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CompletedNCT00707837Updated Apr 27, 2009

Nutritional Study in Preterm Infants

A Phase 3 interventional study of Preterm infant formulas and discharge formulas and Preterm infant formula with added soluble lipids in Preterm Infants, sponsored by Abbott Nutrition. Completed at 8 sites in United States. Open to participants aged Up to 21 Days. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by Abbott Nutrition (part of Abbott) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
Up to 21 Days
Sex
All
01

Study summary

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

02

Conditions studied

  • Preterm Infants
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 21 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
206 participants (actual)

Study arms

  • Experimental
    Infant Formula

    Preterm infant formulas containing lipid soluble compounds

    Other: Preterm infant formula with added soluble lipids

  • Active comparator
    Preterm formulas

    Standard preterm infant formula and discharge formulas

    Other: Preterm infant formulas and discharge formulas

Interventions

  • OtherPreterm infant formulas and discharge formulas

    Preterm infant formulas to be consumed per health care provider orders

  • OtherPreterm infant formula with added soluble lipids

    Preterm infant formula to be fed per healthcare provider instructions

06

What researchers measure

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

07

Study locations

8 sites
  • University of Alabama
    Birmingham, Alabama 35233, United States
  • West Coast Neonatalogy, All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • University of South Florida
    Tampa, Florida 33606, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Maria Fareri Children's Hospital at Winchester Medical Center
    Vahalla, New York 10595, United States
  • MetroHealth Medical Center
    Cleveland, Ohio 44109, United States
  • Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02905, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2005, a primary completion of Aug 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2008
First posted
Jul 1, 2008
Start
May 2005
Primary completionActual
Aug 2008
CompletionActual
Aug 2008
Last update
Apr 27, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00707837
Lead sponsor
Abbott Nutrition
First posted
Jul 1, 2008
Start date
May 2005
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Apr 27, 2009

Study contacts

Bridget Barrett-Reis, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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