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The Milk, Growth and Microbiota Study (MGM)

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ClinicalTrials.gov Identifier: NCT03220282
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : September 28, 2021
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE July 7, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE October 30, 2017
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
Weight change [ Time Frame: Between enrollment and 24 hours after enrollment ]
Grams
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Bifidobacteria [ Time Frame: 1 week and 1 month after enrollment ]
    Abundance
  • Lactobacillus [ Time Frame: 1 week and 1 month after enrollment ]
    Abundance
  • Clostridium [ Time Frame: 1 week and 1 month after enrollment ]
    Abundance
  • Weight change [ Time Frame: Between enrollment and 48 hours after enrollment ]
    Grams
  • Weight change [ Time Frame: Between enrollment and 7 days of age ]
    Grams
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Milk, Growth and Microbiota Study
Official Title  ICMJE Milk, Growth and Microbiota: A Randomized, Controlled Trial (RCT) of Donor Milk vs. Formula to Supplement Breastfeeding Late Preterm Newborns
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial with 2 arms
Masking: Single (Outcomes Assessor)
Masking Description:
Participant, PI, enrolling nurse and clinical care team will not be blinded as to treatment assignment. Outcomes will be assessed by blinded investigators.
Primary Purpose: Prevention
Condition  ICMJE
  • Preterm Infant
  • Growth Delay
  • Microbial Colonization
  • Breastfeeding
  • Breast Milk Substitute Intolerance
Intervention  ICMJE
  • Other: Donor milk
    For late preterm newborns who are breastfeeding and whose mothers are not making enough breast milk yet to meet their nutritional needs, the study will compare the intervention of banked donor breast milk with the control of preterm infant formula.
    Other Name: Donor breast milk
  • Other: Preterm infant formula
    Preterm formula determined by clinical practice
    Other Name: Formula
Study Arms  ICMJE
  • Active Comparator: Donor milk
    Pasteurized donor breast milk
    Intervention: Other: Donor milk
  • Placebo Comparator: Preterm infant formula
    Preterm formula determined by clinical practice
    Intervention: Other: Preterm infant formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 96 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valerie Flaherman, MD, MPH 415-502-6166 Valerie.Flaherman@ucsf.edu
Contact: Michelle Rait, RN 415-502-1594 michelle.rait@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03220282
Other Study ID Numbers  ICMJE 17-21587
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The final data set will include information on infant weight and intestinal microbiota, as well as data on other clinical and demographic variables. Once the study has concluded and the data has been de-identified, the investigators will share the de-identified data with other users who agree to a data sharing plan that limits use of the data to research purposes only, excludes any use of the data to identify individual participants and destroys the data once the proposed research has been completed.
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE University of California, Davis
Investigators  ICMJE
Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP