Nutritional Study in Preterm Infants

This study has been completed.

Sponsor:

Information provided by:

Abbott Nutrition

ClinicalTrials.gov Identifier:

NCT00707837

First received: June 27, 2008

Last updated: April 24, 2009

Last verified: September 2008

Purpose

An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk

Condition	Intervention	Phase
Preterm Infants	Other: Preterm infant formulas and discharge formulas Other: Preterm infant formula with added soluble lipids	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Infant and Newborn Nutrition Premature Babies

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:

The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants [ Time Frame: variable ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measures of eye function, ROP, measures of skin lipid soluble compound concentration [ Time Frame: variable ] [ Designated as safety issue: No ]

Enrollment:	206
Study Start Date:	May 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Infant Formula Preterm infant formulas containing lipid soluble compounds	Other: Preterm infant formula with added soluble lipids Preterm infant formula to be fed per healthcare provider instructions
Active Comparator: Preterm formulas Standard preterm infant formula and discharge formulas	Other: Preterm infant formulas and discharge formulas Preterm infant formulas to be consumed per health care provider orders

Eligibility

Criteria

Inclusion Criteria:

Birthweight 500-1800 g
Less than 33 wks gestational age
Enteral feeding initiated by 21 days of life
Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
Singleton or twin births only
Infant is 21 days of age or less at time of randomization

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707837

Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, United States, 33701
University of South Florida
Tampa, Florida, United States, 33606
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, New York
Maria Fareri Children's Hospital at Winchester Medical Center
Vahalla, New York, United States, 10595
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Abbott Nutrition

Investigators

Study Chair:

Bridget Barrett-Reis, PhD

Abbott Nutrition

More Information

No publications provided

Responsible Party:	Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT00707837 History of Changes
Other Study ID Numbers:	AK15
Study First Received:	June 27, 2008
Last Updated:	April 24, 2009
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013