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Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

NCT04284280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-04-30

No results posted yet for this study

Summary

The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.

Conditions

  • Poor Growth in Extremely Preterm Infants
  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Routine vs Selective use of Human Milk Donor Fortifier

Infants will be randomized to two groups. Both groups will be fed Premature Human Milk (either Maternal own milk or Premature donor human milk). However, one group will get fortified with Donor Human Milk Fortifier once full feed is reached while the second group will get fortified using the same fortifier only when weight gain is suboptimal.

Sponsors & Collaborators

  • Crouse Hospital

    lead OTHER

Principal Investigators

  • Bouraa Bou Aram, MD · Crouse Hospital

  • Swati Murthy, MD · Crouse Hospital

  • Steven J Gross, MD · Crouse Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
6 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2023-10-31
Completion
2025-11-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284280 on ClinicalTrials.gov