Best Fed Beginnings: A Nationwide Quality Improvement Initiative to Increase Breastfeeding Available to Purchase

Drs. Bass and Gartley question the premise of our quality report, Best Fed Beginnings: A Nationwide Quality Improvement Intervention to Increase Breastfeeding.1 As a quality report, we describe a quality improvement intervention, and follow the protocols for design and analysis accordingly.2 As such, we did not aim to study the Ten Steps, or 79 specific steps as required by Baby-Friendly USA to achieve designation, in an experimental design. The Best Fed Beginnings (BFB) project was funded and carried out with the understanding and consensus that there was already sufficient evidence to engage in quality improvement necessary to improve maternity care practices in order to support the initiation of exclusive breastfeeding. The Centers for Disease Control and Prevention (CDC) funded the BFB project after assembling the evidence for the Ten Steps.3,4 While steps 3, 5, and 10 are necessary for breastfeeding support, they are not sufficient without the additional steps in supporting the initiation of exclusive breastfeeding.5 Skin to skin care, rooming-in, and avoidance of artificial nipples have been shown to support exclusivity of breastfeeding.6-8 Furthermore, the recommendation of the American Academy of Pediatrics (AAP) is to delay of pacifier introduction until breastfeeding is established.9
The Healthy People 2020 goals for breastfeeding include increased 6-month rates of overall and exclusive breastfeeding, as well as decreased supplementation within the delivery hospital and to increase the percent of newborns delivered in Baby-Friendly designated facilities. As we report, there has been an exponential increase in US newborns delivered at Baby-Friendly designated facilities, exceeding the goal of 8%, but this rate is still below 25%. The table presented by Bass and Gartley is interesting but omits the statewide rates of exclusive breastfeeding. In order to achieve 6 months of exclusive breastfeeding, the time frame recommended by the AAP, initiation of exclusive breastfeeding throughout the delivery hospital is a necessary step. The most significant impact of the BFB intervention was the increase in exclusive breastfeeding.
Safe implementation of the Ten Steps was a priority of the BFB. We conducted webinars and onsite education about safety, appropriate staffing and observation, used process mapping, and reviewed the importance and methods of reporting sentinel events. Lactation support, including trained physicians and staff at all levels of care, were integral to Baby-Friendly designation. Transformative changes, such as the Baby-Friendly Hospital Initiative, require systematic quality improvement processes that begin with small tests of change and safely ramp up to widespread dissemination.

1. Feldman-Winter L, Ustianov J, Anastasio J, et al. Best Fed Beginnings: A Nationwide Quality Improvement Initiative to Increase Breastfeeding. Pediatrics. 2017:e20163121.
2. SQUIRE Team. Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0), September 2015. http://www.squire-statement.org/. Accessed November 6, 2016.
3. Shealy KR, Li R, Benton-Davis S, Grummer-Strawn LM. The CDC guide to breastfeeding interventions. 2005.
4. Grummer-Strawn LM, Shealy KR. Progress in protecting, promoting, and supporting breastfeeding: 1984-2009. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2009;4 Suppl 1:S31-39.
5. Pérez‐Escamilla R, Martinez JL, Segura‐Pérez S. Impact of the Baby‐friendly Hospital Initiative on breastfeeding and child health outcomes: a systematic review. Maternal & child nutrition. 2016.
6. Moore ER, Bergman N, Anderson GC, Medley N. Early skin‐to‐skin contact for mothers and their healthy newborn infants. The Cochrane Library. 2016.
7. Ward LP, Williamson S, Burke S, Crawford-Hemphill R, Thompson AM. Improving Exclusive Breastfeeding in an Urban Academic Hospital. Pediatrics. 2017:e20160344.
8. Buccini GdS, Pérez‐Escamilla R, Paulino LM, Araújo CL, Venancio SI. Pacifier use and interruption of exclusive breastfeeding: Systematic review and meta‐analysis. Maternal & child nutrition. 2016.
9. Moon RY, Darnall RA, Feldman-Winter L, Goodstein MH, Hauck FR. SIDS and Other Sleep-Related Infant Deaths: Updated 2016 Recommendations for a Safe Infant Sleeping Environment TASK FORCE ON SUDDEN INFANT DEATH SYNDROME. PEDIATRICS. 2016;138(5).

The July 2017 report on Best Fed Beginnings by Feldman-Winter et.al. is based on the premise that Baby Friendly (BF) designation and breastfeeding exclusivity on the day of discharge from the birth hospital are appropriate criteria to ascertain the success of hospital support for breastfeeding. Neither breastfeeding rates after discharge nor adverse outcomes are included in the report. The WHO evidence for the Ten Steps, the basis of BF designation, does not provide evidence that all of the 79 specific BF requirements (including 48 arbitrary numerical targets) are necessary or that strict breastfeeding exclusivity in the first days of life is an absolute precondition for subsequent breastfeeding success.¹ It does demonstrate that implementation of steps 3, 5 and 10, which involve lactation support before, during and after hospitalization is effective, a finding confirmed by the recent United States Preventive Services Task Force (USPSTF) report.² While the USPSTF includes evidence that populations with lower educational levels may benefit from BF, no report has ever compared the formal costly and complex BF designation process, with the more straightforward approach of expending the same amount of funding towards expanding hospital lactation services. Of note, data from the 2016 CDC Breastfeeding Report Card demonstrates that states with the highest breastfeeding initiation rates (>90%) more consistently attained the US Healthy People 2020 Breastfeeding Objectives than states with the highest BF rates (>85%) (Table 1). This lack of long-term breastfeeding success is particularly important given the recent attention to certain sentinel events in the newborn. These include newborn falls and sudden unexpected postnatal collapse (SUPC) noted in association with some BF practices by the American Academy of Pediatrics (AAP)³ as well as many other professional organizations worldwide. The unintentional consequences of skin-to-skin care, particularly when practiced unobserved beyond the early hours of life, inadvertent co-bedding resulting from 24 hour rooming-in associated with strict breastfeeding exclusivity required by BF designation, and the ban on pacifier use, are serious risk factors for these sentinel events. ^3,4 As the role of pacifiers in lowering the risk for sudden infant death syndrome is well established,⁵ notifying parents of this fact should have been required by the institutional review board (IRB) rather than granting exempt status to this study. Future IRB decisions about BF research should also take into consideration AAP concerns about newborn falls and SUPC.³ Given the importance of breastfeeding, and the severity of the associated sentinel events, it is critical that government policies promote only those practices that enhance breastfeeding in the safest and most effective manner, encouraging breastfeeding while minimizing risk. The focus should shift from process outcomes such as BF designation, to an objective review of attainment of the Healthy People 2020 Breastfeeding Objectives. Current evidence indicates that to most effectively meet these national goals, hospitals should monitor breastfeeding initiation rates and emphasize provision of lactation support and safe sleep practices throughout the perinatal period.

REFERENCES

1. World Health Organization Division of Child Health and Development. Evidence for the ten steps to successful breastfeeding. Geneva: World Health Organization, 1998.

2. Patnode CD, Henninger ML, Senger CA, Perdue LA, Whitlock EP. Primary care interventions to support breastfeeding: updated evidence report and systematic review for the US Preventative Services Task Force. JAMA. 2016;316:1694-1705 (doi:10.1001/jama.2016.8882).

3. Feldman-Winter L, Goldsmith JP, American Academy of Pediatrics Committee on Fetus and Newborn, Task Force on Sudden Infant Death. Safe sleep and skin-to-skin care in the neonatal period for healthy term newborns. Pediatrics. 2016;138:e20161889 (doi: 10.1542/peds2016-1889).

4. Bass JL, Gartley TG, Kleinman R. Unintended consequences of current breastfeeding initiatives. JAMA Pediatrics 2016;170:923-924 (doi:10.1001/jamapediatrics.2016:1529).

5. Hauck FR, Omojokun OO, Siadaty MS. Do pacifiers reduce the risk of sudden infant death syndrome? A meta-analysis. Pediatrics. 2005;116;e716-e723 (DOI: 10.1542/peds.2004-2631).

Table 1. Healthy People 2020 Breastfeeding Duration Targets

Source: CDC Breastfeeding Report Card 2016

Achieved Target: O

Below Target: X

Dr. Garber et al have questioned the lack of “balancing measures” in our quality improvement intervention, Best Fed Beginnings.1 Their concerns include potential complications related to inadequate breastmilk supply, outpatient breastfeeding rates, “co-sleeping” which we interpret as bed-sharing, and breastfeeding itself.

