Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01573871
First received: April 6, 2012
Last updated: February 14, 2013
Last verified: February 2013

April 6, 2012
February 14, 2013
February 2012
September 2012   (final data collection date for primary outcome measure)
Weight maintenance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01573871 on ClinicalTrials.gov Archive Site
Formula volume intake [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infant
  • Gastrointestinal Intolerance
Other: Experimental Hydrolyzed infant formula
Experimental hydrolyzed infant formula to be fed ad libitum
Experimental: Hydrolyzed infant formula
Hydrolyzed infant formula to be fed ad libitum
Intervention: Other: Experimental 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
25
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infant is 0 to 180 days of age
  • Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
  • Infant has not consumed an extensively hydrolyzed infant formula
  • Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
  • Infant is not receiving steroids.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral during the study

Exclusion Criteria:

• Participation in another study

Both
up to 180 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01573871
AK94
Yes
Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Marlene Borschel, PhD Abbott Nutrition
Abbott Nutrition
February 2013

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