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Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet

NCT03839173 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-07-29

No results posted yet for this study

Summary

The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier grow according to established guidelines and maintain adequate micronutrient levels.

Conditions

  • Premature Infant
  • Breast Milk Expression

Interventions

OTHER

Human milk based human milk fortifier

A human milk fortifier with added minerals made from donor human milk

Sponsors & Collaborators

  • Neolac Inc dba Medolac Laboratories

    collaborator INDUSTRY

  • Augusta University

    lead OTHER

Principal Investigators

  • Amy Gates, RD · Augusta University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2020-03-31
Completion
2020-03-31

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 NCT03839173 on ClinicalTrials.gov