Increased rates of exclusive breastfeeding in the hospital is a desired outcome of the Baby-Friendly Hospital Initiative (BFHI) and was a desired outcome for the Best Fed Beginnings improvement intervention along with achieving Baby-Friendly designation. There is convincing evidence that breastfeeding rates improve after Baby-Friendly designation.2 As part of the BFB project, we did include patient experience as a balancing measure. These data were captured as part of the Baby-Friendly mother audits and strategically included discussions around patient safety, including bed-sharing and additional newborn outcomes. Hospitals individually used the results of the audits to inform their improvement efforts and to ensure that their processes and system re-designs did not sub-optimize the experiences of mothers. In consideration of reducing the reporting burden to hospitals, hospitals were required to do the audits, report internally, and to only report out qualitatively what they were learning from the results. We agree that it would be interesting for a future collaborative to add balancing measures related to safety that are reported and tracked.
As indicated by a recent Cochrane review by Smith et al3, the World Health Organization’s recommendation of exclusive breastfeeding for the first 6 months of life is supported by the best evidence. Furthermore, this evidence-based review clarified that there is no evidence to support the provision of water or glucose water as a method to prevent hypoglycemia, hypernatremia, or hyperbilirubinemia, and this additional fluid does not support increasing the duration of breastfeeding. The Baby-Friendly Hospital Initiative, as guided by the Ten Steps to Successful Breastfeeding, does not preclude the use of infant formula for medical indications such as newborns who demonstrate a need for enteral feeding when mother’s own milk is unavailable. Thus, deviations from exclusivity for medical reasons are already built into the structure of the intervention. After controlling for socio-demographic variables, evidence supports wide variability between hospitals in exclusive breastfeeding rates at discharge, suggesting that supplementation is often not related to medical indications, and quality improvement efforts such as the BFHI are warranted.4
Finally, it is correct to point out that “co-sleeping” was not reported in this initiative. Co-sleeping is not a measure associated with the BFHI, however, some questions around safe implementation of the Ten Steps in the US have been raised as the number of hospitals gaining Baby-Friendly status has grown exponentially in the US in recent years. Recently, the American Academy of Pediatrics developed a Clinical Report to provide guidance to facilities and practitioners involved in the BFHI.5 Safety should be a key element in implementation of the Ten Steps.

References
1. Feldman-Winter L, Ustianov J, Anastasio J, et al. Best Fed Beginnings: A Nationwide Quality Improvement Initiative to Increase Breastfeeding. Pediatrics. 2017:e20163121.
2. Pérez‐Escamilla R, Martinez JL, Segura‐Pérez S. Impact of the Baby‐friendly Hospital Initiative on breastfeeding and child health outcomes: a systematic review. Maternal & child nutrition. 2016.
3. Smith HA, Becker GE. Early additional food and fluids for healthy breastfed full‐term infants. The Cochrane Library. 2016.
4. Kruse L, Denk CE, Feldman-Winter L, Rotondo FM. Comparing sociodemographic and hospital influences on breastfeeding initiation. Birth (Berkeley, Calif.). 2005;32(2):81-85.
5. Feldman-Winter L, Goldsmith JP, The Task Force on SIDS and Committee on Fetus and Newborn. Safe Sleep and Skin-to-Skin Care in the Neonatal Period for Healthy Term Newborns. Pediatrics. 2016:e20161889.

We read with interest the quality report by Feldman-Winter et al describing their efforts to increase breastfeeding initiation and exclusive breastfeeding rates by helping hospitals achieve Baby-Friendly Hospital Initiative designation (BFHI)1. Not only did they track and improve BFHI, they also tracked and improved rates of overall and exclusive breastfeeding. We applaud their success but note an important omission, a lack of balancing measures. All interventions bring both intended and unintended consequences and quality improvement scientists have the responsibility to track the benefits but also the potential risks of their interventions. Balancing measures are integral to quality improvement, yet we note a lack of balancing measures in this report and in the breastfeeding promotion literature in general, including the US and international papers associated with the BHFI. Candidate measures could include some of the well-described complications that occur when breast milk supply is inadequate, including hypernatremic dehydration and hyperbilirubinemia2, both of which can trigger hospital readmission, and in rare cases, severe morbidity. Additionally, given the results from one large study where breastfeeding rates at 1-month were lower in hospitals with BFHI certification3, and from another small trial where limited amounts of formula supplementation were associated with better long-term breastfeeding success4, outpatient breastfeeding rates would be another useful metric. Evaluating co-sleeping (which is associated with breastfeeding and potential asphyxiation) is another possibility. While the net benefit of breastfeeding is certain, the magnitude of benefit has been questioned by recent cluster randomized trials5, making an objective measurement of potential risks even more important.

1. Feldman-Winter L, Ustianov J, Anastasio J, et al. Best Fed Beginnings: A Nationwide Quality Improvement Initiative to Increase Breastfeeding. Pediatrics. 2017;140(1):e20163121
2. Valerie Flaherman, MD, MPH, Isabelle Von Kohorn, MD, PhD. Interventions Intended to Support Breastfeeding Updated Assessment of Benefits and Harms. JAMA. 2016;316(16)
3. Wendy Brodribb, Sue Kruske, Yvette D. Miller. Baby-Friendly Hospital Accreditation, In-Hospital Care Practices, and Breastfeeding. Pediatrics 2013;131(4).
4. Valerie J. Flaherman, Janelle Aby, Anthony E. Burgos, et al. Effect of Early Limited Formula on Duration and Exclusivity of Breastfeeding in At-Risk Infants: An RCT. Pediatrics. 2013; 131(6).
5. Martin RM, Kramer MS, Patel R et al. Effects of Promoting Long-term, Exclusive Breastfeeding on Adolescent Adiposity, Blood Pressure, and Growth Trajectories: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2017 May 1:e170698.