May 13, 2013 Recent public health efforts have focused extensively on reducing the amount of formula babies are given in the hospital after birth. But in the first randomized trial of its kind, researchers at UC San Francisco have found that giving small amounts of formula in the first few days of life to infants experiencing high levels of early weight loss actually can increase the length of time their mothers end up breastfeeding.
"Until now, we haven't explored if it is possible to identify babies who might benefit from early formula use. This study provides the first evidence that early limited formula (ELF) can provide important benefits to some newborns," said lead author Valerie Flaherman, MD, MPH, an assistant professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital. "Based on our findings, clinicians may wish to consider recommending the temporary use of small amounts of formula to new moms whose babies are experiencing significant early weight loss."
Study findings will be published online by the journal Pediatrics, and will appear in an upcoming print issue of the journal.
"Formula use has the potential to be a slippery slope to breastfeeding discontinuation, but ELF is a different way to envision using it," said Flaherman. "Rather than giving full bottles of formula that make it hard for the baby to return to the breast, ELF is a small amount of supplementation with a clear end point that alleviates some of the stress new mothers feel about producing enough milk."
Breastfeeding is known to offer wide-ranging preventive health benefits for babies, reducing their risk for infections and allergies, and providing the perfect balance of nutrients to help infants grow into strong and healthy toddlers. The American Academy of Pediatrics currently recommends that healthy mothers and infants should breastfeed exclusively for the first six months for maximum health benefits.
Women do not immediately produce high volumes of milk after childbirth. Instead, at first mothers secrete small amounts of colostrum, which contains high concentrations of nutrients and antibodies for the baby. During this period, babies often lose weight and new mothers may be concerned that their babies appear fussy or hungry. "Many mothers develop concerns about their milk supply, which is the most common reason they stop breastfeeding in the first three months," said Flaherman.
"But this study suggests that giving those babies a little early formula may ease those concerns and enable them to feel confident continuing to breastfeed," she said.
The study enrolled 40 full-term newborns between 24-48 hours old who had lost more than 5 percent of their birth weight. The babies were randomly assigned either to receive early limited formula (ELF), which consisted of one-third of an ounce of infant formula by syringe following each breastfeeding, or to continue with their intention to breastfeed exclusively. So as not to interfere with breastfeeding 8 to 12 times a day, the ELF babies were only given small amounts of formula. The syringe was used to avoid the babies developing nipple confusion -- when a baby develops a preference for a bottle nipple over the breast. The ELF babies stopped the formula when their mothers began producing mature milk, approximately two to five days after birth.
At the one week assessment, all the babies in both groups were still breastfeeding. However, only 10 percent of the ELF babies had received formula in the last 24 hours, compared with 47 percent of the control group.
After three months, 79 percent of the babies in the study who received early limited formula in the first days of life were still breastfeeding, compared with 42 percent of the babies who did not receive early limited formula. Additionally, 95 percent of the babies who received limited formula in the first few days were breastfeeding to some extent at three months, compared with 68 percent of the babies who did not receive early limited formula.
While impressed with the results of this small study, the authors urged caution in interpreting their results. "It will be important to see whether these results can be confirmed in future, larger studies and in other populations," said senior author Thomas Newman, MD, MPH, a professor of pediatrics and epidemiology and biostatistics at UCSF and a pediatrician at UCSF Benioff Children's Hospital.
The authors stress that the goal of this study is to help babies breastfeed for a longer duration, because breastfeeding is the best method for feeding infants. For some infants with high, early weight loss, this small study is the first to suggest that infant formula used at just the right time, in limited amounts, may help achieve the goal of long-term breastfeeding.
"The results of this study are provocative and challenge conventional wisdom," said James Taylor, MD, medical director for the University of Washington Medical Center's Newborn Nursery, who was unaffiliated with the study. "It is crucial that we have more randomized controlled trials on interventions to increase breastfeeding rather than relying on heavily confounded observational studies or biased expert opinion."
Co-authors include Janelle Aby, MD of the Department of Pediatrics at Stanford University; Anthony Burgos, MD, MPH, of the Department of Pediatrics, Kaiser Permanente Medical Center, Downey, CA; Kathryn Lee, RN, PhD of the Department of Family and Community Nursing at UCSF; and Michael Cabana, MD, MPH of the Department of Pediatrics at UCSF.
The research was supported by grants from the National Institute of Children Health and Human Development.
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- Valerie J. Flaherman, Janelle Aby, Anthony E. Burgos, Kathryn A. Lee, Michael D. Cabana, and Thomas B. Newman. Effect of Early Limited Formula on Duration and Exclusivity of Breastfeeding in At-Risk Infants: An RCT. Pediatrics, May 13, 2013 DOI: 10.1542/peds.2012-2809
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