Is Formula More Dangerous than Irreversible Brain Damage?

Is that some kind of sick joke? Infant formula is safe nutrition—scientifically created to replace human milk and thus consists of fluids and nutrients necessary to nourish a baby. Brain damage is irreversible.  That should be glaringly obvious, but it looks like the AAP Breastfeeding Section responsible for the recently released “Breastfeeding and the Use of Human Milk” (June 2022) has lost sight of this critical fact.

Let’s focus on this appalling statement:

“The need for phototherapy in an otherwise healthy infant without signs of dehydration and/or insufficient intake is not an indication for supplementation with formula unless the levels are approaching exchange transfusion levels.”

Hyperbilirubinemia (excessive jaundice) and Phototherapy

To explain why we are horrified, let’s look carefully at what the statement means. Jaundice is a common and usually benign condition experienced by about 60% of healthy newborns. It is caused by a substance called bilirubin, a breakdown product of fetal red blood cells after birth to transition to mature red blood cells. However, if a baby’s bilirubin levels are greater than a certain level and continue to climb, the risk for brain damage increases.

 

 

A baby should never be allowed to experience a dangerous bilirubin level, and all interventions should be utilized to bring the levels down quickly!

 

There is, however, a cost-effective preventable intervention available—it’s called adequate feeding of donor milk or infant formula with a bottle which is the absolute BEST way to reduce bilirubin levels. It also provides comfort for a baby who is lethargic, hungry, thirsty and has dry, chapped lips and mouth. Multiple blood checks will also be necessary to monitor bilirubin levels, which are painful for newborns.

To be clear, supplementation does NOT interfere with exclusive breastfeeding.  Exclusive breastfeeding can be resumed when the full milk supply has come in after the danger has passed. Brain damage can never be undone.

Source: The World Health Organization

This video educates parents about newborn jaundice and the importance of supplementing.

brain-threatening Jaundice is preventable

Jaundice high enough to require phototherapy happens to about 15% of newborns (according to a large 2018 study). Prevention of phototherapy from insufficient breastfeeding can be prevented with temporary supplementation. 

Ella (now two years old) was one of these newborns. (Her mother, Becca shared her story with us in 2019, after her baby experienced multiple complications of insufficient milk, while she received loads of professional advice not to supplement.) Ella wouldn’t have been supplemented with formula under these guidelines because her jaundice wouldn’t have been considered severe enough. Her pediatrician would probably disagree, given that he’s watching her closely for suspected developmental delay—a known complication of severe jaundice:

Ella, under phototherapy lights

Becca (Ella’s mother) and other parents of babies who experienced high bilirubin levels have to live with the knowledge that their babies didn’t get enough to eat and that it may have affected their brains. The psychological trauma of this cannot be overstated.

Medical Ethics: “do no harm” and informed consent

Rarely are parents told that increased feeding from supplementation with formula (or banked donor human milk if available) can prevent as well as reduce high bilirubin levelsshorten the need for costly and emotionally grueling hospitalizations, and most importantly, reduce their baby’s exposure to a substance that damage brain cells.

Instead of emphasizing the dangers of excessive jaundice, the guidelines claim that the higher bilirubin levels commonly found in exclusively breastfed newborns may be beneficial because bilirubin is an “antioxidant.” Studies on excessive jaundice are very clear—high bilirubin levels can result in developmental delay, cognitive impairment, and behavioral and psychiatric disorders. There are simply no facts—none—to support their idea that there are benefits.

In every other area of medicine, patients (and parents of patients) receive informed consent and counseling about their options, especially when a serious complication like excessive jaundice can occur. However, providing this information is not currently standard practice. In reality, the failure to fully inform parents of the causes (e.g., insufficient milk intake) and risks of newborn jaundice commonly result in parents going home believing they are doing what is best for their infants by avoiding formula supplementation. If their infant does not receive enough milk because the milk comes in late or it is not enough, then they may find a distressed or lethargic jaundiced, and dehydrated baby that now requires hospital admission for conditions that can cause permanent disability. It is unbelievable—yet true—that parents aren’t being informed that insufficient feeding problems and jaundice are currently the leading causes of newborn rehospitalization.

This lying by omission is an outrageous violation of patient rights.

Parents should be told that temporary supplementation in response to signs of infant hunger and jaundice can prevent and treat these complications. Supplemental milk, whether it be formula or banked donor milk, can reduce bilirubin levels in both insufficiently fed babies and babies who have excessive bilirubin due to other medical conditions (like blood type incompatibility) because elimination through digestion is the way babies remove bilirubin.

While exclusive breastfeeding can be resumed when the full milk supply has come in, and the danger has passed, brain damage can never be undone.

 

Sydney F.’s baby was supplemented for five days using our feeding plan, then exclusively breastfed. She is still breastfeeding at 11 months.

 

The authors’ concern seems to be that if parents are made aware that breastfeeding isn’t perfect, they might entirely stop. Or worse, parents may come to believe that there can be benefits to supplementing some breastfed babies with formula (especially jaundiced newborns) and that the narrative that exclusive breastfeeding is best for all babies (with rare exceptions) is false.

Parents can understand the concept of a temporary nutritional intervention to bridge the gap until their supply increases and how this can protect their baby and support continued breastfeeding. In other words, you don’t have to choose between breastfeeding and reducing your baby’s risk of excessive jaundice—you can do both! 

Five well-designed studies  suggest that they do understand this and that breastfeeding isn’t destroyed with temporary small supplements. How many clinical trials have shown that judicious supplementation impairs sustained breastfeeding? None. Regardless—and this is important—what gives anyone the right to withhold information because it might change how a parent chooses to feed their child?

WHEN PHOTOTHERAPY ISN’T ENOUGH: EXCHANGE TRANSFUSIONS

The American Academy of Pediatrics—the authority that advises all pediatricians—now recommends that pediatricians should not offer formula supplementation for jaundiced babies receiving phototherapy without signs of “dehydration and/or insufficient intake,” which they do not define until they are “approaching exchange transfusion levels.” An exchange transfusion is essentially a blood transfusion done when a jaundiced baby’s blood has become so toxic from high bilirubin levels that they risk severe brain damage, a condition called kernicterus.

Baby Finn was set up for a blood transfusion for jaundice. Photo by Jim Campion (his father) via Flickr

 

“Signs of dehydration” range from a slightly dry mouth to total lack of urination and a sunken fontanel (soft spot on babies’ heads). “Insufficient intake” can mean anything from insufficient to make the baby full and comfortable to only enough milk to keep the baby out of danger. We assume they mean the latter, as the Academy of Breastfeeding Medicine, which sets the standards for newborn exclusive breastfeeding management under the Baby Friendly Hospital Initiative endorsed by the AAP guideline, says that if supplementation is necessary, only 1–3 teaspoons (5–15 ml) on days 1 and 2 should be given, respectively. This is despite evidence that the newborn stomach is 20 mL at birth and that much higher volumes of supplemental feedings than they recommend actually reduces rates of jaundice readmission

How much milk a baby needs: Milk Calculator

How can the AAP discourage pediatricians from offering parents the choice to reduce their child’s bilirubin levels with formula when supplementing can rapidly reduce bilirubin levels, shorten the need for phototherapy, and prevent levels that can require a blood transfusion for any baby with high bilirubin levels?

Studies have shown elevated markers of brain injury in the blood occur by bilirubin levels of 19 and 20 mg/dL. Large studies have shown increased risk of developmental problems, cognitive impairment, speech/language impairment and behavioral problems in newborns who develop high bilirubin levels, even in the moderate range of 13.5–19 mg/dL, well below the threshold for exchange transfusion. These impairments are from BIND—bilirubin induced neurological dysfunction—which is less severe than kernicterus, but still seriously disabling.  

Have they ever met a parent whose child has to live with the lifelong disabilities caused by kernicterus, as shown in this video? 

Anyone familiar with the devastating impact of kernicterus would not be so casual about jaundice; in fact, they would be outraged at the suggestion in this report.

How can the AAP be trusted with making recommendations on infant feeding when they appear to have lost perspective on what constitutes safe versus unsafe conditions for infants?

Chloe’s baby Lucas

Can we all agree that infant formula is far better than the risk of brain damage? Can we at least let parents know these facts and put the decision in their hands? Can we please prioritize protecting babies’ brains over avoiding formula?

