Preterm Infant Growth

Not Applicable

Completed

• Conditions: Infant; Growth; Development
• Interventions: Other: control infant formula; Other: infant formula

• Registration Number: NCT01162798
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-09
• Primary Completion: 2013-10
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Born AGA
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control infant formula	commercially available formula
Test	infant formula	test formula

Primary Outcome Measures

Name	Time	Method
Growth	4 months	weight gain assessed monthly

Secondary Outcome Measures

Name	Time	Method
growth, tolerance, morbidity	6 months	gains in length and head circumference assessed monthly, tolerance and morbidity throughout study
Total body bone mineral content and density and body composition, protein status, and metabolic markers	corrected term and 4 months

Trial Locations

Locations (9)

Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

Midatlantic Neonatology Associates, Inc; 🇺🇸 Morristown, New Jersey, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Advocate Lutheran Children's Hospital; 🇺🇸 Park Ridge, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Children's Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States

Children's Hospital & Research Center; 🇺🇸 Oakland, California, United States

University of Utah, Dept of Pediatrics; 🇺🇸 Salt Lake City,, Utah, United States

VCU Children's Medical Center; 🇺🇸 Richmond, Virginia, United States