Donor Breast Milk and Breastfeeding Rates

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572581
• Other study ID #: 19-002179
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 15, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive

Intervention

Other:
• Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Santa Monica-UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal Microbiome: microbial profiling (genus level)	Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene	7 days of age
Other	Intestinal Microbiome: alpha diversity (Chao1)	Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene	7 days of age
Primary	Study Feasibility_1	Feasibility will be evaluated by: consent rate	6-8 weeks chronological age
Primary	Study Feasibility_2	Feasibility will be evaluated by: study completion rate	6-8 weeks chronological age
Primary	Study Feasibility_3	Feasibility will be evaluated by: rate of adherence to the study diet.	6-8 weeks chronological age
Secondary	Percentage of Human Milk Consumption at Discharge	Maternal milk/total milk (percent) consumed by the neonate over 48 hours	at the time of NICU discharge or 7 days of age, whichever is later
Secondary	Percentage of Human Milk Consumption After Discharge	Maternal milk/total milk (percent) consumed by the infant over 48 hours	6-8 weeks chronological age
Secondary	Breastfeeding duration	time infant received breastmilk since birth	6-8 weeks chronological age
Secondary	Intent to Breastfeed	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.	6-8 weeks chronological age
Secondary	Growth: Weight	Weight in kilograms reported as a z-score	6-8 weeks chronological age
Secondary	Growth: Height	height in centimeters reported as a z-score	6-8 weeks chronological age
Secondary	Growth: Head Circumference	head circumference in centimeters reported as a z-score	6-8 weeks chronological age