium was recovered, intubation and endotracheal suctioning were repeated, provided there was no significant bradycardia. If the heart rate was <100 beats per minute, PPV was provided to the newborn with the appropriate device. Starting October 1, 2016, the practice was changed to not routinely perform endotracheal suctioning but provide PPV if the newborn who was meconium stained and nonvigorous remained apneic or bradycardic after the initial steps of resuscitation were completed. This included oronasopharyngeal suctioning with a bulb or DeLee catheter if needed. Endotracheal suctioning was reserved only for those depressed newborns with evidence of meconium obstructing the airway. Obstetricians did not perform intrapartum oronasopharyngeal suctioning before the delivery of shoulders during both study periods. Cord clamping was not delayed during both study periods.
Data Collection
With approval from the local institutional review board, our data were extracted from medical records of mothers and nonvigorous newborns born through MSAF. Deliveries of <35 weeks were excluded because those newborns were directly admitted to the NICU per hospital policy. The retrospective study period was 1 year, from October 1, 2015, to September 30, 2016. The prospective study period was also 1 year, from October 1, 2016, to September 30, 2017. Collected data included maternal demographics, obstetric and fetal complications, mode of delivery, and meconium consistency. Fetal distress diagnosis was based on fetal heart rate tracings (category II and III).16 Meconium was classified as thick if the fluid was of pea soup consistency or opaque and containing particulate material. Neonatal data included gestational age, birth weight, sex, Apgar scores, and other resuscitation variables. Respiratory outcome data included admissions to the NICU, transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), pneumothorax, MAS, and hypoxic-ischemic encephalopathy (HIE). The diagnosis of TTN was made if there was a delay in the clearance of lung fluid.17 The diagnosis of RDS was based on a requirement of supplemental oxygen to maintain a Pao2 level of >50 mm Hg or a requirement of supplemental oxygen to maintain a pulse oximeter saturation of >85% within the first 24 hours of life and a chest radiograph consistent with a reticulogranular appearance to the lung fields with or without low lung volumes and air bronchograms within the first 24 hours of life. Pneumothorax was diagnosed if the infant had extrapleural air diagnosed via a chest radiograph or thoracentesis.18 MAS was diagnosed in infants born via MSAF with poor lung compliance and hypoxemia clinically, patchy opacification and hyperinflation radiographically, and in infants whose symptoms could not be otherwise explained.19 The diagnosis of pulmonary hypertension was made via an echocardiogram with findings of tricuspid regurgitation, deviation of interventricular septum to the left, and/or the presence of a right to left shunt at the patent foramen ovale and patent ductus arteriosus.20 The diagnosis of HIE was based on metabolic acidosis with a cord pH of <7 or a base deficit of ≥12 mmol/L, an early onset of encephalopathy, and/or multisystem organ dysfunction.21 The need for oxygen, mechanical ventilation (including high frequency), surfactant, inhaled nitric oxide, or hypothermia therapy was documented. Transfers to a higher level of care for extracorporeal membrane oxygenation (ECMO) or home oxygen therapy were reported. Hospital durations of oxygen therapy, mechanical ventilation, and NICU length of stay were collected.
Data Analysis
For the purpose of this pre- and postintervention cohort study in which we compared 2 different study periods, a convenience sample size of 100 newborns who were nonvigorous and born through MSAF in each arm was deemed appropriate on the basis of previous studies.22,23 This sample size was feasible with a 1-year study period for each arm. Continuous data are presented as mean and SD if they are parametrically distributed or median and 25th to 75th interquartile range if they are nonparametric; other variables are presented as counts (percent). Data were compared between the retrospective and prospective cohorts with the use of the 2-tailed Student’s t test or Mann–Whitney U test for continuous variables and Pearson’s χ2 test or Fisher’s exact test for categorical variables. Logistic regression was used to assess the association between major outcomes and changes in delivery room management. The results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). Data are analyzed by using IBM SPSS version 25 (IBM Corporation, Armonk, NY). Statistical significance is set at a probability value of <.05.
Results
During the retrospective time period, a total of 11 163 mothers delivered at ≥35 weeks’ gestation. MSAF was noted in 1303 (12%) deliveries, yielding 130 (10%) newborns who were nonvigorous. During the prospective time period, a total of 10 717 mothers delivered at ≥35 weeks’ gestation. MSAF was noted in 1282 (12%) deliveries, yielding 101 (8%) newborns who were nonvigorous. Maternal characteristics were similar between the retrospective and prospective groups (Table 1). There were no differences in the modes of delivery, incidences of intrauterine growth restriction, oligohydramnios, chorioamnionitis, placental abruption, or shoulder dystocia. The deliveries associated with fetal distress were significantly higher in the prospective group compared with the retrospective group (57% vs 43%).
