Human Milk in Preterm Infants

Augusta University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Birth

Interventions

Human milk fortifierDIETARY_SUPPLEMENT

Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds

Eligibility

Sex: ALLMax age: 4 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Georgia

Augusta, Georgia, United States

RECRUITING

Outcomes

Primary Outcomes

Growth velocity

weight gain in grams/kg/day

Time frame: at 28 days of life

Secondary Outcomes

Growth velocity

weight gain in grams/kg/day

Time frame: at 36 weeks post menstrual age

Central Contacts

Zanna Wynter, DO

CONTACT

770-608-0868 zwynter@augusta.edu

Data from ClinicalTrials.gov

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