CONTEXT

Positive pressure ventilation (PPV) is the most important intervention during neonatal resuscitation.

OBJECTIVE

To compare T-piece resuscitators (TPRs), self-inflating bags (SIBs), and flow-inflating bags for newborns receiving PPV during delivery room resuscitation.

DATA SOURCES

Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, and trial registries (inception to December 2020).

STUDY SELECTION

Randomized, quasi-randomized, interrupted time series, controlled before-and-after, and cohort studies were included without language restrictions.

DATA EXTRACTION

Two researchers independently extracted data, assessed the risk of bias, and evaluated the certainty of evidence. The primary outcome was in-hospital mortality. When appropriate, data were pooled by using fixed-effect models.

RESULTS

Meta-analysis of 4 randomized controlled trials (1247 patients) revealed no significant difference between TPR and SIB for in-hospital mortality (risk ratio 0.74; 95% confidence interval [CI] 0.40 to 1.34). Resuscitation with a TPR resulted in a shorter duration of PPV (mean difference −19.8 seconds; 95% CI −27.7 to −12.0 seconds) and lower risk of bronchopulmonary dysplasia (risk ratio 0.64; 95% CI 0.43 to 0.95; number needed to treat 32). No differences in clinically relevant outcomes were found in 2 randomized controlled trials used to compare SIBs with and without positive end-expiratory pressure valves. No studies used to evaluate flow-inflating bags were found.

LIMITATIONS

Certainty of evidence was very low or low for most outcomes.

CONCLUSIONS

Resuscitation with a TPR compared with an SIB reduces the duration of PPV and risk of bronchopulmonary dysplasia. A strong recommendation cannot be made because of the low certainty of evidence. There is insufficient evidence to determine the effectiveness of positive end-expiratory pressure valves when used with SIBs.

During perinatal transition from intrauterine to extrauterine life, multiple physiologic changes must occur to accomplish the switch from placental gas exchange to pulmonary gas exchange.1,2  Approximately 85% of term infants achieve the transition without any assistance, another 10% initiate respirations in response to stimulation and drying, and ∼5% need positive pressure ventilation (PPV).35  The large number of births worldwide means that timely intervention with the appropriate equipment can help save millions of infants’ lives each year. It is established that PPV is the most important intervention during neonatal resuscitation, and the equipment for providing PPV has been extensively assessed in bench and animal studies.612  Although appropriate treatment with suitable devices can be life-saving, inappropriate use or inadequate equipment can have detrimental effects. With animal experiments, Björklund et al11  showed that a few excessive, manually delivered inflations at birth can lead to biochemical, structural, and functional alterations of the lungs that initiate the pathophysiologic pathway leading to bronchopulmonary dysplasia (BPD).12  At present, respiratory support immediately after birth is commonly provided by 3 types of devices: the flow-inflating bag (FIB), self-inflating bag (SIB), and T-piece resuscitator (TPR) system.2,13  With benchtop studies, researchers confirm that compared with the SIB, the TPR delivers more consistent peak inspiratory pressures and tidal volumes.8,9  Moreover, a ventilation device that can provide positive end-expiratory pressure (PEEP) at birth is recommended by the American Heart Association and the European Resuscitation Council Guidelines for Resuscitation14,15  because PEEP promotes lung-liquid clearance and the establishment of functional residual capacity (FRC) immediately after birth.1618 

A systematic review (SR) conducted in 2015 by the International Liaison Committee on Resuscitation (ILCOR) concluded that “there is insufficient evidence, so the recommendation of one device over another would be purely speculative because the confidence in effect estimates is so low.”19  Since then, further randomized controlled trials (RCTs) and 1 large observational study have been published.2022  On the basis of this new evidence, a recent scoping review conducted by ILCOR Neonatal Life Support (NLS) Task Force suggested that an updated SR of the literature was indicated to best inform treatment recommendations and international resuscitation guidelines.23 

In this SR, we compared different devices to administer PPV during neonatal resuscitation. We considered 4 specific comparisons: (1) TPR versus SIB, (2) TPR versus FIB, (3) FIB versus SIB, and (4) SIB with PEEP valve versus SIB without PEEP valve.

In cooperation with the ILCOR NLS Task Force, this SR and meta-analysis was undertaken as part of the continuous evidence evaluation process leading to the development of the ILCOR Consensus on Science with Treatment Recommendations. The SR and meta-analysis conform with the methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions24  and is reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for meta-analysis in health care interventions.25  The protocol was registered before article selection with the Prospective Register of Systematic Reviews (PROSPERO) (registered September 3, 2020; PROSPERO [identifier CRD42020200331]). On October 16, 2020, the protocol was updated in the PROSPERO register when the ILCOR NLS Task Force recommended adding an additional comparison (SIB with PEEP valve versus SIB without PEEP valve) to the original protocol.

RCTs or quasi-randomized RCTs, interrupted time series, controlled before-and-after studies, and cohort studies were eligible for inclusion without language restrictions.

Review articles, editorials, comments, case reports, unpublished studies (eg, conference abstracts, trial protocols), small case series (<10 patients), animal, and mannequin studies were excluded. Study authors were contacted, when appropriate, to request additional unpublished data. Eligible studies were those in which researchers recruited newborns who received PPV using an SIB, FIB, or TPR during resuscitation.

With this SR, we addressed the Population, Intervention, Comparator, Outcome, Study Design and Timeframe (PICOST) questions that were created by the ILCOR NLS Task Force and approved by the ILCOR Scientific Advisory Committee (Supplemental Table 7).

The choices of outcomes using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) classifications of critical or important were debated by the task force and were based on aconsensus outcome rating for international neonatal resuscitation guidelines.26  The primary outcome was in-hospital mortality. Secondary outcomes included intraventricular hemorrhage (IVH) of any grade, IVH grades III to IV, BPD, cardiopulmonary resuscitation (CPR), or medications in delivery room (DR), air leak, intubation in DR, duration of PPV in DR, length of hospital stay, and admission to NICU. IVH grades were defined on the basis of Papile et al27 ; BPD was defined as receiving supplemental oxygen at 36 weeks’ postmenstrual age for newborns <32 weeks or for >28 days in those >32 weeks’ gestational age (as specified by individual study authors).28 

Literature searches in Medline, Embase, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, the Cochrane Methodology Register, the Database of Abstracts of Reviews of Effects, and Cumulative Index to Nursing and Allied Health Literature were conducted by an information specialist from the Oxford Library (Oxford, United Kingdom) in close consultation with the review team. The search strategies for each database are shown in the Supplemental Information. The date range of the initial search was from database inception to August 19, 2020. The subject headings and keywords were adapted for the respective databases. The initial search was updated on December 31, 2020.

In addition, we searched references of the ILCOR 201029  and 201530  Consensus on Science with Treatment Recommendations and searched for ongoing clinical trials or unpublished work in the following registries through December 31, 2020: International Clinical Trials Registry Platform (who.int), US clinical trials registry (ClinicalTrials.gov), Cochrane Central Register of Controlled Trials (cochranelibrary.com), European Union Clinical Trials Register (clinicaltrialsregister.eu), Australian New Zealand Clinical Trials Registry (anzctr.org.au). Principal investigators of registered clinical trials that had not yet been published were contacted.

Two authors (D.T. and C.C.R.) independently screened titles and abstracts. In the event of a disagreement at abstract screening, the full text was reviewed. Pairs of independent reviewers subsequently completed full-text review to determine eligibility. Disagreements were resolved by consensus of the review team at the full-text stage. The first reason for exclusion was captured according to a predetermined, ordered list of exclusions. Interrater agreement for article selection was assessed by using Cohen’s κ coefficient at the abstract and full-text stages.

For each study, pairs of authors independently extracted predetermined study characteristics and study outcomes and then achieved consensus. Pairs of independent authors (D.T. and G.M.W.) evaluated risk of bias (RoB) in individual studies using the Cochrane risk-of-bias tool for RCTs and the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool for observational studies.24,31  Similarly, 2 authors assessed the certainty of evidence (confidence in the estimate of effect) for each outcome on the basis of the GRADE framework, including calculating the optimal information size to assess imprecision (GRADEpro Guideline Development Tool; McMaster University, Hamilton, Ontario, Canada; 2015; available from gradepro.org).32  The RoB and GRADE assessments were then reviewed by the other authors (who are also ILCOR NLS Task Force content experts) to achieve consistency and consensus.

GRADEPro and Review Manager software (version 5.3; The Nordic Cochrane Centre, Copenhagen, Denmark; 2014) were used to abstract, summarize, and analyze the data. Meta-analyses were performed if ≥2 studies were available. Heterogeneity was measured by using the I2 statistic.24,33 

Trials were combined by using the fixed-effect model, regardless of statistical evidence of heterogeneity or effect sizes. Pooled unadjusted risk ratios (RRs) and corresponding 95% confidence intervals (CIs) are reported by using the Mantel-Haenszel method for dichotomous variables. The absolute risk difference and number needed to treat (NNT) were calculated when the pooled estimate from trials revealed a statistically significant benefit or harm.

Continuous variables were reported as mean differences (MDs) and corresponding 95% CIs by using the Mantel-Haenszel method. Forest plots were used for graphical representation of RRs and MDs. Prespecified subgroup analyses were planned according to (1) gestational age (term infants, preterm infants 28–36 weeks’ gestation, or preterm infants <28 weeks’ gestation) and (2) characteristics of the SIB (SIB with and without PEEP valve).

The search strategy identified 1509 records. One additional study21  was identified by the authors. After removing 602 duplicates, 908 records were screened by title and abstract, and 885 were excluded. In total, 23 full-text articles were assessed for eligibility and 6 were included in the final review (Fig 1).7,8,13,2023,3449  TheCohen’s κ coefficient was 0.58 (moderate agreement) at the abstract stage and 1.0 (full agreement) at the full-text stage. The PRISMA study selection diagram, including the reasons for article exclusion, is shown in Fig 1. Searching clinical trial registries did not find any additional studies.

FIGURE 1

PRISMA flow diagram of study selection.

FIGURE 1

PRISMA flow diagram of study selection.

Close modal

Characteristics of included studies are reported in Table 1. For the comparison between PPV using a TPR and SIB, 4 RCTs20,21,34,35  and 1 retrospective cohort study22  were included. Of a total 3209 patients, 1247 were enrolled in RCTs, and 1962 were enrolled in the cohort study. One RCT included infants with gestational age <29 weeks and the other 3 RCTs included mainly term infants. The observational study included infants between 23 and 33 weeks’ gestation and birth weight between 400 and 1499 g. For the subgroup comparison between SIBs with and without a PEEP valve, 881 patients receiving PPV with SIB were included from 2 RCTs enrolling 1444 patients.35,49  Both studies enrolled mainly term infants. We did not identify any eligible studies comparing a TPR with an FIB or an FIB with an SIB.

TABLE 1

Study Characteristics

Study CharacteristicsOutcomes
StudyYears of RecruitmentCountryMulti- or Single CenterStudy DesignPatients, N/Gestational AgeIn-Hospital MortalityIVH (All Grades)Severe IVH (Grades III–IV)BPDDR Interventions (ETT/CPR or Medications)Duration of PPV in DRAir LeakAdmission to NICULength f Hospital Stay
Dawson et al34  February 2007 to February 2009 Australia Single RCT 80/<29 wk − − +/+ − − 
Szyld et al35,a December 2009 to August 2012 Argentina, Chile, Italy, Peru, United States Multisite (10 centers) RCT 1027/≥26 wk − − +/+ 
Thakur et al20  August 2010 to August 2011 India Single RCT 90/>26 wk − − − +/+ 
Guinsburg et al22  January 2014 to December 2015 Brazil Multisite (20 academic tertiary centers) Prospective cohort study 1962/23–33 wk and birth wt 400–1499 g +/+ − 
Kookna et al21  NA India Single RCT 50/≥28 wk − − +/+ − − 
Holte et al49,b September 2016 to June 2018 Tanzania Single RCT 417/newborns approximately term − −  −/− − 
Study CharacteristicsOutcomes
StudyYears of RecruitmentCountryMulti- or Single CenterStudy DesignPatients, N/Gestational AgeIn-Hospital MortalityIVH (All Grades)Severe IVH (Grades III–IV)BPDDR Interventions (ETT/CPR or Medications)Duration of PPV in DRAir LeakAdmission to NICULength f Hospital Stay
Dawson et al34  February 2007 to February 2009 Australia Single RCT 80/<29 wk − − +/+ − − 
Szyld et al35,a December 2009 to August 2012 Argentina, Chile, Italy, Peru, United States Multisite (10 centers) RCT 1027/≥26 wk − − +/+ 
Thakur et al20  August 2010 to August 2011 India Single RCT 90/>26 wk − − − +/+ 
Guinsburg et al22  January 2014 to December 2015 Brazil Multisite (20 academic tertiary centers) Prospective cohort study 1962/23–33 wk and birth wt 400–1499 g +/+ − 
Kookna et al21  NA India Single RCT 50/≥28 wk − − +/+ − − 
Holte et al49,b September 2016 to June 2018 Tanzania Single RCT 417/newborns approximately term − −  −/− − 

ETT, endotracheal tube; NA, not available; +, xxx; −, xxx.

a

Included in comparison 1 (TPR versus SIB) and comparison 4 (SIB with PEEP valve versus SIB without PEEP valve).

b

Included in comparison 4 (SIB with PEEP valve versus SIB without PEEP valve).

Patient characteristics of included studies are shown in Table 2. In all studies, patient characteristics were well matched between the groups.

TABLE 2

Patient Characteristics

StudyTreatmentNGestational Age, Median (IQR) or Mean ± SD, wkMale Sex, n (%)Birth wt, Median (IQR) or Mean ± SD, gCesarean Delivery, n (%)Apgar Score, Median (IQR) or Mean ± SD
RCT        
 Dawson et al34  TPR 41 27 (1) 22 (54) 873 (236) 28 (68) 7 (6–8) 
 SIB 39 27 (1) 23 (59) 899 (206) 32 (82) 7 (6–9) 
 Szyld et al35  TPR 511 36 ± 4.1 303 (59) 2720 ± 1025 262 (51) 30 (6)a 
 SIB 516 36 ± 4.4 298 (58) 2686 ± 1069 290 (56) 47 (9)a 
 Thakur et al20  TPR 40 34 ± 3 20 (50) 2065 ± 814 NA 8 (7–9) 
 SIB 50 35 ± 3 32 (64) 2264 ± 872 NA 8 (7–9) 
 Kookna et al21  TPR 25 38 ± 1.5 17 (68) NA 14 (56) 8.6 ± 1.2 
 SIB 25 38 ± 1.9 12 (48) NA 11 (44) 8.0 ± 1.2 
 Holte et al49  SIB with PEEP valve 211 39 (37–40) 127 (69) 3150 (2590–3500) 92 (44) 37 (18)b 
 SIB without PEEP valve 206 38 (37–40) 112 (54) 3250 (2927–3600) 93 (45) 44 (21)b 
Observational study        
 Guinsburg et al22  TPR 1456 28 ± 2.2 745 (51) 969 ± 277 968 (67) 1104 (76)c 
 SIB 506 27 ± 2.7 258 (51) 941 ± 279 286 (57) 322 (64)c 
StudyTreatmentNGestational Age, Median (IQR) or Mean ± SD, wkMale Sex, n (%)Birth wt, Median (IQR) or Mean ± SD, gCesarean Delivery, n (%)Apgar Score, Median (IQR) or Mean ± SD
RCT        
 Dawson et al34  TPR 41 27 (1) 22 (54) 873 (236) 28 (68) 7 (6–8) 
 SIB 39 27 (1) 23 (59) 899 (206) 32 (82) 7 (6–9) 
 Szyld et al35  TPR 511 36 ± 4.1 303 (59) 2720 ± 1025 262 (51) 30 (6)a 
 SIB 516 36 ± 4.4 298 (58) 2686 ± 1069 290 (56) 47 (9)a 
 Thakur et al20  TPR 40 34 ± 3 20 (50) 2065 ± 814 NA 8 (7–9) 
 SIB 50 35 ± 3 32 (64) 2264 ± 872 NA 8 (7–9) 
 Kookna et al21  TPR 25 38 ± 1.5 17 (68) NA 14 (56) 8.6 ± 1.2 
 SIB 25 38 ± 1.9 12 (48) NA 11 (44) 8.0 ± 1.2 
 Holte et al49  SIB with PEEP valve 211 39 (37–40) 127 (69) 3150 (2590–3500) 92 (44) 37 (18)b 
 SIB without PEEP valve 206 38 (37–40) 112 (54) 3250 (2927–3600) 93 (45) 44 (21)b 
Observational study        
 Guinsburg et al22  TPR 1456 28 ± 2.2 745 (51) 969 ± 277 968 (67) 1104 (76)c 
 SIB 506 27 ± 2.7 258 (51) 941 ± 279 286 (57) 322 (64)c 

IQR, interquartile range; NA, not available.

a

5-min Apgar score ≤5, n (%).

b

5-min Apgar score ≤6, n (%).

c

5-min Apgar score of 7–10, n (%).

