|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00936637 |
|
Date of registration:
|
08/07/2009 |
|
Primary sponsor: |
|
|
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 |
|
URL:
|
http://clinicaltrials.gov/show/NCT00936637 |
|
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
| | | | | | | |
|
Contacts
|
|
Name:
|
Cynthia M Barber, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
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
diseases
- Participation in any other clinical trial
Age minimum:
N/A
Age maximum:
21 Days
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Growth
|
|
Intervention(s)
|
|
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 ID(s)
|
|
UVA Growth Study
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|