Growth of Preterm Infants Consuming Formula

Société des Produits Nestlé (SPN)9 sites in 1 country150 target enrollmentSeptember 2010

ConditionsGrowth Development Infant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 150
Locations: 9
Primary Endpoint: Growth
Status: Completed
Last Updated: 11 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 a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Exclusively formula-fed
•28-34 weeks GA at birth
•Intact GI tract, tolerating full oral feeds
•Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion Criteria

•Severe respiratory disease defined as needing mechanical ventilation at discharge
•Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
•Major congenital malformation, history of GI surgery, severe postnatal complications
•Daily or routine diuretic use at time of discharge
•Receiving more than 10% of daily kcals from food additives such as thickeners
•Currently participating or having participated in another conflicting clinical trial.

Outcomes

Primary Outcomes

Growth

Time Frame: 4 months

weight gain assessed monthly

Secondary Outcomes

growth, tolerance, morbidity(6 months)
Total body bone mineral content and density and body composition, protein status, and metabolic markers(corrected term and 4 months)