Effects on Growth of an Extensively Hydrolyzed Formula Fe... | NCT00936637

Studies
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

NCT00936637

Sponsor

Perrigo Nutritionals

Status

Completed

Last Update Posted

Jul 10, 2009Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Growth

Interventions

Extensively 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

Jul 2009

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

Jul 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 8, 2009

First Submission Date that Met QC Criteria

Jul 9, 2009

First Posted Date

Jul 10, 2009Estimated

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

Jul 9, 2009

Last Update Posted Date

Jul 10, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extensively hydrolyzed infant formula	Experimental		Other: Extensively hydrolyzed infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extensively hydrolyzed infant formula	Other		Extensively hydrolyzed infant formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants		16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At birth:
- Healthy, term (37-42 weeks) infant
- Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
At time of enrollment:
- < or = 21 days post-natal age
- Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
- Exclusively formula fed
- Written informed consent of parent/guardian

Exclusion Criteria:

At the time of enrollment: partially human-milk fed; fed baby/solid foods
Conditions requiring feedings other than those specified in the protocol
Documented or suspected cow's milk allergy and/or soy protein allergies
Major congenital deformities
Suspected or documented systemic or congenital infections
Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
Participation in any other clinical trial

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

21 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cynthia M Barber, PhD	Perrigo Nutritionals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States