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Completed

NCT Number: NCT04572581

Donor Breast Milk and Breastfeeding Rates

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

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Key information

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

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About this study

In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age >34 weeks and 0 days
  • Mother's intent to breast feed
  • NICU admission which is predicted to be at least 72 hours from time of admission

Exclusion criteria

  • Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
  • Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
  • Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
  • Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
  • Any infant whose care is considered futile by the primary medical team

Treatment and study plan

Donor Breast Milk

Other

Donor breast milk will be given to the newborn if supplementation is required

Primary outcomes

  1. Study Feasibility_1

    Time frame: 6-8 weeks chronological age

    Feasibility will be evaluated by: consent rate

  2. Study Feasibility_2

    Time frame: 6-8 weeks chronological age

    Feasibility will be evaluated by: study completion rate

  3. Study Feasibility_3

    Time frame: 6-8 weeks chronological age

    Feasibility will be evaluated by: rate of adherence to the study diet.

Secondary outcomes

  1. Percentage of Human Milk Consumption at Discharge

    Time frame: at the time of NICU discharge or 7 days of age, whichever is later

    Maternal milk/total milk (percent) consumed by the neonate over 48 hours

  2. Percentage of Human Milk Consumption After Discharge

    Time frame: 6-8 weeks chronological age

    Maternal milk/total milk (percent) consumed by the infant over 48 hours

  3. Breastfeeding duration

    Time frame: 6-8 weeks chronological age

    time infant received breastmilk since birth

  4. Intent to Breastfeed

    Time frame: 6-8 weeks chronological age

    Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no.

  5. Growth: Weight

    Time frame: 6-8 weeks chronological age

    Weight in kilograms reported as a z-score

  6. Growth: Height

    Time frame: 6-8 weeks chronological age

    height in centimeters reported as a z-score

  7. Growth: Head Circumference

    Time frame: 6-8 weeks chronological age

    head circumference in centimeters reported as a z-score

Other outcomes

  1. Intestinal Microbiome: microbial profiling (genus level)

    Time frame: 7 days of age

    Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene

  2. Intestinal Microbiome: alpha diversity (Chao1)

    Time frame: 7 days of age

    Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2020
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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