Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Société des Produits Nestlé (SPN)11 sites in 5 countries186 target enrollmentApril 2011

ConditionsPremature Birth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Birth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 186
Locations: 11
Primary Endpoint: Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

March 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
•Male or female
•Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
•Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
•Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria

•Infants with current systemic disease
•Infants with a history of systemic disease
•Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
•Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
•Infants diagnosed with any inherent metabolic disease.
•Infants diagnosed with any chromosomic disease.
•Receiving any commercial formula supplementation to breast milk.
•Receiving steroids at the time of enrollment.
•Participation in another nutritional clinical trial that may affect outcomes of this study.