Growth of Infants Fed Hydrolysate Formulas | NCT02006992

Studies
Growth of Infants Fed Hydrolysate Formulas

NCT02006992

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

195Actual

Phase

Not Applicable

Conditions

Growth and Tolerance

Interventions

RTF Infant Formula
Powder 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

Dec 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

Mar 2000

Primary Completion Date

Nov 2000Actual

Completion Date

Nov 2000Actual

First Submitted Date

Dec 5, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 10, 2013Estimated

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

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

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

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RTF Infant Formula 1	Active Comparator	a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.	Other: RTF Infant Formula
Powder Infant Formula 2	Experimental	a powdered extensively hydrolyzed infant formula fed ad lib.	Other: Powder Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RTF Infant Formula	Other	a RTF extensively hydrolyzed infant formula	RTF Infant Formula 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight		Study day 1 to 112 days of age

Secondary Outcomes

Measure	Description	Time Frame
Length		Study day 1 to 112 days of age
Head Circumference		Study day 1 to 112 days of age
Study Formula Intake

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants in good health.
Singleton, term birth with a gestational age of 37 to 42 weeks.
Birth weight of 2500 g (5 lb 8 oz) or greater.
Between 0 and 9 days of age at enrollment.
Not receiving vitamin or mineral supplements.

Exclusion Criteria:

- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

9 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, RD, PhD	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas		United States
Dreyer Medical Center