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NCT05228535 Clinical Trial

Human Milk in Preterm Infants

Preterm Birth Clinical Trial

Official title:
Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05228535
Other study ID # 1813934-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2022
Est. completion date December 2023

Study information
Verified date July 2022
Source Augusta University
Contact Zanna Wynter, DO
Phone 770-608-0868
Email zwynter@augusta.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Days
Eligibility Inclusion Criteria: - Birth weight 1000-1500 grams - Admitted to NICU within 24 hours of life - Maternal intent to use human milk Exclusion Criteria: - Congenital anomalies - Feeds not started within the first 96 hours of life - Intrauterine growth restriction

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Human milk fortifier
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds

Locations
Country Name City State
United States Children's Hospital of Georgia Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth velocity weight gain in grams/kg/day at 28 days of life
Secondary Growth velocity weight gain in grams/kg/day at 36 weeks post menstrual age
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