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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
History of Changes

June 27, 2008
April 24, 2009
May 2005
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00707837 on ClinicalTrials.gov Archive Site
Measures of eye function, ROP, measures of skin lipid soluble compound concentration [ Time Frame: variable ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nutritional Study in Preterm Infants
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants

An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Preterm Infants
  • Other: Preterm infant formulas and discharge formulas
    Preterm infant formulas to be consumed per health care provider orders
  • Other: Preterm infant formula with added soluble lipids
    Preterm infant formula to be fed per healthcare provider instructions
  • Experimental: Infant Formula
    Preterm infant formulas containing lipid soluble compounds
    Intervention: Other: Preterm infant formula with added soluble lipids
  • Active Comparator: Preterm formulas
    Standard preterm infant formula and discharge formulas
    Intervention: Other: Preterm infant formulas and discharge formulas
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
up to 21 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00707837
AK15
Yes
Director Clinical Research Operations, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Bridget Barrett-Reis, PhD Abbott Nutrition
Abbott Nutrition
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP