Baby-Friendly Hospital Initiative Is Associated with Lower Rates of Neonatal Hyperbilirubinemia

Abstract

Background:

The Baby-Friendly Hospital Initiative (BFHI) advances practices that support exclusive breastfeeding. BFHI practices are associated with increased breastfeeding rates, however, other patient outcomes are not well described. This study examined the association of BFHI practices with hyperbilirubinemia and phototherapy between groups of newborns born before and after BFHI implementation at an urban, tertiary academic medical center in South Carolina.

Materials and Methods:

We conducted a retrospective study of healthy, term newborns born between July and September 2011 (n = 956), before BFHI implementation, and newborns born during the same period in 2013 (n = 1,131) after BFHI implementation. Primary outcomes were neonatal hyperbilirubinemia, phototherapy treatment, and hospital readmissions for hyperbilirubinemia within 30 days of discharge. We compared rates of outcomes between the study groups using unadjusted and adjusted odds ratios (OR).

Results:

Among newborns born before versus after BFHI implementation, 20.3% versus 6.98% were diagnosed with hyperbilirubinemia (p < 0.001), 5.75% versus 1.95% received phototherapy (p < 0.001), and 0.31% versus 0.35% were readmitted to the hospital for hyperbilirubinemia within 30 days (p = 0.88). In adjusted analyses, newborns born after BFHI implementation were significantly less likely to develop neonatal hyperbilirubinemia (OR 0.28 [95% confidence intervals; CI 0.20–0.37]) and receive phototherapy treatment (OR 0.27 [95% CI 0.15–0.49]) than newborns born before BFHI implementation.

Conclusions:

Implementation of BFHI practices is associated with significant decreases in neonatal hyperbilirubinemia and phototherapy without affecting readmission rates. Exclusive breastfeeding has traditionally been considered a risk factor for the development of neonatal jaundice. This study demonstrates that BFHI practices may mitigate that risk.

Introduction

The benefits of exclusive breastfeeding over formula feeding are well documented.^1–3 Health benefits reported in the medical literature include lower rates of minor, major, acute, and chronic health problems for infants and children and additional health benefits for breastfeeding mothers.^1,3 However, average annual exclusive breastfeeding rates in the United States are suboptimal, or consistently fall below medical recommendations, which has led to excess health care costs and preventable maternal and child deaths across the United States.^4,5

Investing in strategies to promote and optimize exclusive breastfeeding would benefit US health care on both an individual and national level. One such strategy is the Baby-Friendly Hospital Initiative (BFHI), a global program created by the World Health Organization (WHO) and United Nations Children's Fund (UNICEF) to promote and support exclusive breastfeeding through the first 6 months of life.^6,7 Baby-Friendly USA, the accrediting body for the BFHI in the United States, uses rigorous and data-driven criteria to designate birth facilities as “Baby-Friendly” based on their successful implementation of the Ten Steps to Successful Breastfeeding (Fig. 1). As of 2018, more than 500 US birth facilities had achieved formal Baby-Friendly designation and more than five million babies have been born in Baby-Friendly hospitals.⁸

FIG. 1.

The Ten Steps to Successful Breastfeeding form the basis of the Baby-Friendly Hospital Initiative. Baby-Friendly facilities uphold the International Code of Marketing of Breast Milk Substitutes by promoting human milk rather than substitutes.

While exclusive breastfeeding is considered the gold standard for infant nutrition, a reported negative health outcome associated with the practice is the risk for development of neonatal hyperbilirubinemia,^9–13 a common medical condition reported in healthy US newborns.⁹ Several studies have reported associations between breastfeeding and increased incidence and severity of indirect hyperbilirubinemia.^14–17 Breastfeeding is also associated with prolonged unconjugated hyperbilirubinemia, or jaundice persisting past 14 days of life, although this generally resolves on its own without breastfeeding discontinuation.¹⁸ In the extreme, hyperbilirubinemia may lead to kernicterus, a form of brain damage linked to jaundice, which has been the focus of several health care initiatives in the last decade.^{9,12,13,19–22} Less attention, however, has been given to addressing the underlying risk factors reported to contribute to hyperbilirubinemia, since a majority of these are demographic in nature.

Breastfeeding does not result in increased bilirubin production.²³ Rather, due to suboptimal lactation or inadequate milk transfer, breastfed infants may experience caloric deprivation and consequent increased enterohepatic circulation or delayed passage of meconium, which may also increase intestinal bilirubin absorption.¹⁸ When optimal breastfeeding is established, peak bilirubin levels of breastfed infants are not greater than those of formula-fed infants.²³ Prior studies have found a relationship between bilirubin levels and weight loss such that breastfed infants with hyperbilirubinemia have significantly lower body weight than breastfed infants without the condition.^24,25 These studies support the theory that neonatal jaundice in breastfed infants occurs in the presence of inadequate caloric intake and that breastfed infants are at no greater risk for the development of hyperbilirubinemia than formula-fed infants when adequate breastfeeding is in place.

Due to the positive impact of the BFHI on exclusive breastfeeding initiation and duration,^26–28 and infant weight loss,²⁹ it is reasonable to assume that the BFHI improves breastfeeding adequacy and therefore lowers the risk of hyperbilirubinemia in newborns. The goal of this study was to determine whether BFHI implementation at a single hospital center was associated with reduced rates of hyperbilirubinemia and associated treatment outcomes in a newborn population. Based on clinical observation, we hypothesized that newborns born after BFHI implementation would have lower rates of neonatal hyperbilirubinemia and phototherapy treatment than newborns born before BFHI implementation.

Materials and Methods

Study design, setting, and population

A retrospective cohort study was conducted at Greenville Memorial Hospital (GMH), a 995-bed tertiary referral hospital and academic medical center in Upstate South Carolina. This facility, which delivered nearly 5,500 babies per year during the study period, has the largest labor and delivery unit in Upstate South Carolina. Our study population consisted of healthy newborns consecutively born at GMH from July 2011 to September 2011 and from July 2013 to September 2013. Newborns with a gestational age under 35 completed weeks or those with admission to a neonatal higher level of care were excluded from the study. The first quarter representing full BFHI implementation at GMH was identified as July to September 2013, thus newborns born during this period comprised the postimplementation group. The comparison (preimplementation) group was determined by selecting newborns born in the same calendar quarter before implementation of any of the BFHI Ten Steps, which was identified as July to September 2011. The Greenville (now Prisma) Health System Institutional Review Board approved this study.

Data collection and definitions

To obtain outcome variables, our Quality Management department provided a list of all newborn charts reflecting a diagnosis of neonatal hyperbilirubinemia and phototherapy in both quarters, using International Classification of Disease, Ninth Revision, Clinical Modification³⁰ (ICD-9-CM) codes 774.6 (unspecified fetal/neonatal jaundice) and 99.83 (other phototherapy), respectively. We also requested records of infants who were born in the study period and readmitted to the hospital within 30 days. Next, hospital staff experienced in medical record data abstraction performed a chart review to obtain first bilirubin zone and maximum bilirubin zone for all infants. Bilirubin zones were determined by total serum bilirubin (TSB) measurements plotted on the American Academy of Pediatrics' age-specific bilirubin risk nomogram published in 2004.^9,12 We defined neonatal hyperbilirubinemia as TSB at or above the 75th percentile (i.e., high-risk and high intermediate-risk zones) for age in hours using the risk nomogram.^9,12 Readmission cases were reviewed to confirm that medically indicated treatment of hyperbilirubinemia was the primary reason for admission.⁹

Based on hospital protocol, all newborns were screened with fractionated and TSB for high intermediate risk transcutaneous bilirubin results, either at onset of clinical jaundice or on the morning of discharge, whichever comes first. During both study periods, TSB (unconjugated and conjugated bilirubin) for any child younger than 30 days old was assayed in the hospital's neonatal intensive care unit (NICU) laboratory. All bilirubin testing in the NICU laboratory was performed according to the manufacturer's instructions on a Vitros 250 analyzer (Ortho Clinical Diagnostics, Rochester, NY) using BuBc Slides. A 2012 Food and Drug Administration recall³¹ of Ortho Clinical Diagnostics calibration diskettes and certain BUBC slide lots did not affect our testing equipment. Specimens were stored at room temperature and tested within 30 minutes of data collection.

Traditional risk factors for hyperbilirubinemia were selected as covariates in this study. Maternal age and race, infant gender, gestational age, and delivery mode were requested from electronic birth certificate data. Gestational age for each newborn was determined by antenatal dating methods and confirmed by Ballard assessment if under 37 weeks' gestation, multiple gestation, or with inadequate prenatal care. We defined newborns between 35 and 37 weeks' completed gestation at birth as late preterm. Covariates abstracted via chart review included newborn feeding methods (exclusively breastfed, exclusively formula fed, or mixed feeding), birthweight, and postnatal weight before discharge. We defined excess weight loss as 90th percentile or greater weight loss for age in hours using the Newborn Weight Tool (NEWT) early weight loss nomograms.^32,33 Covariates abstracted from ICD-9-CM diagnosis codes included maternal pregestational diabetes (250 and 648.0x), newborn cephalohematoma (767.19), polycythemia (776.4), and ABO-Rh incompatibility (773.0–773.2).