Maternal Characteristics
| . | Retrospective (N = 130) . | Prospective (N = 101) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Maternal age, ya | 29.1 ± 6.1 | 28.0 ± 5.6 | .16 |
| Maternal race | .64 | ||
| White | 91 (70) | 65 (64) | |
| African American | 27 (21) | 24 (24) | |
| Other | 12 (9) | 12 (12) | |
| Hypertensive disorders of pregnancy | 28 (22) | 25 (25) | .64 |
| Maternal diabetes | 7 (5) | 6 (6) | .86 |
| Intrauterine growth restriction | 2 (2) | 5 (5) | .13 |
| Oligohydramnios | 7 (5) | 4 (4) | .61 |
| Group B Streptococcus-positive | 34 (26) | 28 (28) | .79 |
| Chorioamnionitis | 25 (19) | 22 (22) | .63 |
| Rupture of membranes ≥18 h | 24 (19) | 30 (30) | .05 |
| Placental abruption | 6 (5) | 1 (1) | .11 |
| Fetal distress | 56 (43) | 58 (57) | .03 |
| Vaginal delivery | 74 (57) | 59 (58) | .82 |
| Assisted | 10 (14) | 7 (12) | .78 |
| Cesarean delivery | 56 (43) | 42 (42) | .88 |
| Emergency | 10 (18) | 10 (24) | .53 |
| Thick meconium | 66 (51) | 61 (60) | .15 |
| Shoulder dystocia | 9 (7) | 3 (3) | .12 |
| . | Retrospective (N = 130) . | Prospective (N = 101) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Maternal age, ya | 29.1 ± 6.1 | 28.0 ± 5.6 | .16 |
| Maternal race | .64 | ||
| White | 91 (70) | 65 (64) | |
| African American | 27 (21) | 24 (24) | |
| Other | 12 (9) | 12 (12) | |
| Hypertensive disorders of pregnancy | 28 (22) | 25 (25) | .64 |
| Maternal diabetes | 7 (5) | 6 (6) | .86 |
| Intrauterine growth restriction | 2 (2) | 5 (5) | .13 |
| Oligohydramnios | 7 (5) | 4 (4) | .61 |
| Group B Streptococcus-positive | 34 (26) | 28 (28) | .79 |
| Chorioamnionitis | 25 (19) | 22 (22) | .63 |
| Rupture of membranes ≥18 h | 24 (19) | 30 (30) | .05 |
| Placental abruption | 6 (5) | 1 (1) | .11 |
| Fetal distress | 56 (43) | 58 (57) | .03 |
| Vaginal delivery | 74 (57) | 59 (58) | .82 |
| Assisted | 10 (14) | 7 (12) | .78 |
| Cesarean delivery | 56 (43) | 42 (42) | .88 |
| Emergency | 10 (18) | 10 (24) | .53 |
| Thick meconium | 66 (51) | 61 (60) | .15 |
| Shoulder dystocia | 9 (7) | 3 (3) | .12 |
Data are given as mean ± SD.
Newborn characteristics such as gestational age, birth weight, and sex were similar between the retrospective and prospective groups (Table 2). The proportion of infants born late preterm (35 to <37 weeks’ gestation) or postterm (>42 weeks’ gestation) was significantly higher in the prospective group compared with the retrospective group (12% vs 2%). The proportion of newborns with 1-minute Apgar scores of <3 and/or 5-minute Apgar scores of <7 were similar between groups. Endotracheal suctioning was performed predominantly in the retrospective group (70% vs 2%) and mask PPV primarily in the prospective group (55% vs 19%), indicating the change in practice.
Newborn Characteristics
| . | Retrospective (N = 130) . | Prospective (N = 101) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Gestational age, wka | 39.9 ± 1.1 | 39.9 ± 1.5 | .99 |
| Birth weight, gramsa | 3453.7 ± 549 | 3397.5 ± 620 | .47 |
| Boy | 64 (49) | 62 (61) | .07 |
| Late preterm | 1 (1) | 6 (6) | .02 |
| Postterm | 1 (1) | 6 (6) | .02 |
| Small for gestation | 14 (11) | 12 (12) | .79 |
| Large for gestation | 14 (11) | 8 (8) | .46 |
| Apgar score, nb, min | |||
| 1 | 4 (0–7) | 4 (0–7) | .85 |
| 5 | 8 (0–9) | 8 (0–9) | .10 |
| 1-min Apgar score <3 | 32 (25) | 21 (21) | .59 |
| 5-min Apgar score <7 | 23 (18) | 22 (22) | .50 |
| PPV | 24 (19) | 55 (55) | <.01 |
| Endotracheal suctioning | 91 (70) | 2 (2) | <.01 |
| Meconium recovered | 44 (48) | 2 (100) | .15 |
| Cardiopulmonary resuscitation | 1 (1) | 2 (2) | .42 |
| . | Retrospective (N = 130) . | Prospective (N = 101) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Gestational age, wka | 39.9 ± 1.1 | 39.9 ± 1.5 | .99 |
| Birth weight, gramsa | 3453.7 ± 549 | 3397.5 ± 620 | .47 |
| Boy | 64 (49) | 62 (61) | .07 |
| Late preterm | 1 (1) | 6 (6) | .02 |
| Postterm | 1 (1) | 6 (6) | .02 |
| Small for gestation | 14 (11) | 12 (12) | .79 |
| Large for gestation | 14 (11) | 8 (8) | .46 |
| Apgar score, nb, min | |||
| 1 | 4 (0–7) | 4 (0–7) | .85 |
| 5 | 8 (0–9) | 8 (0–9) | .10 |
| 1-min Apgar score <3 | 32 (25) | 21 (21) | .59 |
| 5-min Apgar score <7 | 23 (18) | 22 (22) | .50 |
| PPV | 24 (19) | 55 (55) | <.01 |
| Endotracheal suctioning | 91 (70) | 2 (2) | <.01 |
| Meconium recovered | 44 (48) | 2 (100) | .15 |
| Cardiopulmonary resuscitation | 1 (1) | 2 (2) | .42 |
Data are given as mean ± SD.
Data are given as median (interquartile range).
After adjusting for late preterm, postterm, and deliveries with fetal distress, a significantly higher proportion of infants were admitted to the NICU for respiratory issues (distress or failure) in the prospective group compared with the retrospective group (40% vs 22%) with an OR of 2.2 (95% CI: 1.2–3.9). Similarly, a significantly higher proportion of infants needed oxygen therapy (37% vs 19%) with an OR of 2.5 (95% CI: 1.2–4.5), mechanical ventilation (19% vs 9%) with an OR of 2.6 (95% CI: 1.1–5.8), and surfactant therapy (10% vs 2%) with an OR of 5.8 (95% CI: 1.5–21.8). There were no differences in the incidences of other outcomes, including MAS or HIE (Table 3). Death or positive results for sepsis culture including pneumonia did not occur in either group. Among NICU admissions, the incidences of MAS, HIE, and other respiratory morbidities were similar between groups with a median NICU length of stay of 6 days (Table 4). Similarly, the incidence of therapy and outcomes among infants diagnosed with MAS did not differ significantly between groups (Table 5).
Neonatal Therapy and Outcomes
| . | Retrospective (N = 130) . | Prospective (N = 101) . | OR (95% CI)a . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| NICU respiratory admissionsb | 29 (22) | 40 (40) | 2.2 (1.2–3.9) |
| Oxygen therapyb | 24 (19) | 37 (37) | 2.5 (1.2–4.5) |
| Mechanical ventilationb | 11 (9) | 19 (19) | 2.6 (1.1–5.8) |
| Surfactant therapyb | 3 (2) | 10 (10) | 5.8 (1.5–21.8) |
| Inhaled nitric oxide therapy | 3 (2) | 6 (6) | 2.9 (0.71–12) |
| Hypothermia therapy | 4 (3) | 5 (5) | 1.8 (0.55–5.4) |
| MAS | 7 (5) | 11 (11) | 2.3 (0.83–6.2) |
| HIE | 5 (4) | 6 (6) | 1.4 (0.39–4.9) |
| Transfer for ECMO | 2 (2) | 1 (1) | 0.69 (0.06–7.8) |
| . | Retrospective (N = 130) . | Prospective (N = 101) . | OR (95% CI)a . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| NICU respiratory admissionsb | 29 (22) | 40 (40) | 2.2 (1.2–3.9) |
| Oxygen therapyb | 24 (19) | 37 (37) | 2.5 (1.2–4.5) |
| Mechanical ventilationb | 11 (9) | 19 (19) | 2.6 (1.1–5.8) |
| Surfactant therapyb | 3 (2) | 10 (10) | 5.8 (1.5–21.8) |
| Inhaled nitric oxide therapy | 3 (2) | 6 (6) | 2.9 (0.71–12) |
| Hypothermia therapy | 4 (3) | 5 (5) | 1.8 (0.55–5.4) |
| MAS | 7 (5) | 11 (11) | 2.3 (0.83–6.2) |
| HIE | 5 (4) | 6 (6) | 1.4 (0.39–4.9) |
| Transfer for ECMO | 2 (2) | 1 (1) | 0.69 (0.06–7.8) |
Adjusted for late preterm, postterm, and deliveries with fetal distress.
P < .05.
Therapy and Outcomes Among NICU Admissions
| . | Retrospective (N = 29) . | Prospective (N = 40) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Oxygen therapy | 24 (83) | 37 (93) | .27 |
| Duration of oxygen therapy, da,b | 4.4 ± 4.6 | 6.4 ± 6.8 | .18 |
| 3 (0–18) | 5 (0–28) | ||
| Mechanical ventilation | 11 (38) | 19 (48) | .43 |
| Duration of mechanical ventilation, da,b | 1.3 ± 2.6 | 2.1 ± 3.9 | .37 |
| 0 (0–10) | 0 (0–17) | ||
| Surfactant therapy | 3 (10) | 10 (25) | .12 |
| Inhaled nitric oxide therapy | 3 (10) | 6 (15) | .57 |
| Hypothermia therapy | 4 (14) | 5(13) | .89 |
| TTN | 17 (59) | 21 (53) | .75 |
| RDS | 0 (0) | 2(5) | .22 |
| Pneumothorax | 3 (10) | 5 (13) | .78 |
| MAS | 7 (24) | 11 (28) | .75 |
| Pulmonary hypertension | 3 (10) | 6 (15) | .57 |
| HIE | 5 (17) | 6 (15) | .80 |
| Discharged from the hospital on oxygenc | 0 (0) | 1 (3) | .39 |
| Length of stay, da,b | 7.7 ± 6.3 | 9.1 ± 11.0 | .56 |
| 6 (2–27) | 6 (1–52) | ||
| Transfer for ECMO | 2 (7) | 1 (3) | .38 |
| . | Retrospective (N = 29) . | Prospective (N = 40) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Oxygen therapy | 24 (83) | 37 (93) | .27 |
| Duration of oxygen therapy, da,b | 4.4 ± 4.6 | 6.4 ± 6.8 | .18 |
| 3 (0–18) | 5 (0–28) | ||
| Mechanical ventilation | 11 (38) | 19 (48) | .43 |
| Duration of mechanical ventilation, da,b | 1.3 ± 2.6 | 2.1 ± 3.9 | .37 |
| 0 (0–10) | 0 (0–17) | ||
| Surfactant therapy | 3 (10) | 10 (25) | .12 |
| Inhaled nitric oxide therapy | 3 (10) | 6 (15) | .57 |
| Hypothermia therapy | 4 (14) | 5(13) | .89 |
| TTN | 17 (59) | 21 (53) | .75 |
| RDS | 0 (0) | 2(5) | .22 |
| Pneumothorax | 3 (10) | 5 (13) | .78 |
| MAS | 7 (24) | 11 (28) | .75 |
| Pulmonary hypertension | 3 (10) | 6 (15) | .57 |
| HIE | 5 (17) | 6 (15) | .80 |
| Discharged from the hospital on oxygenc | 0 (0) | 1 (3) | .39 |
| Length of stay, da,b | 7.7 ± 6.3 | 9.1 ± 11.0 | .56 |
| 6 (2–27) | 6 (1–52) | ||
| Transfer for ECMO | 2 (7) | 1 (3) | .38 |
Data are given as mean ± SD.
Data are given as median (interquartile range).
Sample size corrected for infants transferred out.
Therapy and Outcomes Among Infants Diagnosed With MAS
| . | Retrospective (N = 7) . | Prospective (N = 11) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Duration of oxygen therapy, da,b | 6.8 ± 4.6 | 13.3 ± 8.8 | .15 |
| 5 (2–13) | 11 (4–28) | ||
| Mechanical ventilation | 6 (86) | 10 (91) | .10 |
| Duration of mechanical ventilation, da,b | 1.4 ± 1.1 | 5.5 ± 6.0 | .16 |
| 1 (0–3) | 3 (0–17) | ||
| Surfactant therapy | 3 (43) | 8 (73) | .33 |
| Inhaled nitric oxide therapy | 2 (29) | 5 (46) | .64 |
| Hypothermia therapy | 0 (0) | 1 (9) | >.99 |
| Pneumothorax | 0 (0) | 1 (9) | >.99 |
| Pulmonary hypertension | 2 (29) | 5 (46) | .64 |
| HIE | 0 (0) | 1 (9) | >.99 |
| Discharged from the hospital on oxygenc | 0 (0) | 1 (10) | >.99 |
| Length of stay, da,b | 7.8 ± 4.4 | 18.8 ± 19.2 | .24 |
| 6 (4–15) | 9 (5–52) | ||
| Transfer for ECMO | 2 (29) | 1 (9) | .53 |
| . | Retrospective (N = 7) . | Prospective (N = 11) . | P . |
|---|---|---|---|
| n (%) . | n (%) . | ||
| Duration of oxygen therapy, da,b | 6.8 ± 4.6 | 13.3 ± 8.8 | .15 |
| 5 (2–13) | 11 (4–28) | ||
| Mechanical ventilation | 6 (86) | 10 (91) | .10 |
| Duration of mechanical ventilation, da,b | 1.4 ± 1.1 | 5.5 ± 6.0 | .16 |
| 1 (0–3) | 3 (0–17) | ||
| Surfactant therapy | 3 (43) | 8 (73) | .33 |
| Inhaled nitric oxide therapy | 2 (29) | 5 (46) | .64 |
| Hypothermia therapy | 0 (0) | 1 (9) | >.99 |
| Pneumothorax | 0 (0) | 1 (9) | >.99 |
| Pulmonary hypertension | 2 (29) | 5 (46) | .64 |
| HIE | 0 (0) | 1 (9) | >.99 |
| Discharged from the hospital on oxygenc | 0 (0) | 1 (10) | >.99 |
| Length of stay, da,b | 7.8 ± 4.4 | 18.8 ± 19.2 | .24 |
| 6 (4–15) | 9 (5–52) | ||
| Transfer for ECMO | 2 (29) | 1 (9) | .53 |
Data are given as mean ± SD.
Data are given as median (interquartile range).
Sample size corrected for infants transferred out.
Discussion
Our large newborn practice always has a resuscitation provider proficient in intubation to attend deliveries associated with MSAF. Although there was no concern for not providing timely ventilation for these newborns who were depressed and meconium stained, we embraced the recommendations suggested by the NRP’s seventh edition and monitored the effects of the change. In this cohort study conducted in the developed world setting of a lower incidence of mortality and MAS, we present observations made before and after the change in NRP guidelines in a large group of newborns who were meconium stained and nonvigorous. The change in practice was evident from a significantly higher incidence of endotracheal suctioning in the retrospective group and the application of PPV primarily in the prospective group. The increased NICU respiratory admissions in the prospective group prompt questions of the safety and efficacy of having no routine endotracheal suctioning of newborns who were meconium stained and depressed. Although there was no difference in the incidence of MAS, significantly higher proportions of infants needing mechanical ventilation, oxygen, and surfactant therapy may indicate increased respiratory morbidity in the prospective group.
Intubation is an invasive and stressful procedure with lower Apgar scores and airway complications previously reported in infants who were vigorous and meconium stained.5,24 Despite avoiding delivery room intubation in the majority of newborns who were nonvigorous and meconium stained in the prospective group of the current study, the proportions of newborns with 1-minute Apgar scores of <3 and/or 5-minute Apgar scores of <7 were similar to the retrospective group in which the majority of newborns were routinely intubated and suctioned. This may indicate that intubation of the newborns who were depressed and nonvigorous is not associated with the same delivery room complications seen in active vigorous newborns born via MSAF. Speculating the reasoning for significant increases in NICU respiratory admissions is beyond the scope of this study, but not clearing the meconium from proximal airways in a few cases may have contributed to increased respiratory morbidity. MAS is a complex disease associated with long-term neurodevelopmental morbidity.25 In this study, although therapy and outcomes were similar among infants diagnosed with MAS, the increased durations of oxygen therapy, mechanical ventilation, and NICU lengths of stay in the prospective group may indicate increased severity. The NRP’s seventh edition clearly states that no routine endotracheal suctioning is a guideline and not a strict recommendation. However, it is not entirely clear which of the nonvigorous newborns need endotracheal suctioning for meconium obstruction. Following these recent NRP guidelines in our practice, fewer infants than needed might have had endotracheal suctioning performed. Approximately half (48%) of the nonvigorous newborns with endotracheal suctioning had meconium recovered in the retrospective group, whereas only 2% had endotracheal suctioning performed in the prospective group for obstructed airways.
In comparing previous and recent NRP guidelines managing newborns who were meconium stained and nonvigorous in the delivery room, this large multicenter cohort study has several limitations. The significant differences between both groups with regard to deliveries with fetal distress and late preterm or postterm births are a major weakness of this pre- and postintervention cohort study in which we report observational data during different study periods. However, the groups’ differences were adjusted for the major outcomes. There were infants in the retrospective group who received PPV (19%) and infants in the prospective group who had endotracheal suctioning performed (2%). We analyzed them in the study period in which they were born for unbiased estimates of the effects of the guideline change. There was a risk of creating prognostic differences between the groups if we excluded those infants. A confounding of the results by other changes in practice is also a risk of this study design. However, our practice did not change much other than the use of electrocardiography for estimations of heart rate in the event of a prolonged resuscitation in the delivery room. Our practice of having equally skilled resuscitation providers proficient in intubation might not represent every other delivery room setting. Despite these limitations, we believe this study contributes to observations addressing an important consternation of the delivery room care of newborns who are meconium stained and nonvigorous.
Although done on the basis of anecdotal evidence, over the decades the newborns who were nonvigorous and born through MSAF were routinely intubated and suctioned to prevent perinatal aspiration of meconium.2 With the recent guideline change of no routine endotracheal suctioning, the NRP placed a greater value on avoiding harm caused by delaying the initiation of ventilation.15 This change in delivery room management of newborns who are meconium stained and nonvigorous is based on the nonavailability of sufficient evidence to continue recommending routine endotracheal suctioning and underpowered randomized clinical trials failing to show any benefit.22,23 However, the authors of these trials acknowledge the need for larger studies to validate the findings. Moreover, generalizability of these results was questioned because of relatively high incidences of mortality and MAS in these studies.26 Performing a large randomized controlled trial in newborns who are nonvigorous and meconium stained may be ethically and logistically challenging,27 but we provide enough evidence for the need to conduct larger studies.
Conclusions
The recent NRP guideline change in the delivery room management of newborns who are nonvigorous and born through MSAF avoided a large number of intubations in the delivery room and was not associated with an increased incidence of MAS. However, this change was associated with a higher incidence of NICU respiratory admissions and increased needs for mechanical ventilation, oxygen, and surfactant therapy. Additional large randomized controlled trials are needed to look into the safety and efficacy of this practice change.
- CI
confidence interval
- ECMO
extracorporeal membrane oxygenation
- HIE
hypoxic-ischemic encephalopathy
- MAS
meconium aspiration syndrome
- MSAF
meconium-stained amniotic fluid
- NRP
Neonatal Resuscitation Program
- OR
odds ratio
- PPV
positive pressure ventilation
- RDS
respiratory distress syndrome
- TTN
transient tachypnea of the newborn
Dr Chiruvolu conceptualized and designed the study, designed the data collection instruments, collected and analyzed the data, drafted the initial manuscript, and reviewed and revised the manuscript; Ms Miklis and Ms Chen designed the data collection instruments, collected data, and critically reviewed the manuscript for important intellectual content; Ms Petrey coordinated data collection and critically reviewed the manuscript for important intellectual content; Dr Desai conducted the statistical analyses, drafted tables, and critically reviewed the manuscript for important intellectual content; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
FUNDING: No external funding.