 

Written by Lynnette Hafken, MA, IBCLC, with Christie del Castillo-Hegyi, MD, and Jody Segrave-Daly, RN, IBCLC (Retired)

Resources

 

 

 

Neonatal Nurse Practitioner Speaks Out About The Dangerous And Deadly Practices Of The BFHI

by Christine K.

When the Fed Is Best Foundation launched two years ago, a few nurses sent us messages about their experiences working in a Baby-Friendly Hospital Initiative (BFHI) hospital. They shared common concerns about watching exclusively breastfed babies crying out in hunger from not enough colostrum while being refused supplementation just so that high exclusive breastfeeding rates were met. Two years later, we now receive messages from nurses, physicians, lactation consultants, and other health professionals, regularly. They express their concerns while asking for patient educational resources. They tell us their stories and they need support and direction on what to do about unethical and dangerous practices they are forced to take part in. We collected their stories and are beginning a blog series on health professionals who are now speaking out about the Baby-Friendly Health Initiative (BFHI) and the WHO Ten Steps of Breastfeeding.

Christine K. is a Neonatal Nurse Practitioner currently working in a BFHI Hospital with 25 years of experience. She has worked in both BFHI and non-BFHI hospitals and talks about her concerns about taking care of newborns in the Baby-Friendly setting.

Regarding Unsafe Skin-To-Skin Practices

In BFHI facilities, skin-to-skin is mandated. The protocol calls for skin-to-skin at birth, for the first hour, then ongoing until discharge. New mothers are constantly told that it is important for bonding, for breastfeeding, for milk production and for temperature regulation of the newborn. Baby baths are delayed for skin-to-skin time and nurses are required to document in detail the skin-to-skin start and end times. There is no education on safety regarding skin-to-skin time, only that it is to be done. I have been responsible for the resuscitation of babies who coded while doing skin-to-skin. One died, and the other baby is severely disabled. Mothers are not informed of the risks of constant and unsupervised skin-to-skin time. Mothers have complained to me that they felt forced to do skin-to-skin to warm up their cold or hypoglycemic infant because they are told skin-to-skin time will help their infant resolve these issues when in fact it doesn’t. There is also no assessment of the mother’s comfort level with constant skin-to-skin. It’s very discouraging to hear staff say things like, “That mother refused to do skin-to-skin,” like it was a crime or an act of child abuse. The judgment is harsh on mothers who fail to follow the protocol. I have noticed that partners are pushed to the side, especially in the first hour of life, not being able to hold their newborn, due to this strict policy. Their involvement has been discounted in the name of the exclusive breastfeeding protocol. Continue reading

Nurses Are Speaking Out About The Dangers Of The Baby-Friendly Health Initiative

When the Fed Is Best Foundation launched two years ago, a few nurses sent us messages about their experiences working in a BFHI hospital. Some of the nurses felt comfortable speaking out because they left their jobs or retired early, as they did not want to be part of the restrictive breastfeeding policies that were implemented. They shared common concerns of watching exclusively breastfed babies being refused supplementation, while babies were crying out in hunger from not enough colostrum which resulted in NICU admissions.

Two years later, we now receive messages from nurses, physicians, LC’s and other health professionals, regularly.  They express their concerns while asking for help and for patient resources. They tell us their stories and they need support and direction of what to do about unethical and dangerous practices they are forced to practice. We collected their stories and are beginning a blog series of health professionals who are now speaking out about the Baby-Friendly Health Initiative and the WHO Ten Steps of Breastfeeding. Continue reading

The Fed is Best Foundation’s Top Priority is Saving Babies’ Lives

Christie del Castillo-Hegyi, M.D., Co-Founder of the Fed is Best Foundation

In response to a letter written by 1000 Days director, Lucy Martinez-Sullivan and follow-up editorial from Kimberly Seals Allers, we wanted to take an opportunity to set the record straight.The mission of the Fed is Best Foundation is to protect infants from complications and injuries resulting from accidental starvation under currently promoted breastfeeding policies. In order to protect infant safety and ensure the patient and human rights of mothers and babies, we have built a non-profit organization committed to: (1) the study of exclusive breastfeeding complications that can result in brain injury and, in the most severe instances, death; and (2) raising public awareness to signs of infant hunger and the consequences that can result based on peer-reviewed research.

