Breastfeeding Medicine

Physicians blogging about breastfeeding

Evidence is Clear: Baby-Friendly Hospital Initiative Increases Breastfeeding Rates in the US and Closes Breastfeeding Disparities

with 13 comments

By Melissa Bartick, MD, MSc and Nathan Nickel, MPH, PhD

The US Preventative Services Task Force (USPSTF) published its recommendations regarding breastfeeding promotion in the October 25, 2016 issue of JAMA, recommending individual efforts at breastfeeding promotion, but pointedly noting that systemic promotion efforts, such as the Baby-Friendly Hospital Initiative (BFHI), were outside its scope. The accompanying literature review, performed by the USPSTF team, purposely looked only at two trials of BFHI and a few randomized trials of its component Ten Steps, and concluded there was mixed evidence to support BFHI. The two trials they reviewed on BFHI both supported its efficacy, at least in less educated mothers (here and here).  One of the BFHI trials they reviewed was an observational trial, and the other was a before-and-after trial, yet several other US trials with similar methodologies exist which showed positive outcomes, but these were not even mentioned in the  literature review. For example, the literature review did not include this national trial showing a correlation of BFHI with increased breastfeeding rates and excluded national data from the CDC showing rising breastfeeding rates as percentage of live births in Baby-Friendly hospitals rose. The literature review acknowledged that other studies supported the effectiveness of BFHI. However, an accompanying editorial by Flaherman and von Kohorn concluded that interventions such as BFHI “should be reconsidered until good-quality evidence that these interventions are safe and effective.”

Despite the weak literature review, the editorial’s surprising conclusion can in no way be drawn from the evidence presented by the USPSTF, let alone the evidence as a whole. Yet this editorial is what is garnering the most media attention. Interestingly, the editorial does support previous research by one of its authors, Valerie Flaherman, who found that small amounts of formula help women breastfeed longer. This finding, which contradicts previous evidence (here and here) that non-indicated supplemental formula is a strongly associated with breastfeeding failure, would negate Step 6 of the Baby-Friendly Hospital Initiative, “to give no other food or drink besides breast milk without a medical indication.” One of the co-authors of Flaherman’s study disclosed that he worked for several formula companies. Because Flaherman is still conducting similar government-funded research on formula supplementation of breastfed infants, which is incompatible with Baby-Friendly, JAMA should have chosen an editorialist who could be objective about the weight of the evidence on Baby-Friendly as well as include an editorial with an opposing viewpoint in the same publication– especially given the widespread endorsement of the Ten Steps among major US and world medical organizations.

twitter-quote-31The editorial gives readers the impression that there is no robust evidence from randomized control trials on the effectiveness of the Baby-Friendly Hospital Initiative, but we see that this is not true. In addition, literature review notes that they excluded the world’s largest randomized study of Baby-Friendly, PROBIT, published in JAMA in 2001, because it was conducted in Belarus and not in a high-income country. PROBIT, led by Canadian researcher Michael Kramer, included over 17,000 mother-infant pairs and found that exclusive breastfeeding at 3 months went from 6% to 43% in areas where the facilities were randomly assigned to the Baby-Friendly type intervention. What is more important than the income status of Belarus is whether maternity care practices there are similar to those in much of the US. Indeed, PROBIT authors state they chose Belarus rather than North America or Western Europe “because maternity hospital practices in Belarus and other former Soviet republics are similar to those in North America and Western Europe 20 to 30 years ago and thus provide a greater potential contrast between intervention and control study sites. However, Belarus resembles Western developed countries in 1 very important respect: basic health services and sanitary conditions are very similar.” Thus, the effectiveness of Baby-Friendly  is only a question of magnitude. And, notably, many parts of the United States, such as parts of the deep south, arguably still practice maternity care the way it was in the US in the 1970s and 1980’s, contributing to racial and geographic disparities in breastfeeding and health outcomes.

A national survey of US Baby-Friendly hospitals compared to hospitals that were not designated Baby-Friendly, the hospitals designated as Baby-Friendly in 2001 had elevated rates of breastfeeding initiation and exclusivity, regardless of demographic factors that are traditionally linked with low breastfeeding rates. The number of Baby-Friendly practices mothers self-report having received has been shown to correlate with breastfeeding outcome at 6 weeks; and this effect is additive (see references here and here).  Before-and-after studies in an inner city hospital has shown how implementation of BFHI has increased breastfeeding rates among populations with historically low breastfeeding rates, thereby lowering disparities (see here, here and here)

A Cochrane review of randomized trials of skin-to-skin contact, part of BFHI, have shown enhanced breastfeeding status and decrease in hypothermia in late preterm infants, and other studies have found similar effects (here and here). Comparison studies have also been done on rooming in showing positive effects (here, here, and here). By contrast, formula supplementation evidence, for example, is mostly from strong observational studies.

One way to look at the correlation between BFHI, the Ten Steps, and Breastfeeding Rates is to look at national data itself from the CDC Breastfeeding Report Cards and the CDC National Immunization Survey, for the years 2007 to 2013, the years in which we have data on the percentage of births in Baby-Friendly hospitals from the CDC. We can look at the following metrics: the number of Baby-Friendly designated hospitals, the percentage of live births at Baby-Friendly Hospitals, the rate of exclusive breastfeeding at 3 months, and the average national mPINC score. The mPINC is a survey given biannually by the Centers for Disease Control and Prevention to all US maternity facilities ever since 2008. Scored on a 100-point scale, it measures the extent of implementation of the Ten Steps of Successful Breastfeeding that comprise the BFHI. This data show that the mathematical correlation between the increase in births born at Baby-Friendly hospitals and exclusive breastfeeding at 3 months is 0.93, which is extremely high.


It is true that there is a paucity of randomized control trials both on BFHI in the US, and on components of the Ten Steps. One wonders, however: would it be feasible or ethical to conduct further randomized trials of Baby-Friendly at this point? For example, skin to skin contact, breastfeeding within the first hour of life, and keeping baby and mother in close proximity have been found to have numerous beneficial effects on mother and baby. What’s more, non-exclusive breastfeeding itself is a risk factor for SIDS and multiple pediatric infectious diseases. The ethics of randomizing infants to receive non-medically indicated supplements would be problematic, as would the ethics of randomizing hospitals to agree not to pursue Baby-Friendly status. For example, the Ten Steps are endorsed by the American Academy of Pediatrics (AAP),the American College of Obstetricians and Gynecologists (ACOG); hospitals would have to be willing to be randomized to care practices that are not considered the standard of excellence by the AAP, ACOG, the Surgeon General, and the World Health Organization, and this itself may also introduce confounders.

In sum, the best we can do, at this point, is accept those randomized trials we do have, including PROBIT, the strong observational studies, and the before-and-after studies. Together, these offer a compelling picture that Baby-Friendly is an effective means for increasing breastfeeding rates in the post-partum period and beyond. As with any scientific endeavor, we must be open to changing any component of the Ten Steps should further compelling evidence become available.

Melissa Bartick, MD, MSc is an internist at Cambridge Health Alliance and Assistant Professor at Harvard Medical School. You can follow her on Twitter at @MelissaBartick .

Nathan Nickel, PhD is a public health research scientist at the University of Manitoba and Secretary of the Breastfeeding Forum of the American Public Health Association. You can follow him on Twitter at @Nickel_NC .

Posts on this blog reflect the opinions of individual ABM members, not the organization as a whole.


Written by Melissa Bartick, MD, MSc, FABM

November 7, 2016 at 7:38 am

13 Responses

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  1. The Academy of Breastfeeding Medicine is still incapable of addressing the basic patient safety issue of having ZERO evidence that the BFHI protocol is safe for the newborn brain despite the vast array of scientific evidence that newborns made to fast and lose weight while being exclusively colostrum-fed are almost exclusively at greatest risk of brain threatening complications from starvation including the 10% of healthy term EBF Babies who become hypoglycemic by 6 hour that undergo the BFHI protocol, the 14% of babies who become dehydrated and the 10-18% who experience starvation-related jaundice as cited by your own protocols that are NOT experienced by supplemented and formula-fed newborns. They fail to address the patient rights violation of failing to inform mothers of the risks of NOT supplementing including the risk of irreversible brain injury and disability from hypernatremia, dehydration, hypoglycemia and severe jaundice caused by starvation. Every day the human rights of newborns are violated in baby-friendly hospitals when they are left to cry without supplementation, lovingly known as “the second night syndrome” because they are, in fact, fasting, hungry and sometimes actually starving. Their mothers are bullied and shamed and formula is hidden from them until their babies suffer complications. The BFHI deserves to be dismantled and to be prosecuted for the millions of babies it has hospitalized that would not have been had their mothers been told the truth about newborn starvation from exclusive colostrum feeding and had they been allowed to follow their instincts regarding their newborn’s need for food. I hope your organization gets prosecuted with it.


    November 7, 2016 at 9:07 am

  2. Yes, a modern baby-friendly hospital will support breastfeeding better than the typical US hospital did 40 years ago, but that’s an irrelevant question. The important question is, do all 10 steps matter? For example, Step 5, show mothers how to breastfeed, is clearly going to improve breastfeeding success and has no plausible harms. Step 8, encourage breastfeeding on demand, is also a great idea.

    There are two steps, however, which are more controversial, steps 6 and 9. Giving no food or drink other than breastmilk unless medically indicated may increase the number of newborns who become ill from insufficient intake, and that number is already too high. Breastfeeding good, fear of supplementing bad.

    As for Step 9, there is no evidence that pacifiers interfere with breastfeeding, and good evidence that pacifiers decrease the risk of SIDS, which means forbidding pacifiers may not be a good idea.

    The BFHI is 25 years old, and in those 25 years, mountains of research on breastfeeding have been published. Why is it so vital to defend BFHI exactly as it was written, rather than revising the guidelines on the basis of the latest research?

