search
Back to results

Nutritional Study in Preterm Infants

Primary Purpose

Preterm Infants

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Preterm infant formulas and discharge formulas
Preterm infant formula with added soluble lipids
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants

Eligibility Criteria

undefined - 21 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • West Coast Neonatalogy, All Children's Hospital
  • University of South Florida
  • University of Louisville
  • Maria Fareri Children's Hospital at Winchester Medical Center
  • MetroHealth Medical Center
  • Women & Infants Hospital of Rhode Island
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Infant Formula

Preterm formulas

Arm Description

Preterm infant formulas containing lipid soluble compounds

Standard preterm infant formula and discharge formulas

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2008
Last Updated
April 24, 2009
Sponsor
Abbott Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT00707837
Brief Title
Nutritional Study in Preterm Infants
Official Title
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infant Formula
Arm Type
Experimental
Arm Description
Preterm infant formulas containing lipid soluble compounds
Arm Title
Preterm formulas
Arm Type
Active Comparator
Arm Description
Standard preterm infant formula and discharge formulas
Intervention Type
Other
Intervention Name(s)
Preterm infant formulas and discharge formulas
Intervention Description
Preterm infant formulas to be consumed per health care provider orders
Intervention Type
Other
Intervention Name(s)
Preterm infant formula with added soluble lipids
Intervention Description
Preterm infant formula to be fed per healthcare provider instructions
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Measures of eye function, ROP, measures of skin lipid soluble compound concentration
Time Frame
variable

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Barrett-Reis, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
West Coast Neonatalogy, All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maria Fareri Children's Hospital at Winchester Medical Center
City
Vahalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Nutritional Study in Preterm Infants

We'll reach out to this number within 24 hrs