Human Milk in Preterm Infants

Not Applicable

• Conditions: Preterm Birth
• Interventions: Dietary Supplement: Human milk fortifier

• Registration Number: NCT05228535
• Lead Sponsor: Augusta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Study Start: 2022-04-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Human milk fortifier	Introducing human milk fortifier at 1 day

Primary Outcome Measures

Name	Time	Method
Growth velocity	at 28 days of life	weight gain in grams/kg/day

Secondary Outcome Measures

Name	Time	Method
Growth velocity	at 36 weeks post menstrual age	weight gain in grams/kg/day

Trial Locations

Locations (1)

Children's Hospital of Georgia; 🇺🇸 Augusta, Georgia, United States