Donor Breast Milk and Breastfeeding Rates

Not Applicable

Completed

• Conditions: Breastfeeding, Exclusive; Breastfeeding
• Interventions: Other: Donor Breast Milk

• Registration Number: NCT04572581
• Lead Sponsor: University of California, Los Angeles

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.

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 Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-10-01
• Study Start: 2020-11-01
• Primary Completion: 2022-06-26
• Status Verified: 2022-08
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exclusively Human Milk Diet	Donor Breast Milk	This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.

Primary Outcome Measures

Name	Time	Method
Study Feasibility_2	6-8 weeks chronological age	Feasibility will be evaluated by: study completion rate
Study Feasibility_3	6-8 weeks chronological age	Feasibility will be evaluated by: rate of adherence to the study diet.
Study Feasibility_1	6-8 weeks chronological age	Feasibility will be evaluated by: consent rate

Secondary Outcome Measures

Name	Time	Method
Growth: Height	6-8 weeks chronological age	height in centimeters reported as a z-score
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
Percentage of Human Milk Consumption After Discharge	6-8 weeks chronological age	Maternal milk/total milk (percent) consumed by the infant over 48 hours
Growth: Head Circumference	6-8 weeks chronological age	head circumference in centimeters reported as a z-score
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.
Breastfeeding duration	6-8 weeks chronological age	time infant received breastmilk since birth
Growth: Weight	6-8 weeks chronological age	Weight in kilograms reported as a z-score

Trial Locations

Locations (2)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Santa Monica-UCLA; 🇺🇸 Los Angeles, California, United States