COMPANION PAPER: A companion to this article can be found online at www.pediatrics.org/cgi/doi/10.1542/peds.2018-3052.
References
Competing Interests
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
This present article confirms our daily practice of primary responders that the resuscitation guidelines are not up to date with clinical practice. Wait and watch doesnt work well in practice. The guidelines are designed as a tool for everybody to understand the first steps in resuscitation until they acquire enough skills to maneuver the ship through the storm safely.
Telling a beginner in resuscitation not to do something is better than doing something is fatal. What the beginner hears is "DONT GIVE OXYGEN", "DONT SUCTION", "DONT....", just stand by and watch. This Wait and Watch approach has to change and it has to change asap.
As an instructor in Neonatal resuscitation, I am amazed by the effect that those guidelines have on listeners who hear them for the first time. It's a good attempt but they are not fit for the audience.
There must be a difference in teaching between professionals and beginners.
The guidelines cannot be designed with the motto of one size fits all. The professional primary responder can decide what to do in each minute during resuscitation having spent many years in the newborn intensive care unit. Everyone who understands the pathophysiology during resuscitation knows that Oxygen and Ventilation are the driving forces and the only true measures to rescue a baby. To leave suction away completely in a nonvigorous newborn with or without meconium is the wrong approach. Oxygen and ventilation have to reach the patient sometimes faster than other times. A very important link that is missing in the guidelines is that the guidelines can not predict or estimate the amount of asphyxia.
You don't want to wait for a couple of minutes until you start giving oxygen with PPV or suction in a very asphyctic newborn. A professional in daily practice starts oxygen with PPV right away if necessary or suctions. A beginner will wait according to the new and old guidelines. The beginner waits until the attending comes and takes over. This might be already too late and complicates the issue.
The beginners should be taught to reevaluate their watching approach and to give oxygen early on or suction when in doubt and not to leave it away if they are not sure.
To the Editor,
We thank Neonatal Resuscitation Program (NRP) Steering Committee for the comprehensive response and appreciate their kind comments towards our article.1 While we respect American Heart Association (AHA)/NRP for transparency, we do agree with excellent commentary by Dr. Wiswell that there was no compelling evidence that harm outweighed the benefit of endotracheal suctioning in nonvigorous meconium stained newborns to recommend revision of decades of routine practice.2,3 We strongly believe that a large randomized controlled trial is needed to have a definitive answer to the question concerning optimal management of nonvigorous newborns born through meconium stained amniotic fluid (MSAF).
Our practice has a resuscitation team, including a neonatal provider proficient in intubation to attend deliveries associated with MSAF. The determination of newborn being vigorous or nonvigorous was made soon after birth by the resuscitation team during both retrospective and prospective time periods. During the prospective time period, when appeared nonvigorous, the newborn was handed over by the obstetric provider to the neonatal provider and routine initial steps of resuscitation were performed on the warmer. The label of “nonvigorous” was given before initial stimulation was performed. We do not believe that the prospective nonvigorous cohort in our study was “sicker” than the retrospective cohort given the fact that only 55% needed positive pressure ventilation. Rest of them responded to routine initial steps of resuscitation, such as drying and stimulation. The 1 and 5 minute Apgar scores and the proportion of newborns with 1 minute Apgar score <3 and/or 5 minute Apgar score <7 was similar between both retrospective and prospective groups. We agree that other practices may be different from ours and hence the incidence of meconium aspiration syndrome (MAS) needs to be monitored with different denominators, such as all the term newborns or all the term newborns born through MSAF. However, as the major revision was in the management of nonvigorous newborns, it was important to report the change with the denominator being all the nonvigorous meconium stained newborns. There was a risk of diluting the effect of the change with the denominator being all newborns born through MSAF as we know majority of meconium stained newborns are vigorous (~90%), however nonvigorous newborns are at higher risk for respiratory issues, including MAS.
As for now, we respectfully follow NRP suggestions while we await more published evidence. In addition, we will continue to monitor our practice over a longer period of time and plan to present the respiratory data after adjustment of risk factors on all term newborns born through MSAF as suggested by Dr. Lakshminrusimha in his comment.
Respectfully,
Arpitha Chiruvolu
References
1) Chiruvolu A, Miklis KK, Chen E, et al. Delivery Room management of meconium stained newborns and respiratory support. Pediatrics. 2018; 142(6):e20181485.
2) Wiswell TE. Appropriate management of the nonvigorous meconium-stained neonate: An unanswered question. Pediatrics. 2018; 142(6):e20183052.
3) Wyckoff MH, Aziz K, Escobedo MB, et al. Part 13: Neonatal resuscitation: 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care (reprint). Pediatrics. 2015; 136(suppl 2):S196–S218.
Conflict of Interest
None
The seventh edition of the Neonatal Resuscitation Program (NRP) in 2016 included the statement that there is insufficient published human evidence to suggest routine tracheal intubation for suctioning of meconium in non-vigorous infants born through meconium-stained amniotic fluid (MSAF). This was the most recent in a series of changes in managing these infants over the last two decades.1 In 2000, Wiswell et al published an elegant, multicenter, randomized controlled trial (RCT) evaluating tracheal suctioning among 2094 vigorous infants born with MSAF, which demonstrated no difference in outcome.2 This high-quality evidence led to a change in NRP recommendations against routine tracheal suctioning for vigorous infants born through MSAF. Similarly, the recommendations against amnioinfusion, and deep suctioning of the mouth and nose after delivery of the head were based on robust, high quality, multicenter RCTs involving 1998 and 2514 subjects, respectively.3,4
The American Heart Association (AHA)/NRP suggestion regarding non-routine tracheal intubation for suctioning of meconium in non-vigorous infants born through MSAF was published in October 2015.5,6 NRP recommended implementation of these guidelines on or before January 1, 2017. The process for adoption of the recommendations was different from past processes in that AHA/NRP did not require a definitive RCT to change the recommendation, but instead concluded that there had been insufficient historical evidence on which to base the earlier recommendation for routine suctioning. The International Liaison Committee on Resuscitation (ILCOR) had conducted a vigorous systematic review of all available studies on this question.
The AHA/NRP was transparent in describing the values and preferences employed in changing the recommendation. There is unmeasured risk both in continuing to routinely suction the trachea in non-vigorous newborns and in not routinely suctioning the trachea in non-vigorous newborns. The values that guided the revision of the recommendation were to minimize the risks of intubation and to decrease the time to positive pressure ventilation (PPV) for the compromised newborn, given the lack of evidence to support benefit from routine tracheal suctioning.7-11
As recommended by Dr. Wiswell12, ongoing surveillance following significant changes to the NRP algorithm is very important. We applaud Dr. Chiruvolu and her colleagues for conducting such analysis and reporting their findings.13 We agree that the findings reported by Chiruvolu et al regarding an increased risk of respiratory disease in 101 non-vigorous neonates born after the NRP algorithm change compared to 130 non-vigorous neonates born prior to the change are concerning and warrant prospective study. Several other observational studies, including large, population-based registries regarding this recommendation are ongoing. Both ILCOR and the NRP Steering Committee are awaiting the publication of these studies and plan to incorporate the findings into a forthcoming systematic review.
The limitations of this observational study are seen in other studies looking at this question. One under-recognized issue with this particular topic is the definition of the denominator used for calculations. Based on previous guidelines, apparent (or ‘visibly appearing’) non-vigorous infants were not stimulated, but promptly transferred to the radiant warmer for tracheal suctioning. With the revised guidelines, obstetric and neonatal providers would likely stimulate these infants immediately after birth and may potentially label them as ‘non-vigorous’ only if they do not respond to initial stimulation. This may lead to a sicker cohort of infants receiving resuscitation and being included in the ‘non-vigorous’ denominator. It is thus important to monitor the rates of Meconium Aspiration Syndrome (MAS) in the entire birth cohort and in all neonates with MSAF, and not just among a decreasing denominator of potentially more sick, ‘non-vigorous’ neonates, in which rates of respiratory disease may appear to increase.
The NRP Steering Committee develops educational materials based on recommendations of ILCOR. Not only does ILCOR evaluate and make recommendations based on the quality of available evidence, they also develop a values and preferences statement to provide transparency to the process. While the NRP Steering Committee agrees that additional information is needed to have clarity on best practice for non-vigorous neonates delivered through MSAF, the NRP Steering Committee would impose a conflict of interest by independently driving that science and then developing recommendations. It is not the mission of the NRP to build the evidence that guides the recommendations, but rather to develop educational materials that implement the American Heart Association treatment guidelines that are supported by the ILCOR consensus on science.
We thank Drs. Wiswell and Chiruvolu et al for their thoughtful editorial and timely manuscript, respectively. The NRP Steering Committee will continue to closely follow abstracts, publications and database reports and evaluate the impact of changing NRP recommendations. We encourage obstetric and neonatal providers and managers of clinical databases to continue reporting through peer reviewed manuscripts changes in morbidity and mortality among neonates. Until more high-quality evidence is available, the NRP Steering Committee continues to affirm that there is insufficient published human evidence to suggest routine tracheal intubation for suctioning of meconium in non-vigorous infants born through MSAF.
Respectfully,
The NRP Steering Committee
References:
1. Textbook of Neonatal Resuscitation. American Academy of Pediatrics; 2016.
2. Wiswell TE, Gannon CM, Jacob J, et al. Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial. Pediatrics. Jan 2000;105(1 Pt 1):1-7.
3. Fraser WD, Hofmeyr J, Lede R, et al. Amnioinfusion for the prevention of the meconium aspiration syndrome. N Engl J Med. Sep 1 2005;353(9):909-917.
4. Vain NE, Szyld EG, Prudent LM, Wiswell TE, Aguilar AM, Vivas NI. Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial. Lancet. Aug 14-20 2004;364(9434):597-602.
5. Wyckoff MH, Aziz K, Escobedo MB, et al. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Reprint). Pediatrics. Oct 14 2015.
6. Perlman JM, Wyllie J, Kattwinkel J, et al. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations (Reprint). Pediatrics. Oct 14 2015.
7. Chettri S, Adhisivam B, Bhat BV. Endotracheal Suction for Nonvigorous Neonates Born through Meconium Stained Amniotic Fluid: A Randomized Controlled Trial. The Journal of pediatrics. May 2015;166(5):1208-1213 e1201.
8. Falciglia HS. Failure to prevent meconium aspiration syndrome. Obstetrics and gynecology. Mar 1988;71(3 Pt 1):349-353.
9. Linder N, Aranda JV, Tsur M, et al. Need for endotracheal intubation and suction in meconium-stained neonates. The Journal of pediatrics. Apr 1988;112(4):613-615.
10. Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates-A pilot study. Resuscitation. Aug 2016;105:79-84.
11. Narayan Singh S. Effect of endotracheal suctioning just after birth in non-vigorous infants born through meconium stained amniotic fluid: A randomized controlled trial. Clinical Epidemiology and Global Health. 2018.
12. Wiswell TE. Appropriate Management of the Nonvigorous Meconium-Stained Neonate: An Unanswered Question. Pediatrics. Nov 1 2018.
13. Chiruvolu A, Miklis KK, Chen E, Petrey B, Desai S. Delivery Room Management of Meconium-Stained Newborns and Respiratory Support. Pediatrics. Nov 1 2018.
To the Editor,
We read the recent article, “Delivery room management of meconium stained newborn and respiratory support” by Chiruvolu et al in Pediatrics with great interest.1 We commend Dr. Chiruvolu and her colleagues for conducting this study. They compared the incidence of NICU admissions for respiratory distress and meconium aspiration syndrome (MAS) when tracheal suction was performed in 70% of 130 non-vigorous infants born with MSAF to a group of 101 non-vigorous infants born through MSAF after 10/1/16. Only 2% of these 101 infants underwent tracheal suction. While the incidence of MAS (7/130 and 11/101) among non-vigorous infants born through MSAF did not differ between the two epochs, there was a significant increase in the incidence of NICU admissions for respiratory indications, surfactant use, oxygen therapy and mechanical ventilation in these comparison groups.
An important factor that needs to be taken into consideration is the ideal denominator while reporting the incidence of MAS and other perinatal outcomes. The incidence will differ based on the denominator – all births, all term births, infants with MSAF, or non-vigorous infants born through MSAF. The number of non-vigorous infants can vary from the time of birth to the point of evaluation by the neonatal provider based on factors such as delayed cord clamping and stimulation by the obstetric team.
While the incidence of deliveries complicated by MSAF in this study was similar between the routine suction and no-suction epochs (12%), the incidence of non-vigorous infants decreased from 10% to 8% possibly secondary to stimulation at birth by obstetric and neonatal providers. The unadjusted odds ratio for respiratory admissions to the NICU in the second epoch compared to the first using data provided by Chiruvolu et al is 2.28 (1.29, 4.05) if the denominator is non-vigorous infants with MSAF1 , but is 1.41 (0.87, 2.30) for all infants with MSAF and 1.44 (0.89, 2.32) for all births.
The number of infants with MAS in this study was small (n=18). The incidence of fetal distress, proportion of late preterm and post-term infants (factors increasing the risk of respiratory distress) were higher in the second epoch. Although the final analysis was adjusted for these factors, the inclusion of late preterm infants can partly explain the difference in admissions with respiratory distress. In addition, the authors define pulmonary hypertension in their methods and it would be of interest to report the rate of pulmonary hypertension in the two epochs.
We thank Dr. Chiruvolu et al and her colleagues for this timely manuscript. We request they provide data on incidence of respiratory admissions, pulmonary hypertension, and MAS in term infants (≥ 37 weeks) after adjustment of risk factors for all infants born with MSAF.
Congratulation but the real problem is the newborn resuscitation present practices:
1) Keeping the babies with respiratory distress and meconium aspiration blue over 10 minutes in the delivery room resulting in higher higher NICU admissions and their suffering.
2) Newborn babies brain after birth needs about 9-12 mL of oxygen per minute ( 3-4 mL/ 100 gm of brain tissues ). Hypoxia causes brain damages and at least put the children behind their class in this competitive World.
3) Instead of waiting and watching oxygen saturation for 10 minutes with babies with respiratory distress and gasping for oxygen we should provide oxygen with Ambu bag/Neo puff with PPV aggressively. They will improve and can avoid NICU admissions.
4) Pulse oxymetry don't pick up for couple of minutes because of poor perfusion.
Resuscitation of full term babies with room air until the HR drops less than 60/minute particularly meconium is simply harming their brain and destroying their future.
We should concentrate to make them better ASAP immediately after birth that is the key to success.
Thanks and Regards to all of you including respected NRP committee members.
Dr. Kanjilal