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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:


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

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014