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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014