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Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

NCT02943746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-01-29

No results posted yet for this study

Summary

While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes.

This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW.

There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants.

Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.

Conditions

  • Premature Infants

Interventions

DIETARY_SUPPLEMENT

Standard Protein Diet

Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day.

DIETARY_SUPPLEMENT

High Protein Diet

Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Amy B Hair, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-04-30
Completion
2021-04-30

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 NCT02943746 on ClinicalTrials.gov