NCT03001479

Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein

Completed NA Last updated 6 May 2023

What this trial tests

NA trial testing Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid in Human Milk in 78 participants. Completed in 1 May 2023.

Timeline

13 March 2017

Primary endpoint
1 May 2020

1 May 2023

Quick facts

Lead sponsor	St. Louis University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	78
Start date	13 March 2017
Primary completion	1 May 2020
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid

Conditions studied

• Human Milk — all drugs for Human Milk →
• Premature Birth of Newborn — all drugs for Premature Birth of Newborn →

Sponsor

St. Louis University

Who can join

Under 2 Weeks, any sex, with Human Milk or Premature Birth of Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the addition of fortifiers to their milk in order to achieve sufficient levels of calories, vitamins, and minerals for adequate growth. We are currently using a liquid human milk fortifier which does not provide sufficient protein intake, requiring addition of a liquid protein supplement. A new product has been released which provides sufficient protein in the liquid HMF, without the acidification seen in previous products.

This is a prospective, randomized noninferiority study comparing the safety and efficacy of the new HMF with additional protein to our current standard of adding additional protein supplementation on top of the HMF.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of different protein concentrations of human milk fortifier for promoting growth and neurological development in preterm infants.
   Gao C, Miller J, Collins CT, Rumbold AR. · · 2020 · cited 9× · PMID 33215474 · DOI 10.1002/14651858.cd007090.pub2