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Nutritional Study in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707837
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : April 27, 2009
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Preterm Infants Other: Preterm infant formulas and discharge formulas Other: Preterm infant formula with added soluble lipids Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
Study Start Date : May 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Measures of eye function, ROP, measures of skin lipid soluble compound concentration [ Time Frame: variable ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707837

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
West Coast Neonatalogy, All Children's Hospital
St. Petersburg, Florida, United States, 33701
University of South Florida
Tampa, Florida, United States, 33606
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, New York
Maria Fareri Children's Hospital at Winchester Medical Center
Vahalla, New York, United States, 10595
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Bridget Barrett-Reis, PhD Abbott Nutrition

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Responsible Party: Director Clinical Research Operations, Abbott Nutrition Identifier: NCT00707837     History of Changes
Other Study ID Numbers: AK15
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: September 2008

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications