Nutritional Study in Preterm Infants

Phase 3CompletedNCT00707837

Abbott Nutrition206 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

206

Conditions

Preterm Infants

Interventions

Preterm infant formulas and discharge formulasOTHER

Preterm infant formulas to be consumed per health care provider orders

Preterm infant formula with added soluble lipidsOTHER

Preterm infant formula to be fed per healthcare provider instructions

Eligibility

Sex: ALLMax age: 21 Days

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Measures of eye function, ROP, measures of skin lipid soluble compound concentration

Time frame: variable

Data from ClinicalTrials.gov

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