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| Dr. Enrique Jacome |
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 are 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."
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| Dr. Enrique Jacome |
An ingredient that naturally occurs in breast milk might be used to prevent premature babies from developing a deadly intestinal condition that currently is largely incurable, according to researchers at the University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh of UPMC in this week's online early edition of theProceedings of the National Academy of Sciences.
The story begins with a baby who is born too early, meaning before 36 weeks gestation, said senior author David Hackam, M.D., Ph.D., Watson Family Professor of Surgery, Pitt School of Medicine, and co-director of the Fetal Diagnosis and Treatment Center at Children's Hospital. Once stable, typically the baby is fed with formula because often breast milk is not readily available to premature infants.
"Within about 10 days of birth, the baby starts to vomit and a few hours later, the belly becomes distended and discolored," Dr. Hackam said. "It becomes clear that the child has developed a major problem in his or her tummy, and an X-Ray will usually confirm the diagnosis of necrotizing enterocolitis, or NEC, in which the intestinal tissue is dying. We have no choice but to remove the dead parts of the intestine, but despite surgery, half of these preemie babies still die from the condition."
Dr. Hackam and his team noted NEC occurs when the intestines start getting colonized with bacteria, a process that occurs normally after birth. They focused on toll-like receptor 4 (TLR4), an immune protein that is involved in recognizing microbes and which they recently discovered plays a role in gut development. In the current work, Hackam and colleagues found that TLR4 is present in higher amounts in the blood vessel lining in preemies than in full-term babies.
The study shows that unlike normal mice, those bred to lack TLR4 in their blood vessels did not develop NEC in a model designed to induce the condition. The findings indicate that bacteria in the blood activate TLR4 leading to a reduction in nitric oxide, which in turn narrows blood vessels and decreases blood flow, Dr. Hackam said.
"This pathway can be dangerous when the preemie's immature gut becomes inflamed from exposure to the bacteria normally present in the intestine," he said. "Abundant TLR4 triggers a shutdown of the blood supply to the intestine, leading to tissue death or necrosis."
Premature babies who are nursed rather than formula-fed are more likely to survive NEC, so co-author and nitric oxide expert Mark Gladwin, M.D., chief, Division of Pulmonary Allergy and Critical Care Medicine, Pitt School of Medicine, and director of Pitt's Vascular Medicine Institute, and the team took a closer look at the components of breast milk.
They found that breast milk contains high levels of sodium nitrate, which is converted to nitrite by gut bacteria. Nitrite can be directly converted to the vasodilator nitric oxide, which can both protect the intestinal lining and improve blood flow.
"The additional nitrite appears to overcome the effects of TLR4 activation and corrects the blood flow problem," Dr. Gladwin said. "When we gave formula supplemented with a sodium nitrate and nitrite analog to the premature mice, we saw improved blood flow in the intestine, and NEC did not develop."
Drs. Hackam and Gladwin are testing the compound, which is FDA approved for other uses, in other models of NEC with the hope that it could be routinely added to formula fed to premature infants to prevent NEC.
"This condition is frightening for parents and frustrating for doctors because currently there is little we can do to treat it," said Dr. Hackam, a pediatric surgeon. "I look forward to one day putting myself out of business and having a therapy that truly saves these children."
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| Dr. Enrique Jacome |
The emergency contraceptive "Plan B One-Step", also known as "the morning after pill", has just been approved by the FDA for use among women and girls at least 15 years old, without the need of a doctor's prescription.
Teva Women's Health, Inc. had previously made an application for Plan B One-Step to be available for sale over the counter, without the need of a prescription, to all women (of any age) last year, but the FDA did not approve it.
Plan B One-Step was approved by the FDA in 2009.
The company then decided to amend their application to make it available over the counter strictly for women 15 years of age and older. This new, amended application, did receive approval.
In order to ensure that the pills aren't sold to any girls younger than 15, the product will include the following labeling "not for sale to those under 15 years of age *proof of age required*, not for sale where age cannot be verified."
Cashiers, pharmacists and shop-assistants will be required to ask for the customer's age.
Plan B One-Step will be widely available as the company says it will distribute the pills to many retail outlets that have an onsite pharmacy, where they expect it to be sold in the family planning area. This way the contraceptive will be available during the retailer's operating hours regardless of whether or not the pharmacy is open.
Plan B One-Step is intended to be used as an emergency contraceptive, only in cases where the primary birth control (such as a condom) appeared not to have been effective. It will be available as a single 1.5 mg tablet to be taken within three days of having unprotected sex.
If a woman is already pregnant and takes Plan B One-Step it will not stop the pregnancy and there is no evidence of it harming a developing fetus.
The FDA Commissioner Margaret A. Hamburg, M.D., said:
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States.
The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."
The FDA approved Plan B One-Step without a prescription solely for women 15 years or older because of evidence suggesting that women of that age are likely to understand the product is not intended to be used on a routine basis and that it doesn't protect against sexually transmitted diseases.
It's especially important that women continually check for HIV or AIDS or other sexually-transmitted diseases and seek guidance for the best form of birth control.
The FDA stresses that emergency contraceptives such as Plan B One-Step aren't to be used on a routine basis.
To ensure that the age limitation is adhered to, Teva has said that it's willing to conduct an audit of age verification practices after the product has been approved.
A federal judge, in early April this year ordered the Agency to grant a 2001 citizen's petition that wanted OTC access to PLAN B legalized for women of all ages, and/or make Plan B One-Step available as an OTC medication with no restrictions on either age or point of sale. Teva's application to market PlanB One-Step for females aged 15+ years had been pending before the federal judge's ruling.
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