As part of our public health awareness commitment, the Fed is Best Foundation has developed and compiled extensive resources for parents and health professionals to promote safe breastfeeding and safe infant feeding policies based on evidence, including, the science of infant feeding, the caloric and fluid requirements of newborns and the caloric yield of exclusive breastfeeding. These core matters of infant feeding are shockingly absent from current breastfeeding curricula and protocols. Our Foundation is not against breastfeeding; it is for safe breastfeeding and close monitoring to prevent complications and injuries to infants reported in the medical literature, the media and by the thousands of mothers who have sent us their stories, which we receive each and every day. Continue reading

World Health Organization Revised Breastfeeding Guidelines Put Babies at Risk Despite Pleas from Experts—Informing the Public “Not a Top Priority”

By the Senior Advisory Board of the Fed is Best Foundation

A key recommendation of the 1989 World Health Organization Ten Steps to Successful Breastfeeding which guides the Baby-Friendly Hospital Initiative (BFHI) is: “give infants no food or drink other than breast-milk, unless medically indicated.” This has led to serious complications from accidental starvation of babies, including dehydration, hyperbilirubinemia (jaundice) and hypoglycemia (low blood sugar) — known causes of infant brain injury and permanent disability. Last week, the WHO issued draft revised breastfeeding guidelines, failing to revise this recommendation. These guidelines define the standard of care for breastfeeding management in all healthcare facilities worldwide. Nearly 500 U.S. hospitals and birthing centers and thousands more worldwide that meet the criteria of the BFHI are certified as Baby-Friendly, adhering to the application of the WHO’s Ten Steps.

On Sept. 22, 2017, senior members of the Fed is Best Foundation, and guests including a neonatologist from a leading U.S. tertiary care hospital and a pediatric endocrinologist, Dr. Paul Thornton, M.D, from Cook Children’s Hospital Fort Worth, lead author of the Pediatric Endocrine Society’s newborn hypoglycemia guidelines, met via teleconference with top officials of the WHO Breastfeeding Program: Dr. Laurence Grummer-Strawn, Ph.D., Dr. Nigel Rollins, M.D. and Dr. Wilson Were, M.D. to express their concerns about the complications arising from the BFHI Ten Steps and to ask what, if any, monitoring, research, or public outreach the WHO has planned regarding the risks of accidental starvation of exclusively breastfed newborns. The Foundation members who attended were 1) Christie del Castillo-Hegyi, MD, Co-Founder, 2) Jody Segrave-Daly, RN, IBCLC, Co-Founder, 3) Julie Tibbets, JD, Partner at Alston & Bird, LLP, Pro-Bono Attorney for the Foundation, 4) Brian Symon, MD, Senior Advisor, and 5) Hillary Kuzdeba, MPH, former quality improvement program coordinator at a children’s hospital, managing infant feeding projects and Senior Advisor.

Emails confirming meeting between the WHO and the Fed is Best Foundation available here.

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Fear NOT Facts Contained in Baby-Friendly Formula Feeding Waiver Forms

By Christie del Castillo-Hegyi, M.D., Co-Founder of the Fed is Best Foundation

The primary reason why newborns experience starvation-related complications every single day as a result of the Baby-Friendly protocol is because the complications associated with the protocol are hidden from mothers who seek to breastfeed.  The primary objective of the Baby-Friendly Hospital Initiative is high exclusive breastfeeding at discharge.  Unfortunately, because the rates of insufficient breast milk and delayed lactogenesis II are high among mothers, the necessary consequences of hospital policies that seek high EBF at discharge rates are higher starvation-related complications like hyperbilirubinemia, hypernatremia, dehydration and hypoglycemia, all of which can cause newborn brain injury and permanent disability.  Below is an example of the way mothers are made to fear formula supplementation while the risks of NOT supplementing are hidden.  This is a waiver form published on the California Department of Public Health Website to provide an example of a model formula waiver form for hospitals.

Here are examples of FEAR not FACTS contained in formula feeding waiver forms that Baby-Friendly hospitals require moms to sign before they allow a newborn to be formula-fed.

1. FEAR: Supplementation CAUSES delayed milk production.

FACT: The known risk factors for delayed milk production include being a first-time mom, cesarean delivery, flat or inverted nipples, higher BMI > 27, prolonged stage II of delivery (when a mom pushes to deliver), having a large baby, excessive blood loss, being an older mom > 30, PCOS, diabetes, hypothyroidism, insufficient glandular tissue, retained placenta to name a few. While supplementation may be ASSOCIATED with delayed milk production, supplementation is in fact a REFLECTION of the need to supplement a baby who is being underfed due to delayed copious milk production.  (Pediatrics 2003, 112 (3 Pt 1): 607-19)

2. FEAR: Not exclusively breastfeeding puts my child at risk of jaundice.

FACT: Exclusive breastfeeding is among the highest risk factors for excessive jaundice requiring phototherapy admissions according to the American Academy of Pediatrics and 10-18% of exclusively breastfed newborns experience starvation jaundice from insufficient milk intake according to the Academy of Breastfeeding Medicine. Exclusively breastfed newborns are at higher risk of jaundice than supplemented and formula-fed newborns due to the smaller volumes of milk they receive as milk helps the baby pass bilirubin into the stool. In fact one of the ways jaundice is treated and prevented is through supplemental milk feeding.
Pediatrics, July 2004, VOLUME 114 / ISSUE 1, BREASTFEEDING MEDICINE, Volume 5, Number 2, 2010

 

3. FEAR: Not exclusively breastfeeding will cause my baby to be underfed

FACTS: In the largest studies of supplemented/formula-fed vs. exclusively breastfed healthy, term newborns from a large Baby-Friendly Hospital system, the exclusively breastfed babies lost almost twice as much as the supplemented/formula-fed babies. 10% of vaginally-delivered and 25% of cesarean-delivered EBF newborns lost excessive weight of >10% while NONE of the formula-fed newborns experienced this complication. In fact, exclusive breastfeeding at discharge is associated with an 11-fold higher risk of rehospitalization for dehydration and underfeeding.

Early Weight Loss Nomogram of Formula-Fed Newborns. Hospital Pediatrics May 2015, VOLUME 5 / ISSUE 5

Early Weight Loss Nomogram of Exclusively Breastfed Newborns.  Pediatrics January 2015, VOLUME 135 / ISSUE 1

Rehospitalization for Newborn Dehydration. Arch Pediatr Adolesc Med. 2002;156:155-161

4: FEAR: Supplementing will CAUSE low blood sugar and colostrum protects my baby from it.

FACT: In a study of newborns fed antenatally expressed colostrum along with direct latch feeding of colostrum when compared to those who did not receive expressed colostrum, the babies fed expressed colostrum in fact had higher rates of hypoglycemia requiring admission.  Lancet 2017, 389: 2204-2213

So NO, colostrum does not protect against hypoglycemia. In fact in the most recent study of EBF newborns, 10% had blood glucose levels low enough to increase risk of lower long-term academic achievement. An even older study on low blood sugar in EBF newborns, 53 out of 200 or 26.5% developed low blood sugar within the first 6 hours of life. What protects against hypoglycemia is providing a child their full caloric requirement, which is 100-120 Cal/kg/day to prevent them from running out of caloric reserve.

Study of Asymptomatic Hypoglycemia in Full Term Exclusively Breastfed Neonates in First 48 Hours of Life Journal of Clinical and Diagnostic Research. 2015 Sep, Vol-9(9): SC07-SC10
Association Between Transient Newborn Hypoglycemia and Fourth-Grade Achievement Test Proficiency: A Population-Based Study JAMA Pediatr. 2015;169(10):913-921.
Nutritional management of newborn infants: Practical Guidelines. World J Gastroenterol 2008 October 28; 14(40): 6133-6139      

5. FEAR: Introduction of cow’s milk will lead to cow milk protein allergy.

FACT: In a study of over 13,000 children, earlier introduction within the first 2 weeks of life of cow’s milk REDUCED their risk of cow milk protein allergy by 19-fold.

Early exposure to cow’s milk protein is protective against IgE-mediated cow’s milk protein allergy.  J Allergy Clin Immunol. 2010 Jul;126(1):77-82.e1.

6. FEAR: Exclusive breastfeeding is the ideal way of feeding every baby and there are no risks associated it, only risks of NOT doing it.

FACT: The most significant risks to a newborn’s life and brain come from the fasting conditions imposed by exclusive breastfeeding before full milk production and these risks are hidden from mothers to gain compliance with exclusive breastfeeding.

