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NCT00936637 Clinical Trial

Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

Growth Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00936637
Other study ID # UVA Growth Study
Secondary ID
Status Completed
Phase N/A
First received July 8, 2009
Last updated July 9, 2009
Start date July 2007
Est. completion date December 2008

Study information
Verified date July 2009
Source Perrigo Nutritionals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 21 Days
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

Intervention

Other:
• Extensively hydrolyzed infant formula

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
Perrigo Nutritionals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants 16 weeks No
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