For the comparison between PPV using a TPR and SIB, the included RCTs had a high or unclear overall study-level RoB (Table 3). Using the ROBINS-I tool, the single observational study had a moderate RoB (Table 4).22  For the comparison between PPV using SIBs with and without a PEEP valve, both included RCTs35,49  had a high overall study-level RoB (Table 3).

TABLE 3

RoB Assessment According to Cochrane RCT Criteria

StudySequence GenerationAllocation ConcealmentBlinding of Participants and PersonnelBlinding of Outcome AssessorsIncomplete Outcome DataSelective Outcome ReportingOther Sources of BiasOverall Bias
Comparison 1: TPR versus SIB         
 Dawson et al34  Low Low High Unclear Low Low Low High 
 Szyld et al35  Higha Unclear High Unclear Low Low Low High 
 Thakur et al20  Higha Unclear High Unclear Low Low Low High 
 Kookna et al21  Low Unclear High Unclear Low Highb Low High 
Comparison 4: SIB with PEEP valve versus SIB without PEEP valve         
 Szyld et al35  Highc Unclear High Unclear Low Low Low High 
 Holte et al49  Highc Unclear High High Low Low Low High 
StudySequence GenerationAllocation ConcealmentBlinding of Participants and PersonnelBlinding of Outcome AssessorsIncomplete Outcome DataSelective Outcome ReportingOther Sources of BiasOverall Bias
Comparison 1: TPR versus SIB         
 Dawson et al34  Low Low High Unclear Low Low Low High 
 Szyld et al35  Higha Unclear High Unclear Low Low Low High 
 Thakur et al20  Higha Unclear High Unclear Low Low Low High 
 Kookna et al21  Low Unclear High Unclear Low Highb Low High 
Comparison 4: SIB with PEEP valve versus SIB without PEEP valve         
 Szyld et al35  Highc Unclear High Unclear Low Low Low High 
 Holte et al49  Highc Unclear High High Low Low Low High 
a

Two studies were quasi-randomized RCTs (cluster randomized, 2-period crossover trial and randomization on the date of month).

b

The study was not registered and protocol was not mentioned in the study.

c

Two studies were quasi-randomized RCTs (cluster randomized, 2-period crossover trial and randomization per week).

TABLE 4

RoB Assessment According to ROBINS-I Observational Studies Criteria

StudyBias due to ConfoundingBias in Selection of ParticipantsBias in Classification of InterventionsBias due to Deviations From Intended InterventionsBias due to Missing DataBias in Measurement of OutcomesBias in Selection of the Reported ResultsOverall Bias
Guinsburg et al22  Moderatea Moderateb Moderatec Moderated Low Low Low Moderatee 
StudyBias due to ConfoundingBias in Selection of ParticipantsBias in Classification of InterventionsBias due to Deviations From Intended InterventionsBias due to Missing DataBias in Measurement of OutcomesBias in Selection of the Reported ResultsOverall Bias
Guinsburg et al22  Moderatea Moderateb Moderatec Moderated Low Low Low Moderatee 
a

Confounding is expected: differences in maternal age, prenatal care, chorioamnionitis, steroids, cesarean delivery, gestational age, center use of T-piece, and clinician decision to use T-piece. Controlled by using logistic regression.

b

A small number of subjects were excluded after intervention because they were transferred to another unit. The proportion of participants for which this was the case is likely too low to induce important bias.

c

It is not clear from methods how it was determined if a T-piece or SIB was used at any time during resuscitation. Was this recorded at the time of resuscitation on a form or was it abstracted from the chart notes retrospectively?

d

Imbalance in a co-intervention (100%) oxygen between groups.

TPR Versus SIB

For the comparison between a TPR and an SIB, the primary outcome of in-hospital mortality was reported in all 4 RCTs (1247 patients).20,21,34,35  The meta-analysis found no difference between treatment groups (RR 0.74; 95% CI 0.40 to 1.34) (Fig 2A). In the single observational study,22  which only enrolled preterm newborns, a reduction of in-hospital mortality was associated with the use of a TPR compared with an SIB (RR 0.71; 95% CI 0.63 to 0.80; risk difference (RD)−0.13).

FIGURE 2

Comparison between TPR and SIB. A, Outcome: in-hospital mortality. B, Outcome: BPD. C, Outcome: duration (seconds) of PPV in DR. df, degrees of freedom; IV, inverse variance; MH, Mantel-Haenszel.

FIGURE 2

Comparison between TPR and SIB. A, Outcome: in-hospital mortality. B, Outcome: BPD. C, Outcome: duration (seconds) of PPV in DR. df, degrees of freedom; IV, inverse variance; MH, Mantel-Haenszel.

Close modal

When considering secondary outcomes, the meta-analysis of 4 RCTs revealed a reduction in the probability of BPD (Fig 2B) in the group receiving PPV with a TPR compared with an SIB (RR 0.64; 95% CI 0.43 to 0.95; RD −0.03; NNT 32).20,21,34,35  In addition, use of a TPR resulted in a small reduction in the duration of PPV (MD −19.8 seconds; 95% CI −27.7 to −12.0 seconds) (Fig 2C). No difference was found in the probability of intubation in the DR, use of CPR or medications during DR resuscitation, admission to the NICU, air leak, or length of hospital stay (Table 5). To assess the outcome of IVH (all grades) and severe IVH (grades III to IV), unpublished data were provided by 2 study authors, Thakur et al20  and Szyld et al.35  Both studies showed no difference in the probability of IVH or severe IVH (IVH all grades). For IVH, Szyld et al35  foundan RR or 1.17 (95% CI 0.64 to 2.13) and Thakur et al20  found an RR of 5.00 (95% CI 0.58 to 42.99). For severe IVH, Szyld et al35  found an RR of 2.78 (95% CI 0.89 to 8.66) and Thakur et al20  found an RR of 2.15 (95% CI 0.31 to 125.98). Because this was not a planned outcome for the Szyld et al35  multicenter RCT, there was no standardized protocol for assessment or reporting of IVH. Given the unbalanced distribution of very low birth weight infants after cluster random assignment, the large variation in IVH between centers, and the inability to adjust for confounders, the primary author of the RCT provided the data but expressed uncertainty about their reliability. As a result, the SR team determined these data had a critically high RoB and did not combine them for meta-analyses.

TABLE 5

Summary of GRADE Assessment (Comparison 1: TPR Versus SIB)

Certainty AssessmentNo. PatientsEffect
No. StudiesStudy DesignRoBInconsistencyIndirectnessImprecisionOther ConsiderationsTPRSIBRR (95% CI)Absolute Risk (95% CI)CertaintyImportance
In-hospital mortality Randomized trials Seriousa Not serious Seriousb Seriousc None 17 of 617 (2.8%) 24 of 630 (3.8%) 0.74 (0.40 to 1.34) 10 fewer per 1000 (from 23 fewer to 13 more) ⨁◯◯◯ Very low Critical 
Air leak Randomized trials Seriousa Not serious Serious Seriousc None 14 of 617 (2.3%) 11 of 630 (1.7%) 1.29 (0.60 to 2.77) 5 more per 1000 (from 7 fewer to 31 more) ⨁◯◯◯ Very low Important 
BPD Randomized trials Seriousa Seriousd Seriousb Not serious None 36 of 617 (5.8%) 56 of 630 (8.9%) 0.64 (0.43 to 0.95) 32 fewer per 1000 (from 51 fewer to 4 fewer) ⨁◯◯◯ Very low Important 
Duration of PPV in DR Randomized trials Seriousa Not serious Not serious Not serious None   — MD 19.8 lower (27.7 lower to 12 lower) ⨁⨁⨁◯ Moderate Important 
Intubation in DR Randomized trials Seriousa Seriousd Seriousb Not serious None 186 of 625 (29.8%) 214 of 641 (33.4%) 0.89 (0.76 to 1.05) 37 fewer per 1000 (from 80 fewer to 17 more) ⨁◯◯◯ Very low Important 
CPR or medications in DR Randomized trials Seriousa Not serious Seriousb Seriouse None 10 of 617 (1.6%) 18 of 630 (2.9%) 0.58 (0.28 to 1.23) 12 fewer per 1000 (from 21 fewer to 7 more) ⨁◯◯◯ Very low Important 
Admission to NICU Randomized trials Seriousa Not serious Seriousb Not serious None 342 of 590 (58.0%) 353 of 594 (59.4%) 0.98 (0.89 to 1.07) 12 fewer per 1000 (from 65 fewer to 42 more) ⨁⨁◯◯ Low Important 
Length of hospitalization Randomized trials Seriousf Not serious Not serious Not serious None 543 547 — MD 0.25 lower (3.39 lower to 2.89 higher) ⨁⨁⨁◯ Moderate Important 
Certainty AssessmentNo. PatientsEffect
No. StudiesStudy DesignRoBInconsistencyIndirectnessImprecisionOther ConsiderationsTPRSIBRR (95% CI)Absolute Risk (95% CI)CertaintyImportance
In-hospital mortality Randomized trials Seriousa Not serious Seriousb Seriousc None 17 of 617 (2.8%) 24 of 630 (3.8%) 0.74 (0.40 to 1.34) 10 fewer per 1000 (from 23 fewer to 13 more) ⨁◯◯◯ Very low Critical 
Air leak Randomized trials Seriousa Not serious Serious Seriousc None 14 of 617 (2.3%) 11 of 630 (1.7%) 1.29 (0.60 to 2.77) 5 more per 1000 (from 7 fewer to 31 more) ⨁◯◯◯ Very low Important 
BPD Randomized trials Seriousa Seriousd Seriousb Not serious None 36 of 617 (5.8%) 56 of 630 (8.9%) 0.64 (0.43 to 0.95) 32 fewer per 1000 (from 51 fewer to 4 fewer) ⨁◯◯◯ Very low Important 
Duration of PPV in DR Randomized trials Seriousa Not serious Not serious Not serious None   — MD 19.8 lower (27.7 lower to 12 lower) ⨁⨁⨁◯ Moderate Important 
Intubation in DR Randomized trials Seriousa Seriousd Seriousb Not serious None 186 of 625 (29.8%) 214 of 641 (33.4%) 0.89 (0.76 to 1.05) 37 fewer per 1000 (from 80 fewer to 17 more) ⨁◯◯◯ Very low Important 
CPR or medications in DR Randomized trials Seriousa Not serious Seriousb Seriouse None 10 of 617 (1.6%) 18 of 630 (2.9%) 0.58 (0.28 to 1.23) 12 fewer per 1000 (from 21 fewer to 7 more) ⨁◯◯◯ Very low Important 
Admission to NICU Randomized trials Seriousa Not serious Seriousb Not serious None 342 of 590 (58.0%) 353 of 594 (59.4%) 0.98 (0.89 to 1.07) 12 fewer per 1000 (from 65 fewer to 42 more) ⨁⨁◯◯ Low Important 
Length of hospitalization Randomized trials Seriousf Not serious Not serious Not serious None 543 547 — MD 0.25 lower (3.39 lower to 2.89 higher) ⨁⨁⨁◯ Moderate Important 

—, not applicable.

a

In 2 studies, the RoB for sequence generation was high; in all studies, personnel was aware of the intervention group.

b

In 1 study, only preterm infants with gestational age <29 wk were included; 1 study included almost only term infants.

c

CIs do include null effect and do include appreciable benefit or harm.

d

There was heterogeneity between the studies (I2 > 25%).

e

The No. enrolled patients was less than the optimal information size.

f

In both studies, the RoB for sequence generation was high and personnel was aware of the intervention group.

