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NCT00707837 Clinical Trial

Nutritional Study in Preterm Infants

Preterm Infants Clinical Trial

Official title:
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00707837
Other study ID # AK15
Secondary ID
Status Completed
Phase Phase 3
First received June 27, 2008
Last updated April 24, 2009
Start date May 2005
Est. completion date August 2008

Study information
Verified date September 2008
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 206
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Days
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Other:
• Preterm infant formulas and discharge formulas
Preterm infant formulas to be consumed per health care provider orders
• Preterm infant formula with added soluble lipids
Preterm infant formula to be fed per healthcare provider instructions

Locations
Country Name City State
United States University of Alabama Birmingham Alabama
United States MetroHealth Medical Center Cleveland Ohio
United States University of Louisville Louisville Kentucky
United States Women & Infants Hospital of Rhode Island Providence Rhode Island
United States University of Utah Salt Lake City Utah
United States West Coast Neonatalogy, All Children's Hospital St. Petersburg Florida
United States University of South Florida Tampa Florida
United States Maria Fareri Children's Hospital at Winchester Medical Center Vahalla New York

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Measures of eye function, ROP, measures of skin lipid soluble compound concentration variable No
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