Nutritional Study in Preterm Infants

April 24, 2009 updated by: Abbott Nutrition

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
variable

Secondary Outcome Measures

Outcome Measure
Time Frame
Measures of eye function, ROP, measures of skin lipid soluble compound concentration
Time Frame: variable
variable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (ESTIMATE)

July 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Infants

Clinical Trials on Preterm infant formula with added soluble lipids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe