Evaluation of Two Human Milk Fortifiers in Preterm Infants

Abbott Nutrition18 sites in 1 country164 target enrollmentDecember 2014

ConditionsInfant Growth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Growth
Sponsor: Abbott Nutrition
Enrollment: 164
Locations: 18
Primary Endpoint: Weight Gain
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

February 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Birth weight of 700 g-1500 g.
•≤ 32 weeks and 0 days GA at birth.
•Appropriate for GA (AGA).
•Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
•Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
•Parent(s) agrees to allow infant to receive both human milk and HMF.
•Singleton or twin births only.

Exclusion Criteria

•Enteral feeding of preterm infant formula or HMF for \> 7 days.
•Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
•Serious congenital abnormalities or underlying disease that may affect growth and development.
•5 minute APGAR ≤
•Steroids used at the time of randomization.
•Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
•Mechanical ventilator dependence.
•Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
•Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
•Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).

Outcomes

Primary Outcomes

Weight Gain

Time Frame: Study Day 1 to Study Day 29 (or discharge, whichever happens first)

scale measurement g/kg/d

Secondary Outcomes

Gastrointestinal Tolerance(Study Day 1 to Study Day 29 (or discharge, whichever happens first))
Length(Study Day 1 to Study Day 29 (or discharge, whichever happens first))
Head Circumference(Study Day 1 to Study Day 29 (or discharge, whichever happens first))