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

NCT04284280 | Completed DMC

• 1 other identifier: 2020.0107
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Necrotizing Enterocolitis; Poor Growth in Extremely Preterm Infants

Keywords

Premature Human Milk; Pasteurized Premature Human Milk; Human Milk Donor Fortifier; Neurodevelopmental followup

Outcome Measures

Primary Outcomes (3)

• In-Hospital growth in extremely preterm infants

  Compare the in-hospital growth in extremely preterm infants between routine fortification vs selective fortifications groups

  Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

• Necrotizing Enterocolitis (NEC)

  Compare the difference in the incidence of NEC among the two groups

  Remaining length of NICU admission from the time of randomization (approximately 2 years from recruitment starts)

• Neurodevelopmental outcome

  Assess the difference (if any) in developmental outcome at two years between the two group using Bayley IV

  Assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts)

Secondary Outcomes (1)

• The difference in growth (if any) at two years

  Assessment will be completed at two years adjusted age ( approximately 4 years from the time recruitment starts)

Study Arms (2)

Early Routine Fortification

EXPERIMENTAL

Human Milk Donor Fortifier added to preterm human milk (maternal or donor) when feeds of 150 ml/kg/day are reached (120Kcal/kg/day)

Dietary Supplement: Routine vs Selective use of Human Milk Donor Fortifier

Selective Fortification

ACTIVE COMPARATOR

Human Milk Donor Fortifier added to preterm human milk (maternal or donor) only for weight gain less than 15g/kg/day after full feeds of 180 ml/kg/day are achieved (120 Kcal/kg/day). If milk of any infant in the selective fortification group gets fortified the volume will be decreased to 150 ml/kg/day to keep the total caloric intake equal.

Dietary Supplement: Routine vs Selective use of Human Milk Donor Fortifier

Interventions

Routine vs Selective use of Human Milk Donor Fortifier DIETARY_SUPPLEMENT

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.

Early Routine Fortification; Selective Fortification

Eligibility Criteria

• Age: 0 Days - 6 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding

You may not qualify if:

• Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect

Sponsors & Collaborators

• Crouse Hospital: lead

Study Sites (1)

Crouse Hospital

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Bouraa Bou Aram, MD

  Crouse Hospital

  PRINCIPAL INVESTIGATOR

• Swati Murthy, MD

  Crouse Hospital

  PRINCIPAL INVESTIGATOR

• Steven J Gross, MD

  Crouse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending Physician, Neonatologist

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 25, 2020
• Study Start: February 15, 2020
• Primary Completion: October 31, 2023
• Study Completion: November 11, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)