The Milk, Growth and Microbiota Study
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/15/2018 |
| Start Date: | October 30, 2017 |
| End Date: | May 1, 2019 |
| Contact: | Valerie Flaherman, MD, MPH |
| Email: | Valerie.Flaherman@ucsf.edu |
| Phone: | 415-502-6166 |
Milk, Growth and Microbiota: A Randomized, Controlled Trial (RCT) of Donor Milk vs. Formula to Supplement Breastfeeding Late Preterm Newborns
Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty
feeding, establishing growth, and fighting off infection. Breastfeeding provides improved
nutrition to help fight infection, in part because breast milk encourages the growth of
healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth
preterm, their breasts are usually not quite ready to make milk; it can take several days to
have enough breast milk to match a baby's nutritional needs. If there is not yet enough
breast milk, formula is often used. However, formula can interfere with the growth of healthy
intestinal bacteria. An alternate nutritional option is donor milk from a certified milk
bank, which is available in all neonatal intensive care units (NICUs) in San Francisco.
However, no scientific studies have yet studied donor milk for late preterm infants, so
currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve
donor milk for infants born at <34 weeks. This study's investigators therefore propose the
"Milk, Growth and Microbiota (MGM) Study," a randomized controlled trial to compare banked
donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once
enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor
milk if they need additional nutrition until their mothers are making enough milk. After
enrolling the babies, investigators will weigh them daily to assess their growth. The
investigators will also collect infant bowel movements at baseline, 1 week and 1 month to
determine whether donor milk vs. formula impacts the type of bacteria in the baby's
intestine. If the study's results show that donor milk optimizes growth while helping
establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to
bolster neonatal nutrition for late preterm infants.
feeding, establishing growth, and fighting off infection. Breastfeeding provides improved
nutrition to help fight infection, in part because breast milk encourages the growth of
healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth
preterm, their breasts are usually not quite ready to make milk; it can take several days to
have enough breast milk to match a baby's nutritional needs. If there is not yet enough
breast milk, formula is often used. However, formula can interfere with the growth of healthy
intestinal bacteria. An alternate nutritional option is donor milk from a certified milk
bank, which is available in all neonatal intensive care units (NICUs) in San Francisco.
However, no scientific studies have yet studied donor milk for late preterm infants, so
currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve
donor milk for infants born at <34 weeks. This study's investigators therefore propose the
"Milk, Growth and Microbiota (MGM) Study," a randomized controlled trial to compare banked
donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once
enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor
milk if they need additional nutrition until their mothers are making enough milk. After
enrolling the babies, investigators will weigh them daily to assess their growth. The
investigators will also collect infant bowel movements at baseline, 1 week and 1 month to
determine whether donor milk vs. formula impacts the type of bacteria in the baby's
intestine. If the study's results show that donor milk optimizes growth while helping
establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to
bolster neonatal nutrition for late preterm infants.
In the U.S., 8% of all births occur between 34 0/7 and 36 6/7 weeks gestation and are
regarded as late preterm birth. Compared to term newborns, late preterm newborns have a much
higher risk of morbidity and mortality, in part because of difficulty establishing feeding
and growth. Breastfeeding optimizes the nutrition of these infants by supporting growth and
establishing a healthy intestinal microbiota. However, maternal breast milk production is
often delayed after preterm birth, which can hamper optimal growth. When this occurs,
clinicians may use formula to supplement breastfeeding. However, formula alters neonatal
intestinal microbiota and can impede some of the benefits of a human milk diet. Donor milk
from a certified milk bank could possibly be used instead of formula for supplementation
prior to the onset of copious maternal milk production. However, the use of banked donor milk
has never been studied in late preterm infants. The aim of this proposal is to report the
effects of banked donor milk vs. formula on growth and on intestinal microbiota among late
preterm, breastfeeding newborns who require additional nutrition before copious maternal milk
is available. This study's investigators therefore propose a randomized, controlled trial
enrolling late preterm newborns. Newborns will be randomly assigned either to breastfeed with
additional formula feedings, or to breastfeed with additional donor milk feedings. The
study's outcomes will be: (1) growth (rate of weight change), and (2) intestinal microbiota.
If the study finds that temporary use of donor milk supports growth and maintains healthy
intestinal microbiota until copious maternal milk becomes available, temporary use of donor
milk might be a postnatal strategy to bolster neonatal nutrition and optimize nutritional
support and growth for late preterm infants.
regarded as late preterm birth. Compared to term newborns, late preterm newborns have a much
higher risk of morbidity and mortality, in part because of difficulty establishing feeding
and growth. Breastfeeding optimizes the nutrition of these infants by supporting growth and
establishing a healthy intestinal microbiota. However, maternal breast milk production is
often delayed after preterm birth, which can hamper optimal growth. When this occurs,
clinicians may use formula to supplement breastfeeding. However, formula alters neonatal
intestinal microbiota and can impede some of the benefits of a human milk diet. Donor milk
from a certified milk bank could possibly be used instead of formula for supplementation
prior to the onset of copious maternal milk production. However, the use of banked donor milk
has never been studied in late preterm infants. The aim of this proposal is to report the
effects of banked donor milk vs. formula on growth and on intestinal microbiota among late
preterm, breastfeeding newborns who require additional nutrition before copious maternal milk
is available. This study's investigators therefore propose a randomized, controlled trial
enrolling late preterm newborns. Newborns will be randomly assigned either to breastfeed with
additional formula feedings, or to breastfeed with additional donor milk feedings. The
study's outcomes will be: (1) growth (rate of weight change), and (2) intestinal microbiota.
If the study finds that temporary use of donor milk supports growth and maintains healthy
intestinal microbiota until copious maternal milk becomes available, temporary use of donor
milk might be a postnatal strategy to bolster neonatal nutrition and optimize nutritional
support and growth for late preterm infants.
Inclusion Criteria:
- Late preterm newborns >=34 weeks and <37 weeks gestation
- Breastfeeding
- Clinical team plans to start supplementation
Exclusion Criteria:
- Mothers are producing copious breast milk
- Birth weight <2100gm
- Any maternal or infant contraindication to breastfeeding
We found this trial at
1
site
505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
Principal Investigator: Valerie Flaherman, MD,MPH
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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