Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

February 14, 2013 updated by: Abbott Nutrition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46038
        • Northpoint Pediatrics
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Metro-Health Medical Center
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatric Research Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight maintenance
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Formula volume intake
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene Borschel, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AK94

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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