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Donor Breast Milk and Breastfeeding Rates

Sponsor
University of California, Los Angeles (Other)
Overall Status
Recruiting
CT.gov ID
NCT04572581
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
33.4
Anticipated Duration (Months)
25
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Donor Breast Milk
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exclusively Human Milk Diet

This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.

Other: Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required
No Intervention: Formula-based Diet

If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).

Outcome Measures

Primary Outcome Measures

  1. Study Feasibility_1 [6-8 weeks chronological age]

    Feasibility will be evaluated by: consent rate

  2. Study Feasibility_2 [6-8 weeks chronological age]

    Feasibility will be evaluated by: study completion rate

  3. Study Feasibility_3 [6-8 weeks chronological age]

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

Secondary Outcome Measures

  1. Percentage of Human Milk Consumption at Discharge [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 [6-8 weeks chronological age]

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

  3. Breastfeeding duration [6-8 weeks chronological age]

    time infant received breastmilk since birth

  4. Intent to Breastfeed [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 [6-8 weeks chronological age]

    Weight in kilograms reported as a z-score

  6. Growth: Height [6-8 weeks chronological age]

    height in centimeters reported as a z-score

  7. Growth: Head Circumference [6-8 weeks chronological age]

    head circumference in centimeters reported as a z-score

Other Outcome Measures

  1. Intestinal Microbiome: microbial profiling (genus level) [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) [7 days of age]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 or nasal intermittent mechanical ventilation) and/or ionotropic medications

  • Any infant whose care is considered futile by the primary medical team

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ronald Reagan UCLA Medical Center Los Angeles California United States 90025
2 Santa Monica-UCLA Los Angeles California United States 90404

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

  • Principal Investigator: Kara L Calkins, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kara L. Calkins, MD, Health Sciences Clinical Assistant Professor, Pediatric Neonatology, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04572581
Other Study ID Numbers:
  • 19-002179
First Posted:
Oct 1, 2020
Last Update Posted:
Oct 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kara L. Calkins, MD, Health Sciences Clinical Assistant Professor, Pediatric Neonatology, University of California, Los Angeles
Late Preterm
Donor Breast Milk

Study Results

No Results Posted as of Oct 19, 2021