Nutritional Study in Preterm Infants

Phase 3

Completed

• Conditions: Preterm Infants
• Interventions: Other: Preterm infant formula with added soluble lipids; Other: Preterm infant formulas and discharge formulas

• Registration Number: NCT00707837
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-01
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2009-04-24
• Last Update Posted: 2009-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

• Serious congenital abnormalities that may affect growth and development
• Grade III or IV intraventricular hemorrhage (IVH)
• Maternal incapacity
• History of major surgery
• Extracorporeal membrane oxygenation (ECMO)
• Asphyxia
• Confirmed NEC or positive blood cultures at the time of randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Formula	Preterm infant formula with added soluble lipids	Preterm infant formulas containing lipid soluble compounds
Preterm formulas	Preterm infant formulas and discharge formulas	Standard preterm infant formula and discharge formulas

Primary Outcome Measures

Name	Time	Method
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	variable

Secondary Outcome Measures

Name	Time	Method
Measures of eye function, ROP, measures of skin lipid soluble compound concentration	variable

Trial Locations

Locations (8)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

West Coast Neonatalogy, All Children's Hospital; 🇺🇸 St. Petersburg, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Maria Fareri Children's Hospital at Winchester Medical Center; 🇺🇸 Vahalla, New York, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

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