Tolerance and Compliance of Infants Fed an Hydrolyzed Inf... | NCT01573871

Studies
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

NCT01573871

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

25Actual

Phase

Phase 3

Conditions

Infant
Gastrointestinal Intolerance

Interventions

Experimental Hydrolyzed infant formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Apr 6, 2012

First Submission Date that Met QC Criteria

Apr 6, 2012

First Posted Date

Apr 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrolyzed infant formula	Experimental	Hydrolyzed infant formula to be fed ad libitum	Other: Experimental Hydrolyzed infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Hydrolyzed infant formula	Other	Experimental hydrolyzed infant formula to be fed ad libitum	Hydrolyzed infant formula

Measure	Description	Time Frame
Weight maintenance		14 days

Measure	Description	Time Frame
Formula volume intake		14 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

180 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marlene Borschel, PhD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northpoint Pediatrics		Indianapolis	Indiana	46038	United States
Metro-Health Medical Center