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Novel Human Milk Based Human Milk Fortifier

NCT04478487 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-17

No results posted yet for this study

Summary

The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).

Conditions

  • Infant, Premature, Diseases

Interventions

DIETARY_SUPPLEMENT

Medolac human milk based human milk fortifier (MHMHMF)

MHMHMF is admixed with expressed or donor human milk in graded doses according to tolerated feed volume according to established guidelines and maintain adequate micronutrient levels.

Sponsors & Collaborators

  • Neolac Inc dba Medolac Laboratories

    collaborator INDUSTRY

  • Northwest Health

    lead OTHER

Principal Investigators

  • Sean Fels · Medolac Laboratories

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2024-09-30
Completion
2024-09-30

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 NCT04478487 on ClinicalTrials.gov