Tolerance of an Extensively Hydrolyzed Protein Infant For... | NCT01987154

Studies
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

NCT01987154

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Feeding Intolerance

Interventions

Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formula

Countries

Italy

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

May 2016

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 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 12, 2013

First Posted Date

Nov 19, 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

May 16, 2016

Last Update Posted Date

May 17, 2016Estimated

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

Description Module

Brief Summary

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Detailed Description

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Marketed cow milk-based premature infant formula	Active Comparator		Other: Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formula	Experimental		Other: Marketed extensively hydrolyzed casein infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Marketed cow milk-based premature infant formula	Other		Marketed cow milk-based premature infant formula
Marketed extensively hydrolyzed casein infant formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enteral intake (ml/kg/day)		Daily for 14 days

Secondary Outcomes

Measure	Description	Time Frame
Body Weight (g)		Daily for 14 days
Feeding Tolerance	Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)	Daily for 14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premature infant 28 to 33 weeks gestational age, inclusive, at birth
Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
Birth weight is greater than or equal to 700g to 1750g
Appropriate birth weight for gestational age
Singleton or twin birth
Signed Informed consent

Exclusion Criteria:

Infant's mother plans to exclusively breast feed
5 minute APGAR score is less than or equal to 4
Major surgery that required general anesthesia prior to randomization
Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
Infant is currently participating in another clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariella Baldassarre, M.D.	Universita degli Studi di Bari	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari		Bari	Apulia	70124	Italy