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OpenTrials
Completed

NCT Number: NCT01380886

Growth and Tolerance of Young Infants Fed Infant Formulas

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

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Key information

Conditions

Infant Newborn

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Norwich Pediatric Group, PC, Norwich, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy infant
  • full term
  • birth weight > 2490 g
  • 0 to 8 days of age
  • parent/physician agree to not use medications affecting tolerance/growth
  • parent agrees to sole source feeding of study formula
  • parent agrees to not use vitamin/mineral supplements
  • parent has signed consent/HIPAA authorization

Exclusion criteria

  • any maternal, fetal, or infant history affecting growth and tolerance
  • participation in any other study not preapproved by Abbott

Treatment and study plan

experimental infant formula with alternate protein source

Other

experimental infant formula to be fed ad libitum

Infant formula powder

Other

powdered infant formula to be fed ad libitum

Primary outcomes

  1. Weight gain

    Time frame: 119 days

Secondary outcomes

  1. gastrointestinal tolerance

    Time frame: 119 days

    Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit

  2. Anthropometric variables

    Time frame: 119 days

    Length gain per day and head circumference gain per day

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Feb 15, 2013

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.