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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00936637
Date of registration: 08/07/2009
Primary sponsor: PBM Products
Public title: Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
Scientific 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.
Date of first enrolment: July 2007
Target sample size: 35
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver)  
Countries of recruitment
United States
Name:   Cynthia M Barber, PhD
Affiliation:  PBM Products
Key inclusion & exclusion criteria

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

- Participation in any other clinical trial

Age minimum: N/A
Age maximum: 21 Days
Gender: Both
Health Condition(s) or Problem(s) studied
Other: Extensively hydrolyzed infant formula
Primary Outcome(s)
An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants [Time Frame: 16 weeks]
Secondary Outcome(s)
Secondary ID(s)
UVA Growth Study
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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