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

NCT03001479 | Completed DMC

• 1 other identifier: 27563
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Milk; Premature Birth of Newborn

Outcome Measures

Primary Outcomes (3)

• Weight gain, short term

  (grams) in first 30 days on HMF

  30 days

• Length, short term

  (cm) in first 30 days on HMF

  30 days

• Head circumference, short term

  (cm) in first 30 days on HMF

  30 days

Secondary Outcomes (5)

• Weight gain, long term

  36 weeks gestational age or time of hospital discharge

• Length, long term

  36 weeks gestational age or time of hospital discharge

• Head circumference, long term

  36 weeks gestational age or time of hospital discharge

• feeding intolerance

  30 days

• neurodevelopmental outcomes

  18 months corrected gestational age

Study Arms (2)

Standard: Liquid HMF and liquid protein

NO INTERVENTION

This is our standard breast milk fortification in our NICU. One packet (5 mL) of Similac Human Milk Fortifier Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. After infants reach full feedings (160 ml/kg/d), 3 ml/kg of Similac Liquid Protein Fortifier is added (0.5 g/kg protein). This is increased to 6 ml/kg (1 g/kg protein) the next day.

Intervention: HMF Hydrolyzed Protein Concentrated Liquid

EXPERIMENTAL

One packet (5 mL) of Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. Feedings then continue to be advanced to full volume (160 ml/kg/d).

Dietary Supplement: Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid

Interventions

Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid DIETARY_SUPPLEMENT

HMF with additional hydrolyzed protein

Intervention: HMF Hydrolyzed Protein Concentrated Liquid

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very low birth weight, premature infants admitted to the NICU at Cardinal Glennon
• \<32 weeks gestational age and birthweight \<1500 grams
• receiving maternal or donor breast milk

You may not qualify if:

• Infants with an estimated gestational age \>32 weeks OR birthweight \>1500 grams
• Infants who die before fortification of feedings
• Infants receiving formula
• Infants that did not receive feedings with HMF
• Infants transferred to another hospital prior to discharge

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Catherine C Cibulskis, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: December 23, 2016
• Study Start: March 13, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)