In the observational study,22  use of a TPR compared with an SIB was associated with reduced risk of IVH (RR 0.72; 95% CI 0.63 to 0.83; RD −0.13), severe IVH (RR 0.75; 95% CI 0.57 to 0.98; RD −0.04), BPD (RR 0.79; 95% CI 0.65 to 0.96; RD −0.07), and intubation in the DR (RR 0.57; 95% CI 0.46 to 0.70; RD −0.13). No difference was found between groups in the risk of air leak, CPR or medications in the DR, or length of hospital stay (Supplemental Table 8).

SIB With PEEP Valve Versus SIB Without PEEP Valve

For the comparison between an SIB with a PEEP valve and an SIB without a PEEP valve, the primary outcome of in-hospital mortality was reported in 2 RCTs (933 patients).35,49  The meta-analysis found no difference between treatment groups (RR 0.99; 95% CI 0.59 to 1.67) (Table 6). A small increase in the duration of hospital stay (MD 0.14 days; 95% CI 0.01 to 0.27 days) was found in the group using SIB with a PEEP valve. No difference was found in the other secondary outcomes, including the risk of air leak, BPD, intubation in the DR, use of CPR or medications in the DR, admission to the NICU, or the duration of PPV in the DR.

TABLE 6

Summary of GRADE Assessment (Comparison 4: SIB With PEEP Valve Versus SIB Without PEEP Valve)

Certainty AssessmentNo. PatientsEffect
No. StudiesStudy DesignRoBInconsistencyIndirectnessImprecisionOther ConsiderationsPPV With SIB With PEEP ValvePPV With SIB Without PEEP ValveRR (95% CI)Absolute Risk (95% CI)CertaintyImportance
Mortality at hospital discharge Randomized trials Seriousa Not serious Seriousb Seriousc None 27 of 501 (5.4%) 25 of 432 (5.8%) 0.99 (0.59 to 1.67) 1 fewer per 1000 (from 24 fewer to 39 more) ⨁◯◯◯ Very low Critical 
Air leak Randomized trials Seriousd Not serious Not serious Very seriousc,e None 6 of 290 (2.1%) 2 of 226 (0.9%) 2.30 (0.48 to 9.67) 12 more per 1000 (from 5 fewer to 77 more) ⨁◯◯◯ Very low Important 
BPD Randomized trials Seriousd Not serious Not serious Seriousc None 25 of 290 (8.6%) 19 of 226 (8.4%) 1.03 (0.58 to 1.81) 3 more per 1000 (from 35 fewer to 68 more) ⨁⨁◯◯ Low Important 
Duration of PPV Randomized trials Seriousa Not serious Seriousb Seriousc None 444 390 — MD 3.85 lower (29.47 lower to 21.77 higher) ⨁◯◯◯ Very low Important 
Intubation in DR; Randomized trials Seriousd Not serious Not serious Not serious None 81 of 290 (27.9%) 56 of 226 (24.8%) 1.19 (0.88 to 1.61) 47 more per 1000 (from 30 fewer to 151 more) ⨁⨁⨁◯ Moderate Important 
CPR or medications in DR Randomized trials Seriousd Not serious Not serious Very seriousc,e None 11 of 290 (3.8%) 6 of 226 (2.7%) 1.43 (0.54 to 3.80) 11 more per 1000 (from 12 fewer to 74 more) ⨁◯◯◯ Very low Important 
Admission to NICU Randomized trials Seriousa Seriousf Seriousb Not serious None 226 of 501 (45.1%) 168 of 432 (38.9%) 1.12 (0.96 to 1.30) 47 more per 1000 (from 16 fewer to 117 more) ⨁◯◯◯ Very low Important 
Length of hospitalization Randomized trials Seriousa Seriousf Seriousb Seriousc None 462 400 — MD 0.14 higher (0.01 higher to 0.27 higher) ⨁◯◯◯ Very low Important 
Certainty AssessmentNo. PatientsEffect
No. StudiesStudy DesignRoBInconsistencyIndirectnessImprecisionOther ConsiderationsPPV With SIB With PEEP ValvePPV With SIB Without PEEP ValveRR (95% CI)Absolute Risk (95% CI)CertaintyImportance
Mortality at hospital discharge Randomized trials Seriousa Not serious Seriousb Seriousc None 27 of 501 (5.4%) 25 of 432 (5.8%) 0.99 (0.59 to 1.67) 1 fewer per 1000 (from 24 fewer to 39 more) ⨁◯◯◯ Very low Critical 
Air leak Randomized trials Seriousd Not serious Not serious Very seriousc,e None 6 of 290 (2.1%) 2 of 226 (0.9%) 2.30 (0.48 to 9.67) 12 more per 1000 (from 5 fewer to 77 more) ⨁◯◯◯ Very low Important 
BPD Randomized trials Seriousd Not serious Not serious Seriousc None 25 of 290 (8.6%) 19 of 226 (8.4%) 1.03 (0.58 to 1.81) 3 more per 1000 (from 35 fewer to 68 more) ⨁⨁◯◯ Low Important 
Duration of PPV Randomized trials Seriousa Not serious Seriousb Seriousc None 444 390 — MD 3.85 lower (29.47 lower to 21.77 higher) ⨁◯◯◯ Very low Important 
Intubation in DR; Randomized trials Seriousd Not serious Not serious Not serious None 81 of 290 (27.9%) 56 of 226 (24.8%) 1.19 (0.88 to 1.61) 47 more per 1000 (from 30 fewer to 151 more) ⨁⨁⨁◯ Moderate Important 
CPR or medications in DR Randomized trials Seriousd Not serious Not serious Very seriousc,e None 11 of 290 (3.8%) 6 of 226 (2.7%) 1.43 (0.54 to 3.80) 11 more per 1000 (from 12 fewer to 74 more) ⨁◯◯◯ Very low Important 
Admission to NICU Randomized trials Seriousa Seriousf Seriousb Not serious None 226 of 501 (45.1%) 168 of 432 (38.9%) 1.12 (0.96 to 1.30) 47 more per 1000 (from 16 fewer to 117 more) ⨁◯◯◯ Very low Important 
Length of hospitalization Randomized trials Seriousa Seriousf Seriousb Seriousc None 462 400 — MD 0.14 higher (0.01 higher to 0.27 higher) ⨁◯◯◯ Very low Important 

—, not applicable.

a

In both studies, the RoB for random sequence generation and blinding of personnel was high.

b

Important differences in populations and treatments were found.

c

CIs do include null effect and do include appreciable harm and benefit.

d

The RoB was high for random sequence generation and blinding of personnel.

e

The No. enrolled patients was less than the optimal information size.

f

I2 > 25%.

Subgroup Analyses

The planned analyses by gestational age subgroups were not feasible because each of the included RCTs used different gestational age cutoffs.20,21,34,35 

In 1 cluster randomized crossover study, the authors allocated centers to either TPR or SIB.35  After 50 patients enrolled followed by a washout period, the center crossed over to the alternate device. During the SIB period, each center was assigned at random to use the SIB either with or without a PEEP valve. In this study, no differences were found for the primary outcome of in-hospital mortality or the secondary outcomes air leak and use of CPR or medications in the DR (Supplemental Table 8). Use of a TPR compared with an SIB with a PEEP valve was shown to decrease the risk of BPD (RR 0.49; 95% CI 0.25 to 0.95; RD −0.04; NNT 23). Use of a TPR compared with either SIB was shown to decrease the probability of intubation in the DR (TPR versus SIB with PEEP valve RR 0.69 [95% CI 0.51 to 0.93; RD −0.09; NNT 12]; TPR versus SIB without PEEP valve RR 0.58 [95% CI 0.39 to 0.88; RD −0.10; NNT 10]).

Certainty of Evidence (GRADE Analysis)

Most relevant outcomes selected for GRADE assessment were rated as very low or low certainty of evidence because of serious RoB and imprecision (Tables 5 and 6).

This SR and meta-analysis of 4 RCTs (1247 infants) comparing TPR and SIB revealed no significant difference in the risk of the primary outcome, in-hospital mortality.20,21,34,35  However, administering PPV with a TPR was associated with a shorter duration of PPV in the DR and decreased risk of BPD. Rates of secondary outcomes including air leak, intubation in DR, CPR or medications in DR, admission to NICU, and duration of hospital stay were similar between the 2 groups. Furthermore, a large multicenter cohort study involving preterm infants with gestational ages between 23 and 33 weeks revealed that critical outcomes, including in-hospital mortality, all grades of IVH, IVH grades III to IV, and BPD, were significantly reduced in the group receiving PPV with a TPR compared with the group receiving PPV with an SIB.22 

Approximately 5% of newborns (∼6 million worldwide per annum) receive PPV at birth. Identifying the most appropriate device for administering PPV is a priority because aerating the newborn’s lungs is the single most important step in neonatal resuscitation.26  It is important to determine which device effectively aerates the newborn’s lungs while avoiding lung injury with potential short-term (ie, pneumothorax, IVH) and long-term (ie, BPD) consequences.

The reduction of BPD in the TPR group may be explained by the mechanical advantages that the TPR offers compared with the SIB. The TPR provides more precise peak inflation pressure, decreases the probability of unintended high-pressure inflations, and allows the application of continuous positive airway pressure and PEEP.7,8,34,35  This may result in improved lung recruitment and more consistent establishment of an FRC. Szyld et al35  found that newborns resuscitated with an SIB received higher mean inflation pressures and were more likely to be exposed to an inflation pressure >25 cmcH2O.35  These higher inflation pressures may increase the risk of lung injury. Moreover, our pooled results revealed that resuscitation with the TPR resulted in a shorter duration (19.8 seconds) of PPV at birth. This finding was consistent across studies. However, it is unclear whether this small difference in ventilation time is clinically relevant. Although subgroup analyses by gestation were not feasible, BPD is mainly an outcome that affects very preterm infants.12  The reduction in BPD risk suggests that use of a TPR may benefit very preterm infants, and future studies should target this population.

For the critical outcomes of IVH and severe IVH, unpublished data were provided by the authors of a small quasi-randomized trial20  and a multicenter cluster randomized trial.35  Although neither study revealed a difference between the TPR and SIB, the point estimates from both studies favored the SIB. Because these data were considered to have a critically high RoB, the SR team consulted with the ILCOR NLS Task Force. Although IVH was an included outcome in the PROSPERO registration, the task force advised against combining these data for meta-analyses. In contrast, authors of the large prospective cohort study found that resuscitation with a TPR was associated with a significant decrease in the risk of IVH and severe IVH.22  Although the investigators for this study attempted to control for confounding using a logistic regression model, caution must be used in the interpretation of these results because of the risk of selection and classification bias. At present, there is insufficient evidence to evaluate the effect of PPV devices on IVH or other neurologic outcomes. Given the potential impact of DR ventilation on the development of brain injury in preterm newborns, additional research is warranted.50 

The TPR is widely used internationally.5154  It is likely that the costs of using a TPR are significantly higher than an SIB, which could result in health inequities in resource-limited settings. However, it is possible that a reduction in the risk of BPD among preterm infants may balance the costs associated with TPR in some of these settings. The cost-effectiveness of the TPR needs to be assessed in future studies.

PEEP may facilitate lung-liquid clearance and help establish FRC1618 ; hence, ventilator devices capable of providing PEEP are recommended by international organizations.14,15  However, the combined results from 2 trials involving 933 infants included in the present review revealed no differences in the primary outcome, or other critical and important outcomes, between using an SIB with or without a PEEP valve during neonatal resuscitation.33,49  Of note, these studies included mostly term newborns whose lungs are less vulnerable. They have better compliance and stiffer chest walls than preterm infants.55,56  The impact of SIBs with a PEEP valve on clinical outcomes merits further research, especially in preterm infants.

The strengths of this SR include a prespecified published protocol, a rigorous literature search developed by an information specialist, assessment of certainty of evidence using GRADE methodology, input from a team of international experts serving on the ILCOR NLS Task Force, and adherence to PRISMA guidelines. The present SR and meta-analysis has its limitations. Included studies were conducted in settings with different resources and different levels of operator experience and they enrolled different populations (exclusively very preterm versus mainly near term or term infants), which may have contributed to heterogeneity when pooling results. In addition, the specific TPRs and SIBs used were different. Variability of the performance characteristics of each device may have influenced the results. Overall, the certainty of evidence for most outcomes was low or very low because of serious RoB and imprecision. The certainty of evidence supporting the benefit of the TPR for the critical outcome BPD was very low because of serious RoB, inconsistency, and indirectness.20,21,34,35  For most critical and important outcomes included in the meta-analyses, the 95% CIs of RR were wide enough to include both potential harm and potential benefit.

The results of this SR revealed that DR resuscitation with a TPR compared with SIB reduced the duration of PPV and risk of BPD but did not change other critical and important outcomes. However, because of the serious RoB and low certainty of the evidence, it is not possible to make a strong recommendation in favor of the TPR. There is currently insufficient evidence to evaluate the effectiveness of PEEP valves when used with SIBs.

In this review, we did not find any clinical trials comparing different types of TPRs and SIBs against each other, although benchtop experiments demonstrate variations in performance that are of potential clinical importance.10,57,58  In future comparative studies, researchers should consider these important factors. In addition, we did not identify any eligible studies comparing a TPR with an FIB or studies comparing an FIB with an SIB. Studies comparing the FIB to either the TPR or the SIB (with or without PEEP valve) for neonatal resuscitation are indicated. Given the potential role of large inflations in the etiology of lung injury, future studies should assess the effect of delivering PPV with controlled and measurable tidal volumes compared with pressure-limited devices and whether PPV delivered through mechanical ventilators compared with hand-operated devices improves outcomes. Because data limitations prevented subgroup analyses by gestational age, future studies should assess the impact of the TPR compared with the SIB, with or without PEEP valves, in relation to standardized gestational age categories.

Besides the authors (D.T., C.C.R, P.G.D., G.M.S., H.G.L., M.H.W., Y.R., and G.M.W.), the following additional ILCOR NLS Task Force members provided input on the review protocol, the interpretation of the results, and the article as experts in neonatal resuscitation: Dr Maria Fernanda de Almeida, Federal University of Sao Paulo, Sao Paulo, Brazil; Dr Walid El-Naggar, Dalhousie University, Halifax, Nova Scotia, Canada; Dr Jorge Fabres, Universidad Católica de Chile, Santiago, Chile; Dr Joe Fawke, Leicester Royal Infirmary, Leicester, United Kingdom; Dr Elizabeth Foglia, University of Pennsylvania, Philadelphia, Pennsylvania; Dr Ruth Guinsburg, Federal University of Sao Paulo, Sao Paulo, Brazil; Dr Shigeharu Hosono, Jichi Medical University Saitama Medical Center, Saitama, Japan; Dr Tetsuya Isayama, National Center for Child Health and Development, Tokyo, Japan; Dr Vishal S. Kapadia, The University of Texas Southwestern Medical Center, Dallas, Texas; Dr Mandira Kawakami, Federal University of Sao Paulo, Sao Paulo, Brazil; Dr Han-Suk Kim, College of Medicine, Seoul National University, Seoul, Korea; Dr Chris McKinlay, University of Auckland, Auckland, New Zealand; Dr Jeffrey Perlman, Weill Cornell Medical College, Cornell University, New York, New York; Dr Takahiro Sugiura, Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan; Dr Jonathan Wyllie, James Cook University Hospital, South Tees National Health Service Foundation Trust, Middlesbrough, United Kingdom.

We thank Liz Callow (information specialist, Oxford) for her valuable support.

Dr Trevisanuto prepared the protocol, screened studies, abstracted data, completed risk-of-bias and Grading of Recommendations Assessment, Development and Evaluation evaluations, completed the analysis, and prepared the first draft of the manuscript; Dr Roehr reviewed the protocol, screened studies, abstracted data, reviewed the analysis, and prepared the first draft of the manuscript; Drs Davis, Schmölzer, Wyckoff, Liley, and Rabi were involved in reviewing the protocol, reviewing the analysis, and writing and editing the manuscript; Dr Weiner prepared the protocol, completed risk-of-bias and Grading of Recommendations Assessment, Development and Evaluation evaluations, completed the analysis, and was involved in writing and editing the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. This trial has been registered with the Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero) (identifier CRD42020200331).

This trial has been registered with the Prospective Register of Systematic Reviews (https://www.crd.york.ac.uk/prospero) (identifier CRD42020200331).

FUNDING: No external funding.

BPD

bronchopulmonary dysplasia

CI

confidence interval

CPR

cardiopulmonary resuscitation

DR

delivery room

FIB

flow-inflating bag

FRC

functional residual capacity

GRADE

Grading of Recommendations, Assessment, Development and Evaluation

ILCOR

International Liaison Committee on Resuscitation

IVH

intraventricular hemorrhage

MD

mean difference

NLS

Neonatal Life Support

NNT

number needed to treat

PEEP

positive end-expiratory pressure

PICOST

Population, Intervention, Comparator, Outcome, Study Design and Timeframe

PPV

positive pressure ventilation

PRISMA

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

PROSPERO

Prospective Register of Systematic Reviews

RCT

randomized controlled trial

RD

risk difference

RoB

risk of bias

ROBINS-I

Risk of Bias in Non-Randomized Studies of Interventions

RR

risk ratio

SIB

self-inflating bag

SR

systematic review

TPR

T-piece resuscitator

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: Drs Davis and Schmölzer are coauthors of one study cited in this review; the other 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.

Supplementary data