Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

This study has been completed.
Sponsor:
Information provided by:
PBM Products
ClinicalTrials.gov Identifier:
NCT00936637
First received: July 8, 2009
Last updated: July 9, 2009
Last verified: July 2009

July 8, 2009
July 9, 2009
July 2007
December 2008   (final data collection date for primary outcome measure)
An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00936637 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
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.

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Growth
Other: Extensively hydrolyzed infant formula
Experimental: Extensively hydrolyzed infant formula
Intervention: Other: Extensively hydrolyzed infant formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 21 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00936637
UVA Growth Study
No
Cynthia Barber, PhD; Vice President of Regulatory, Medical and Clinical Affairs, PBM Products
PBM Products
Not Provided
Study Director: Cynthia M Barber, PhD PBM Products
PBM Products
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP