Preterm Infant Growth

Growth Clinical Trial

Official title:

Growth of Preterm Infants Consuming Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162798
• Other study ID #: 09.02.US.INF
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: November 3, 2014
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Development
• Growth
• Infant

Intervention

Other:
• infant formula
test infant formula fed to infants until 6 months corrected gestational age
• control infant formula
commercially available infant formula

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Iowa	Iowa City	Iowa
United States	Midatlantic Neonatology Associates, Inc	Morristown	New Jersey
United States	Children's Hospital & Research Center	Oakland	California
United States	Center for Human Nutrition	Omaha	Nebraska
United States	Advocate Lutheran Children's Hospital	Park Ridge	Illinois
United States	VCU Children's Medical Center	Richmond	Virginia
United States	University of Utah, Dept of Pediatrics	Salt Lake City,	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	weight gain assessed monthly	4 months	No
Secondary	growth, tolerance, morbidity	gains in length and head circumference assessed monthly, tolerance and morbidity throughout study	6 months	No
Secondary	Total body bone mineral content and density and body composition, protein status, and metabolic markers		corrected term and 4 months	No