Early Postpartum Formula Supplementation and Breastfeeding Rates at 6-12 months
by Anne Eglash MD, IBCLC, FABM
Breastfeeding newborns sometimes need supplementation in the first few days postpartum for medical indications such as a delay in lactation, low milk supply, excessive weight loss, poor feeding at the breast or late-preterm status.
But what happens if all newborns are supplemented based solely on the degree of weight loss, before it becomes medically indicated? Does that impact breastfeeding success? One theory has been that if excessive weight loss can be prevented by small amounts of formula supplementation early, then larger volumes of formula supplementation can be avoided.
The article for this week’s CQW is a randomized control trial that enrolled 164 breastfeeding dyads who were 24-72 hours old with newborn weight loss at or above the 75th percentile based on the Newborn Weight Loss Tool (NEWT). What does 75th % mean? An example would be an 8 lb infant born vaginally, who is down 8.3% from birth weight, to 7 lb 6 oz at 48 hours. Not a typical candidate for a newborn who is otherwise nursing well.
Half of the newborns were supplemented with 10 ml of hydrolyzed formula using a syringe after each nursing. The mothers were instructed to stop the supplementation once she felt copious milk production. The other half, the controls, were given the same level of breastfeeding support as the intervention group.
Breastfeeding rates were reported for 1 week, 6 months and 12 months postpartum.
- Infants who received early routine formula supplementation were less likely to be exclusively breastfeeding 1 week, vs infants who did not receive early formula supplementation.
- The 6 month exclusive and any-breastfeeding rates were lower for the formula supplementation group vs the no-supplementation group.
- The 12 month breastfeeding rates were similar between the formula supplementation group vs the no-supplementation group.
- Receiving formula at 1 week postpartum was very strongly associated with low breastfeeding rates at 6 and 12 months.
See the Answer
Abstract
Importance
Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants.
Objective
To determine whether structured, short-term formula supplementation for at-risk neonates affects the proportion still breastfeeding at 6 and 12 months.
Design, Setting, and Participants
This randomized clinical trial conducted at 2 US academic medical centers enrolled 164 exclusively breastfeeding mother-infant dyads of mothers who were not yet producing copious milk and infants who were 24 to 72 hours old with newborn weight loss at or above the 75th percentile for age. Participants were enrolled from January 2015 through September 2016.
Interventions
Early Limited Formula (ELF), a structured formula supplementation protocol (10 mL formula fed after each breastfeeding until mothers produced copious milk), compared with control dyads, who continued exclusive breastfeeding and received a safety teaching intervention.
Main Outcomes and Measures
The study’s primary outcome was any breastfeeding at 6 months. Secondary outcomes included age at breastfeeding cessation and any breastfeeding at 12 months. All outcomes were assessed by maternal phone survey.
Results
Eighty-two newborns were randomized to ELF and 82 to the control group. Mean (SD) maternal age was 31.4 (5.9) years, and 114 (69.5%) self-identified as non-Hispanic white; 20 (12.2%), Hispanic; 17 (10.4%), Asian; 5 (3.0%), non-Hispanic black; and 7 (4.3%), other. Compared with controls, mothers randomized to ELF were less likely to be married (n = 53 [64.6%] vs n = 66 [80.5%]; P = .03) and had shorter mean (SD) intended duration of breastfeeding (8.6 [3.4] vs 9.9 [4.4] months; P = .049). Median (interquartile range) duration of breastfeeding in the cohort was 9 (6-12) months. At 6 months, 47 (65%) infants randomized to ELF were breastfeeding, compared with 60 (77%) of the control infants (absolute difference, –12%; 95% CI, –26% to 3%; P = .12). At 12 months, 21 of the 71 ELF infants available for analysis (29.6%) were breastfeeding, compared with 37 of the available 77 (48.1%) control infants (risk difference, –18%; 95% CI, –34% to –3%). Marital status and intended breastfeeding duration were both associated with breastfeeding duration; models adjusting for these found a hazard ratio for time-to-event of breastfeeding cessation through 12 months of 0.74 (95% CI, 0.48-1.14) for ELF infants compared with infants in the control group.
Conclusions and Relevance
In this cohort with high breastfeeding prevalence, ELF was not associated with any improvement in breastfeeding duration. Future research should examine the effect of ELF in populations at higher risk of early cessation.
The 12 month breastfeeding rates were higher among the no-supplementation group.
Some of you may remember the splash these authors made in 2013 when they published a small randomized trial involving 40 infants at 5% weight loss, where 20 were supplemented with 10ml of formula after each feeding, vs no supplementation. In that study, they surprised the world by reporting that the supplementation group used less formula at 1 week postpartum and had markedly higher exclusive breastfeeding rates at 3 months. Many surmised that giving very small amounts of formula early postpartum prevented excessive weight loss necessitating larger volumes of formula supplementation. One outcome of that study was Similac’s new ‘supplementation’ formula.
Thankfully, this new, more robust study, refutes what they found in 2013, and supports the evidence demonstrating that exclusive breastfeeding postpartum is associated with improved long term breastfeeding success.
In this day and age, why did the research group not use pasteurized donor human milk, the use of which is increasingly common in term and late-preterm hospitalized newborns? I don’t know, but should mention that 2 of the authors disclosed that they are paid consultants for formula manufacturers.
Janet Oakeson
Thank you this was very interesting. I am glad it showed it is best not to supplement with formula and to totally breastfeed. I agree, if supplementation is needed use donor breast milk or ask the mom to do hand expression and feed the baby her own mother’s milk.
Amy Clark
This doctor is in my community
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3666109/
Fritzi Drosten
Thank you for your comments. I had not seen this article, and I am not surprised at the results. I surmise that robust infants who loose a lot of weight and are not getting sufficient colostrum could indeed use donor milk, but could an alternative could be some hydration with some water? I see thirsty babies. Having worked in hospitals and homes with newborns for many years, I started out with the glucose water supplements being required, then moving to nothing unless it’s formula. I see mothers not wanting to use formula, but nurses and LC’s have been using the oral sucrose drops for assisting the latch or placing it on pacifiers indiscriminately, in those institutions that have not locked them up…i think it sometimes helps them lubricate the nipple/wets their throat, but can also inhibit feeding behavior(thinking they have fed, baby goes to sleep), but could be providing some hydration?. Anyway we’re still trying to solve feeding issues early on…donor milk probably closest to what really happened in early, early days, which is another mother fed baby a little, then gave baby back to its mother…
Anne Eglash
Plain water or sugar water should never be given to infants who are have excessive weight loss due to insufficient milk intake. They need both calories and fluid from breastmilk, and if that is not available, they need formula. Plain water or sugar water instead of milk is dangerous, as it can cause hyponatremia, hypoproteinemia, hypoglycemia, seizures, etc.
Lynnette Hafken
Thank you for this analysis! Since it was a small study and there are many factors that can influence outcome at 12 months, I think it is important to interpret this cautiously. Also, although more in the EBF group were breastfeeding at 6 months, it was not statistically significant, so that needs to be looked at further. We also need to keep in mind the disruption of breastfeeding that can occur with a rehospitalization or a NICU admission of a baby; reducing those also helps maintain breastfeeding.
While we absolutely need to be cautious about introducing formula so early, we need to also be cautious not to let emotions blind us to evidence. Preventing excessive weight loss and avoiding readmissions using two teaspoons of formula (or even better donor milk) for babies above the 75th percentile for weight loss could prevent those babies from having very large formula supplements later after weight loss becomes truly excessive.
Since this was a RCT, they needed to keep it simple, but if policy were being made, I would want to consider other clinical signs besides weight loss, including the mother’s assessment of how well her baby is breastfeeding. I just don’t think we should have a knee jerk reaction to dismiss this research because it suggests routine supplementation for a subgroup of babies. We already routinely supplement for other subgroups (e.g. low glucose), and this study is just looking at the best weight loss threshold.
Anne Eglash
Yes, I agree that there are more questions than answers. Yes, I agree that readmission for weight loss, jaundice, and other negative outcomes related to insufficient infant feeding are highly undesirable, and should be prevented by all means. However, I don’t think that applying this protocol in real life would be medically appropriate, or even benign as a means of preventing these negative outcomes. It is frankly unfair to subject all infants at 5% weight loss to formula supplementation, because this is not a risk free intervention. It would be more appropriate to maximize the mother’s milk supply by hand expression/pumping after nursing and supplementing the expressed milk/colostrum. This is based on the most basic of lactation physiology principles. If still insufficient volumes, then donor human milk is more physiologically appropriate than formula. IF donor milk is not available, then formula does need to be used.
R. Konoff
I did not have access to the full text, but the abstract doesn’t mention EXCLUSIVE breastfeeding outcomes at all. “At 6 months, 47 (65%) infants randomized to ELF were breastfeeding…” – it doesn’t say exclusive. In fact, it clearly states that “The study’s primary outcome was any breastfeeding at 6 months.” So answer “B” above may be true, but it’s not reflected in the abstract.
And as Lynette points out, the “any breastfeeding at 6 months” result was clearly not significant (P = .12). So in this small sample, with several statistically different parameters between the participants in the intervention group and the control group, results should be taken cautiously, and as evidence of the need for further study.
I do agree that donor milk should always be the supplement of choice when needed, in the absence of availability of mother’s own milk.
Anne Eglash
The abstract does not disclose the Odds Ratios (OR) for any breastfeeding at 6 mo, and for exclusive breastfeeding at 6 mo, both of which were measured in the study. The OR of any breastfeeding at 6 months was 0.60, and 0.69 for exclusive breastfeeding. The closer the OR is to 1, the greater likelihood that supplementation has no effect. If the OR is over one, then supplementation is associated with a greater likelihood of breastfeeding at 6 mo. The lower it is from 1, the more likely it is that supplementation is NOT associated with the outcome, ie, any or exclusive breastfeeding at 6 mo.
The odds ratio of breastfeeding at 12 months was 0.70.
The abstract does not mention that the supplemented group was less likely to have been exclusively nursing at 1 week of age (63.3%) as compared to the unsupplemented group (78%).
Muriel Boette
Excellent comments about this “study”. In our private ped practice we aimed for prevention of newborn wt. lost. One consideration was the amount of IV fluids the undelivered mom received that appears as wt. for the baby. We had the privilege of assisting with the first feeding to establish appropriate milk transfer in L&D or post op recovery. If more assistance was needed, the mom was visited in the Mother/Baby unit. Baby’s and mom’s daily assessments were also key. Then follow up with the mom on day 2 after discharge. Expressed milk via cup feeding was used as needed.
This may seen over kill but the health benefits and less expense paid off handsomely.
Sarah Stevens
One of the authors of the 2013 study was a paid consultant to Abbott Nutrition, Mead-Johnson, Nestle and Pfizer. The same author is listed on this 2019 study. This makes me suspicious that the outcome measures were very carefully selected to obscure the risk formula supplementation poses to breastfeeding outcomes and to play up the breastfeeding behaviors in mixed feeding outcomes.
Lynnette Hafken
The lead author, Valerie Flaherman, is a co-author of the ABM protocol on hyperbilirubinemia. Her credentials as a breastfeeding researcher are impeccable. While I’m disappointed that a co-author saw fit to associate with Mead-Johnson, it’s not like the study was funded by them; NIH did.
I don’t like having to supplement either, but when you weigh the risks of a small and limited amount of formula with the risks of not supplementing a baby who is on a trajectory towards excessive weight loss (with all the risks that go along with that), I think the latter is riskier, both to the baby and to breastfeeding.
Anne Eglash
These are the 2 issues that I believe contribute to unethical care of these subjects, and that violate principles of appropriate breastfeeding management:
1. The decision to supplement was based on 1 criteria- being in the 75% for weight loss according to the NEWT scale. The principles of appropriate breastfeeding management embrace the need to evaluate the dyad, not just the infant. For example, an infant who is on a downward trend weight-wise may be a sleepy nurser, and just needs to be supplemented with mothers’ own expressed colostrum, not artificial feedings. In addition, in this study, there was no mention of supporting lactation for the mother while supplementing these infants. I am certainly all for supplementation when needed, to prevent any complication. But every dyad deserves individualized evaluation and decision making on care, which includes using mother’s own milk whenever possible, and informed decision making.
2. If I had been on the IRB committee, I would NOT have approved this study There is very strong evidence that giving formula in the first 3 days of life for an infant who will be exclusively breastfed markedly increases that infant’s risk of cows milk allergy. Formula also increases the risk of a change in the infant’s microbiome. From my understanding, the goal of this study was to see if early limited supplementation would help support breastfeeding at 6 and 12 months. So why would they choose formula? Why not use donor milk, which is an increasingly common method of supplementation for well infants in the first few days pp?
Nancy Forrest
Interesting research, and great comments. The high motivation to exclusively breastfeed in both groups is evident as breastfeeding percentages at 6 and 12 months are higher than national averages in both groups, arent’s they? The differing results might not be statistically significant, But I am wondering about 2 issues that I constantly focus on in clinical practice: milk flow sensitivity of the infant – will the baby be easily sabotaged with a faster flow of milk during those first 3 days when colostrum appears to be ‘thicker and stickier’ than transitional and mature milk; and, – importance of stimulating breasts using hand expression and double pumping EVERY time infant ingests more milk volume than what transferred from the breast at that feeding. But I also realize that instructing the mom to pump EVERY time infant is supplemented can potentially physically and emotionally overwhelm the new mom. So I am reminded of “First Do No Harm”