A review of 116 cases of breastfeeding-associated hypernatremia in rural area of central Turkey. J Trop Pediatr. 2007 Oct;53(5):347-50. Epub 2007 May 12.

Hypernatremic Dehydration in Breastfed Term Infants: Retrospective Evaluation of 159 Cases. Breastfeed Med. 2017 Jan/Feb;12:5-11.

Long-Term Neurodevelopmental Outcome of Neonates with Hypernatremic Dehydration. Breastfeed Med. 2017 Apr;12:163-168

Of Goldilocks and Neonatal Hypernatremia. Academy of Breastfeeding Medicine Blog.

7. FEAR: Just one bottle will ruin my child’s future health.

FACT: Just one bottle can save a child’s life and save them from a lifetime of disability.

If I Had Given Him Just One Bottle, He Would Still Be Alive.

Letter to doctors and parents about the dangers of insufficient exclusive breastfeeding

#FactsnotFear #FedisBest #BFHIShowMeYourFacts


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Markers of Brain Injury is Present in the Blood of Newborns Requiring Phototherapy for Jaundice

by Dr. Christie del Castillo-Hegyi, M.D. 

A study published in the journal Pediatrics and Neonatology in September, 2014 showed that newborns diagnosed with hyperbilirubinemia, or abnormal jaundice, high enough to require phototherapy had significantly higher blood levels of S100b, a protein known to be released by damaged brain cells when significant brain injury occurs.  They studied 62 jaundiced newborns who required phototherapy and compared them to 30 healthy non-jaundiced newborns and compared the relative levels of S100b in the blood, as well as other molecules that are associated with oxidative stress, a phenomenon that occurs when living cells die.  All except 2 babies in each group were breastfed and none had G6PD, a condition that causes abnormally high bilirubin unrelated to breastfeeding-related dehydration.

They found that the babies who had hyperbilirubinemia high enough to require phototherapy (bilirubin levels of 20.58±2.96 mg/dL) had significantly higher levels of S100b than the healthy babies, (S100B levels 87.3± 2.63 pg/mL in healthy babies vs. 124.97 ± 123.05 pg/mL in phototherapy babies; p = 0.032).  They also found higher levels of MDA, a marker of oxidative stress from cell death, in the babies requiring phototherapy as well (5.55±0.6 nmol/mL vs. 7.72±0.75 nmol/mL; p<0.001).  The levels of S100b was NOT reversed by phototherapy, suggesting that phototherapy neither increased brain cell death nor reversed it.  The purpose of phototherapy is to prevent further brain injury caused by hyperbilirubinemia but it does not reverse brain injury.

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High Rates of Newborn Hospitalizations for Jaundice Requiring Phototherapy in a Baby-Friendly-Compliant Hospital System

By Christie del Castillo-Hegyi, M.D.

The true rates of excessive jaundice and hospitalizations of newborns for phototherapy due to jaundice has been recently published in JAMA Pediatrics published online April 11, 2016. In a study of 104,460 babies born between January 2010 and December 2013 in the Kaiser Permanente Northern California (KPNC) Healthcare System reported than an astonishing 12.4% of babies developed pathological hyperbilirubinemia of greater than 15 mg/dL in the study period, which has been shown in the scientific literature to increase risk of developmental disabilities. This translates to 12,953 babies or almost 12 babies a day.  In addition, 5.7% of babies required phototherapy admission, translating to 5954 newborns or 5 babies a day.

California has a state mandate to require Baby-Friendly certification in all its hospitals by 2020, which requires that >80% of eligible newborns be exclusively breastfed at discharge, the primary quality metric of the BFHI. Many California hospitals are working towards that designation and their exclusive breastfeeding rates at discharge are tracked by the California Department of Public Health. Estimates of excessive jaundice in the KPNC hospital system, which has among the highest exclusively breastfeeding rates at discharge, all except 2 reaching the >80% requirement, was described by this study. Seventy-one percent of these hospitalizations were extensions of the original birth admission, which means pathological jaundice was detected before discharge and the newborn’s hospital stay was extended to reduce the pathological effects of bilirubin, namely brain injury.

Severe newborn jaundice and phototherapy increase the risk of developmental disability

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