    Brooke Orosz

    November 7, 2016 at 9:18 am

  3. Talk about an oxymoron! Encouraging mothers to breastfeed their babies is now being called an “intervention” by doctors, even though breastfeeding is best for babies and mothers. Just more evidence that doctors are not well informed, and are not helping mothers and babies. I suppose they are calling it an intervention because actually encouraging mothers to breastfeed is still a new concept to doctors, so they view it as an intervention?

    Cassandra Cross

    November 7, 2016 at 10:44 am

  4. The rate of breastfeeding was rising dramatically before the BFHI ever existed. That the rate has continued to rise is meaningless. It does not show that the BFHI had anything to with the rise at all.

    What about the fact that the BFHI bans pacifiers despite scientific evidence that shows that pacifiers prevent SIDS?

    You ignore that.

    What about the scientific evidence that enforced prolonged skin to skin contact leads to infant smothering deaths?

    You ignore that.

    What about the scientific evidence that mandatory rooming in policies and closing well baby nurseries leads to infant deaths from skull fractures and smothering?

    You ignore that.

    The bottom line is pretty simple:

    I and others can demonstrate literally hundreds, perhaps thousands, of infant injuries and deaths as a result of the BFHI. In contrast, you offer not even a single term baby whose life has been saved by the BFHI.

    The BFHI is a deadly failure. It’s time to end it.

    Amy Tuteur, MD

    November 7, 2016 at 10:49 am

  5. Wow. So feeding babies in the physiologically normal way is somehow forced starvation? This is such a backwards way of thinking. Adding formula to the mix is the intervention, so before you advocate for it, you need to prove there are no negative consequences to introducing formula to newborns. What happens to the gut microbiome when newborns are given formula is extremely troubling. If a baby given unrestricted access to the breast is really crying from hunger, help the mother hand-express. The main problem isn’t that formula is withheld, it’s that hospital practices interfere with mother-baby togetherness. Baby-Friendly has nothing to do with letting babies cry unattended and unfed.


    November 7, 2016 at 10:53 am

    • What exactly ‘happens to the gut microbiome when formula is introduced’?

      Anne Risch

      November 28, 2016 at 8:41 am

  6. Well, that’s a lot of non-scientific vitriol that leaves intact Dr. Bartick’s arguments.
    Missing is any kind of research citation, but especially notable are two things:
    1. How do you weigh the “benefits” of artificial nipples against the harm done to breastfeeding success? Or skin-to-skin? Similarly, I see no rational discussion of risks/benefits of any of the items that the commenters seem to think discount the BFHI. (Sounds like an agenda to me.)
    2. Anything can be done wrong. Any of the BFHI steps can be done poorly or improperly, with bad results. For instance, no competent health professional would miss the signs of dehydration or hypoglycemia and see the need for supplementation. Bed-sharing can be done wrong.

    Can we not have a forthright, rational, scientifically-based conversation, without agenda? I suspect professional development and BFHI competence is the answer to the purported harms. I am amazed that competent professionals are still demanding evidence that breastfeeding is important to the health of babies.


    November 7, 2016 at 11:29 am

    • If no competent professional would miss the signs of dehydration, why is it that tens of thousands of American babies who are healthy at birth need to be admitted to intensive care due to insufficient breast milk intake? Occasional mistakes may be unavoidable, but if it’s happening this often, there’s something wrong at the system level.

      Where is the evidence that pacifiers interfere with breastfeeding? There is none. Babies even at birth know the difference between a nipple that gives milk and one that does not. And the benefit is a reduction in the risk of SIDS, the leading cause of death among babies who are healthy at birth.

      The question is not whether we should support breastfeeding, but whether the BFHI in its current form is the most effective and safest way to support breastfeeding. I say it needs revision. Keep providing lactation support, keep providing post-discharge follow-up, but bring back pacifiers and make sure that exhausted mothers have the option of sending baby to the nursery if necessary. In addition, revise the guidelines on when to supplement, with a specific goal of reducing NICU admission and hospital readmission for complications of insufficient intake.

      Everything in medicine gets revised as more evidence becomes available. The chemotherapy protocols from 25 years ago are horrifying by modern standards, for example. Why not update the BFHI guidelines based on the latest evidence?

      Brooke Orosz

      November 7, 2016 at 7:08 pm

      • Tens of thousands? Citation, please.
        Babies at birth know the difference between sucking on an artificial and human nipple? (Not just whether it yields a liquid, but the physiological differences of sucking the two.) Citation, please.
        When to supplement? I believe they are in place based on a percentage of birthweight lost (taking into account added fluids from an IV). What others would you suggest?
        Of course hospital staff should listen when a mother doesn’t want her baby in her room with her.
        Of course, consider new evidence. When there is evidence.

        Marguerite Herman

        November 9, 2016 at 11:00 am

    • Well said! I could not agree with you more!


      November 10, 2016 at 12:22 pm

  7. I sure wish Dr. Amy Tuteur was on your mailing list. She is in great need of updated education and information….. Sigh.

    Jeanne Batacan

    November 7, 2016 at 1:59 pm

  8. […] Academy of Breastfeeding Medicine, Evidence is Clear: Baby-Friendly Hospital Initiative Increases Breastfeeding Rates in the US and Clo… […]

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