Statistical analysis

Maternal and infant characteristics for newborns born in the BFHI pre- and postimplementation periods were compared using chi-squared tests for categorical data. Results are presented as the number and percentage of observations in each category, along with the p value based on the chi-squared test. Logistic regression models were used to compare the rates of neonatal hyperbilirubinemia, phototherapy, and 30-day hospital readmissions before and after BFHI implementation. Results are presented as odds ratios (OR) and corresponding 95% confidence intervals (CI). In adjusted models, all a priori covariates were individually forced into the models and retained if they were significant at p < 0.05 or if there was evidence of confounding (i.e., changed parameter estimates by at least 10%). Final models were adjusted for feeding type, gestational age, and ABO-Rh incompatibility. In addition, we assessed for effect modification by feeding type. A small percentage of data was missing for feeding method (2.59%). Sensitivity analyses based on multiple imputation did not alter any of the results presented here. In further sensitivity analyses, we constructed multivariable logistic regression models using the firth estimation method to handle sparse data.³⁴ Data were analyzed using SAS software, version 9.4 (SAS Institute, Inc., Cary, NC). Two-sided p values <0.05 were considered statistically significant.

Results

A total of 956 newborns were born in the BFHI preimplementation period and 1,131 during the postimplementation period. Demographics of the newborn population during the two study periods were similar with respect to maternal race and pregestational diabetes (Table 1). Significant differences were seen with respect to maternal age (p < 0.001), where the percentage of newborns born to younger mothers tended to decrease between study periods. Newborn characteristics were similar in both groups with three exceptions. Newborns born in the postimplementation period were significantly less likely than newborns born in the preimplementation period to have a diagnosis of cephalohematoma (0.88% versus 2.62%, p < 0.01) or polycythemia (1.06% versus 2.72%, p < 0.01). However, newborns born the postimplementation period were more likely to have ABO-Rh incompatibility (1.77% versus 0.52%, p < 0.01) than newborns born in the preimplementation period. During the quarters studied, the proportion of exclusively breastfed newborns increased from 29.9% in 2011 to 58.9% in 2013 (Fig. 2), while the percentage of newborns who received exclusive formula-feeding or mixed feeding decreased from 30.7% to 24.8% and from 39.3% to 16.3%, respectively.

FIG. 2.

Newborn feeding practices at Greenville Memorial Hospital before and after Baby-Friendly implementation. p-Value, which was obtained using chi-square (χ²) tests for categorical variables, is significant at p < 0.001.

Table 1.

Characteristics of Newborns Born Before and After Baby-Friendly Hospital Initiative Implementation, 2011 and 2013 (N = 2,087)

	Preimplementation, 2011 (n = 956)		Postimplementation, 2013 (n = 1,131)
Characteristics	n	%	n	%	p^a
Maternal
Age (years)					0.001
<18	24	2.51	13	1.15
18–24	300	31.4	280	24.8
25–34	501	52.4	661	58.4
≥35	131	13.7	177	15.6
Race/ethnicity					0.18
Non-Hispanic white	582	60.9	722	63.8
Non-Hispanic black	185	19.4	222	19.6
Hispanic/Latino	164	17.2	155	13.7
Other non-Hispanic	25	2.62	32	2.83
Prepregnancy diabetes	6	0.63	14	0.67	0.15
Newborn
Female sex	485	50.7	590	52.2	0.51
Gestational age (weeks)					0.12
35 0/7–37 6/7	168	17.6	170	15.0
≥38 0/7	788	82.4	961	85.0
Mode of delivery					0.36
Vaginal	671	70.2	773	68.4
Cesarean	285	29.8	358	31.7
Birth weight (g)					0.24
<2,500	53	5.54	50	4.42
≥2,500	903	94.5	1,081	95.6
Excess weight loss^b	58	6.07	64	5.66	0.69
Cephalohematoma	25	2.62	10	0.88	<0.01
Polycythemia	26	2.72	12	1.06	<0.01
ABO-Rh incompatibility	5	0.52	20	1.77	<0.01

p-Values obtained using chi-square (χ²) tests for categorical variables. p Values significant at p < 0.05.

Defined as 90th percentile or greater weight loss for age in hours using the Newborn Weight Tool (NEWT) early weight loss nomograms.

The proportion of newborns with neonatal hyperbilirubinemia declined from 20.3% before BFHI implementation to 6.98% after implementation (p < 0.001) (Table 2). The proportion of newborns treated with phototherapy declined from 5.75% before implementation to 1.95% after implementation (p < 0.001). The proportion of newborns who were readmitted to the hospital for hyperbilirubinema within 30 days of discharge was ∼0.30% in both periods (p = 0.88). In adjusted analyses, newborns born after BFHI implementation were significantly less likely to develop neonatal hyperbilirubinemia (adjusted OR 0.28 [95% CI 0.20–0.37]) or be treated with phototherapy (adjusted OR 0.27 [95% CI 0.15–0.49]) than those born in the preimplementation period. There was no significant association between BFHI and hospital readmissions for hyperbilirubinemia within 30 days of discharge from the birth hospitalization (adjusted OR 1.36 [95% CI 0.28–6.65]). Moreover, there was no suggestion of effect modification by any of the maternal or newborn characteristics (data not shown). Multivariable models based on the firth estimation method produced similar results as the main analyses (Supplementary Table S1).

Table 2.

Rates of Neonatal Hyperbilirubinemia and Phototherapy Use in Newborns Before and After Baby-Friendly Hospital Initiative Implementation, 2011 and 2013 (N = 2,087)

Outcomes	Preimplementation, 2011 (n = 956)		Postimplementation, 2013 (n = 1,131)		p^a	Unadjusted		Adjusted^b
Outcomes	n	%	n	%	p^a	OR	95% CI	OR	95% CI
Neonatal hyperbilirubinemia^c	194	20.3	79	6.98	<0.001	0.30	0.22–0.39	0.28	0.20–0.37
Phototherapy^d	55	5.75	22	1.95	<0.001	0.33	0.20–0.54	0.27	0.15–0.49
Hospital readmissions for hyperbilirubinemia within 30 days	3	0.31	4	0.35	0.88	1.13	0.25–5.05	1.36	0.28–6.65

p-Values obtained using chi-square (χ²) tests for categorical variables. p-values significant at p < 0.05.

Adjusted for feeding method, gestational age, and ABO-Rh incompatibility (773.0–773.2).

Defined as total serum bilirubin at or above the 75th percentile (i.e., high-risk and high intermediate-risk zones) for age in hours using hour-specific bilirubin nomograms recommended by the American Academy of Pediatrics.

ICD-9-CM code 99.83.

CI, confidence interval; OR, odds ratio.

Discussion

Although the gold standard for infant nutrition, exclusive breastfeeding has traditionally been considered a risk factor for the development of neonatal indirect hyperbilirubinemia.^9–13 Current guidelines for the management of neonatal hyperbilirubinemia include the recommendation that hospitals promote and support successful breastfeeding,^1–3,9–13 acknowledging that inadequate milk intake during breastfeeding may contribute to the development of hyperbilirubinemia.^35–37 This study found that implementation of BFHI in a single hospital center was significantly associated with reduced rates of neonatal hyperbilirubinemia and phototherapy treatment among newborns, without increased rates of 30-day hospital readmissions for the treatment of hyperbilirubinemia. To our knowledge, this is the first study in the United States to have examined this association.

Our observed reduction in rates of hyperbilirubinemia and use of phototherapy in a newborn population with high rates of exclusive breastfeeding supports the theory that feeding-related risk for developing hyperbilirubinemia is not necessarily due to feeding method or milk type but feeding adequacy. When BFHI practices are in place, newborns are more likely to achieve early and effective exclusive breastfeeding.^6,7,38,39 Our data suggest that the BFHI is an effective primary prevention strategy for reducing rates of neonatal hyperbilirubinemia and phototherapy use in exclusively breastfed newborns. Additional studies are needed to evaluate whether hyperbilirubinemia and phototherapy outcomes improve with greater participation in the BFHI Ten Steps, as previous studies indicate that breastfeeding outcomes improve in a dose–response manner as facilities implement additional Baby-Friendly practices.^26,40,41

This study also examined 30-day hospital readmissions for hyperbilirubinemia as an important balancing measure. By examining this outcome, we sought to determine whether Baby-Friendly practices might be protective against early hyperbilirubinemia but then lead to new problems after discharge, since bilirubin levels are known to increase during the first week after birth. Our data suggest that Baby-Friendly practices may not protect against nor exacerbate readmissions for hyperbilirubinemia. However, because absolute readmission numbers during the quarters studied were small, further studies with larger sample sizes are warranted to draw conclusions about the impact of BFHI practices on long-term health care utilization and medical outcomes.

The Development Phase of the Baby-Friendly pathway was initiated at our hospital facility in July of 2012, as part of the Best Fed Beginnings collaborative project sponsored by the Centers for Disease Control Prevention and National Institute for Children's Health Quality. Full implementation of the Ten Steps to Successful Breastfeeding was achieved by July of 2013. In this study, BFHI implementation in our institution was associated with a significant increase in overall rates of exclusive breastfeeding, which is consistent with previous studies.^26–28 Contrary to previous research,⁴² infants in our sample were similar with regard to weight loss before and after BFHI implementation.

The quality and efficacy of breastfeeding support in US birth hospitals varies widely, but those designated Baby-Friendly are considered to have demonstrated the highest standards of care in newborn feeding practices through evidence-based methods.⁸ The formal Baby-Friendly assessment process requires that facilities provide detailed evidence through self-assessment and data collection of compliance with the Ten Steps to Successful Breastfeeding outlined by BFHI,⁸ as well as compliance with the World Health Organization's (WHO) International Code of Marketing of Breast Milk Substitutes.⁴³ Facilities must also invite evaluators to observe the hospital environment, maternity, and infant care processes and interview mothers about the birth experience. Because of the degree of difficulty associated with achieving designation, some states and breastfeeding support organizations have developed alternative programs⁷ that recognize hospitals for taking steps to support and promote breastfeeding, but comparative effectiveness of these less rigorous programs have not been widely researched or reported. If the results of this study are validated, then 100% participation in the BFHI may confer the potential for the ∼4 million annual US births to have the added benefit of a lower risk of developing hyperbilirubinemia. In the interim, the cascade of negative effects associated with neonatal hyperbilirubinemia can be considered yet another burden of suboptimal breastfeeding, currently estimated to cost society $17.2 billion annually.⁵

These results have important clinical implications. It is recommended that every newborn with a discharge total bilirubin level at or above the 75th percentile have additional testing performed within 24–48 hours, depending on risk factors.¹² Serum bilirubin testing is painful, and additional testing by any method is stressful for the newborn and has the potential to disrupt breastfeeding and add to health care costs. If hyperbilirubinemia progresses to the degree that requires phototherapy, then complications of phototherapy, such as over- or underheating, insensible water loss, dehydration, increased crying, and caloric expenditure, must be addressed when they occur, further increasing stress, cost, and breastfeeding disruption.^13,44 In addition, parents of newborns diagnosed with or treated for hyperbilirubinemia have been found to access medical care services at higher rates.^45–47 Finally, since hyperbilirubinemia has been linked to ineffective breastfeeding, the diagnosis often leads to reduced confidence in breastfeeding, which may increase rates of supplementation and early discontinuation.

Our analysis has several limitations. First, this study cannot determine which of the Ten Steps to Successful Breastfeeding are responsible for the observed outcomes. Second, medical diagnoses for certain medical conditions, such as cephalohematoma, were derived from clinician judgment without independent expert validation. Third, because of the observational before-and-after study design, our study has the potential for confounding, and other factors not measured in this study may be partially responsible for the observed reductions in hyperbilirubinemia and phototherapy rates between periods. Future research is needed to examine the association of BFHI with study outcomes using a more robust observational design, such as an interrupted time-series design or differences-in-differences estimation. Fourth, our data were abstracted from a tertiary academic hospital in the Southeastern United States with a large delivery volume of infants, which may limit the generalizability of these findings to other institutions.

Conclusion

Current strategies to prevent neonatal hyperbilirubinemia are limited to nonspecific recommendations related to breastfeeding promotion and support and rigorous attention to screening and follow-up programs.^9,12,45 The specific methods outlined to support breastfeeding in the AAP 2004 Hyperbilirubinemia guidelines are limited to promoting nursing frequency (8–12 times/day) and “providing appropriate support and advice.”⁹ An update and clarification of the guideline in 2009 added a recommendation to ensure early follow-up (within 2 days) for infants discharged before 72 hours of age.¹² Our data suggest that a previously unexplored approach for preventing neonatal hyperbilirubinemia may be to promote the BFHI as an effective primary prevention strategy. The demonstration of a positive association between BHFI practices and patient outcomes beyond breastfeeding rates is important for further promotion and expansion of the BFHI. This research additionally points to the importance of exclusive breastfeeding initiatives for the overall health and well-being of future US newborns.

Footnotes

Acknowledgments

The authors thank Eric Schafer for providing Newborn Weight Tool percentiles for this study. We also thank Jeanne-Marie Allred and Dawn Blackhurst for data support, Drs. Reese Clark and Ben Sharp for statistical review, and Robert Saul, Jon Markowitz, and Ally Hale for review of the article.

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

Supplementary Material

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Supplementary Material

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