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Completed

NCT Number: NCT00936637

Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.

Completed

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Key information

Conditions

Growth

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At birth:
  • Healthy, term (37-42 weeks) infant
  • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
  • At time of enrollment:
  • < or = 21 days post-natal age
  • Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
  • Exclusively formula fed
  • Written informed consent of parent/guardian

Exclusion criteria

  • At the time of enrollment: partially human-milk fed; fed baby/solid foods
  • Conditions requiring feedings other than those specified in the protocol
  • Documented or suspected cow's milk allergy and/or soy protein allergies
  • Major congenital deformities
  • Suspected or documented systemic or congenital infections
  • Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
  • Participation in any other clinical trial

Treatment and study plan

Extensively hydrolyzed infant formula

Other

Primary outcomes

  1. An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Perrigo Nutritionals

Industry

Registry information

Official study title

A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2009
Registry last updated
Jul 10, 2009

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.

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