JAMA review questions the safety and effectiveness of the Baby Friendly Hospital Initiative

(Un)Safe - New chalkboard with 3D outlined text

Last week I noted that the editor of premier breastfeeding journal declared that it is time for a critical review of the Baby Friendly Hospital Initiative and its Ten Steps.

The editor’s key point:

What is needed in my opinion is not a rigid categorical defense of a magic (holy?) 10 but an intellectually rigid evaluation of the individual steps and their possible various combinations (not necessarily of all 10) that are both safe and efficacious.

Perhaps he was thinking about a new evaluation of the BFHI guidelines that was just published in the Journal of the American Medical Association. The JAMA Network has produced a Clinical Guideline Synopsis of World Health Organization Baby-Friendly Hospital Initiative Guideline and 2018 Implementation Guidance.

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]The review is couched in careful language, the conclusions devastating: the BFHI ignores the scientific evidence, risks babies’ lives and isn’t even particularly effective.[/pullquote]

The review notes three major revisions in the evidence guidelines [EG]:

1. Recommendations around skin to skin care

The benefit of early skin-to-skin care (SSC) for glucose homeostasis (blood glucose level at 75-100 minutes after birth: meaningful difference, 10.49 mg/dL … 95% CI, 8.39-12.59), thermoregulation (a slight increase in axillary temperature at 90-150 minutes after birth: meaningful difference, 0.30°C; 95% CI, 0.13-0.47), and any breastfeeding at age 1 to 4 months (relative risk [RR], 1.24; 95% CI, 1.07-1.43) was cited. The EG recognizes the potential for sudden infant collapse during unobserved SSC in the first 2 hours of life, citing rates of 1.6 to 5 cases per 100 000 live births with mortality rates of 0 to 1.1 per 100000 livebirths. This is addressed by a recommendation for close observation for at least the first 2 hours after delivery coupled with vigilance to assess and manage signs of distress and prevent the infant from being hurt unintentionally.

Previous BFHI guidelines recommended continuing the practice of SSC throughout the hospital stay while rooming-in. As there are no studies that specifically demonstrate that SSC confers benefits beyond the early hours of life in term newborns, this practice, when coupled with rigid compliance with breastfeeding exclusivity, has raised safety concerns about unmonitored SSC, particularly overnight by an exhausted or sedated mother. The new guideline focuses on immediate (within 10 minutes of birth) and early SSC (10 minutes-23 hours) without explicitly advocating for ongoing SSC beyond that time. It notes the need for safety vigilance during SSC and that hospital resources may be inadequate to safely perform the task beyond the immediate period. The EG also notes that while there are many benefits to rooming-in, many mothers prefer not to and rooming-in “probably makes little to no difference to any breastfeeding at 6 months”.

Take home messages:

  • There is no evidence of benefit of skin-to-skin in term babies beyond the early hours.
  • Even those benefits are trivial.
  • Unmonitored SSC increases the risk of neonatal death.
  • Rooming in makes essentially no difference to breastfeeding at 6 months.

2. Formula supplementation

While supportive of breastfeeding exclusivity, the IG [Implementation Guidance] recognizes that supplementation may be necessary for some infants because of inadequate milk supply and maternal choice. The IG mentions the need for vigilance for the risk for late preterm newborns of jaundice, hypoglycemia, and feeding problems. The EG also cites a Cochrane review of randomized controlled trials demonstrating that “addition of artificial milk in the first few days after birth probably makes little or no difference to the success and duration of breastfeeding at discharge” (RR, 1.02; 95% CI, 0.97-1.08) and the IG national monitoring definition of exclusive breastfeeding is now receiving “only breastmilk during the previous day.” A recommendation was also added to provide donor milk to healthy full-term newborns who required supplementation without providing cost-benefit evidence to support this practice in term infants.

Take home messages:

  • Formula use may be necessary because of inadequate milk supply.
  • There is no evidence that judicious formula use in the first few days has any impact on breastfeeding.
  • There is no evidence to support a recommendation of donor breast milk for term infants.

3. Pacifier use

Consistent with evidence that pacifiers reduce the risk of sudden infant death syndrome (SIDS) and high-QOE that pacifiers do not interfere with breastfeeding outcomes, the draft IG had pro- posed eliminating pacifier restrictions. Despite evidence that mothers value using pacifiers, this change was not included in the final IG. Instead, advice to counsel mothers about hygiene risks was added without mentioning the reduced risk of SIDS associated with pacifier use.

Take home messages:

  • Pacifiers prevent SIDS.
  • Pacifiers do not interfere with breastfeeding.
  • The new guidance ignores this scientific evidence.

The authors note that the BFHI is not the only way or even the best way to support breastfeeding:

Institutional and public health clinicians should consider using the EG to develop their own policies whenever a specific recommendation in the IG is inconsistent with evidence or does not seem applicable to local circumstances.

A notable shift of emphasis that will foster local innovation is the IG conclusion that BFHI designation is not the only worthy public policy option for breast feeding support. Consistent with the US Preventative Services Task Force evidence report, the draft for public comment stated “While the designation of baby-friendly is one way to recognize facilities that provide appropriate care, designation is not the most effective strategy to achieve sustainable improvement in the quality of maternity care.”

Though the review is couched in careful language, the conclusions are devastating: the BFHI ignores the scientific evidence, risks babies’ lives and isn’t even particularly effective.