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

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

Time frame: 16 weeks

Interested in participating?

Completed

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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.

Published trials that share one or more normalized conditions with this study.

Completed