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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
History of Changes
  Purpose

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


Condition Intervention Phase
Infant
Gastrointestinal Intolerance
 Other: Experimental Hydrolyzed infant formula
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight maintenance [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Formula volume intake [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrolyzed infant formula
Hydrolyzed infant formula to be fed ad libitum
 Other: Experimental Hydrolyzed infant formula
Experimental hydrolyzed infant formula to be fed ad libitum

  Eligibility

Ages Eligible for Study:   up to 180 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573871

Locations
United States, Indiana
Northpoint Pediatrics
Indianapolis, Indiana, United States, 46038
United States, Ohio
Metro-Health Medical Center
Cleveland, Ohio, United States, 44109
Ohio Pediatric Research Association
Huber Heights, Ohio, United States, 45424
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene Borschel, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01573871     History of Changes
Other Study ID Numbers: AK94
Study First Received: April 6, 2012
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013