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OpenTrials
Completed

NCT Number: NCT00707837

Nutritional Study in Preterm Infants

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

Completed

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Key information

Conditions

Preterm Infants

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preterm infant formulas and discharge formulas

Other

Preterm infant formulas to be consumed per health care provider orders

Preterm infant formula with added soluble lipids

Other

Preterm infant formula to be fed per healthcare provider instructions

Primary outcomes

  1. 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

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

    Time frame: variable

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 1, 2008
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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