Infant Formula Supplemented With a Special Fat Formulatio... | NCT01140243

Studies
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

NCT01140243

Sponsor

Materna Laboratories

Status

Completed

Last Update Posted

May 29, 2013Estimated

Enrollment

31Actual

Phase

Not Applicable

Conditions

Premature Infants

Interventions

LCPUFA

Countries

Israel

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

Apr 2012

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 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

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 27, 2013

Last Update Posted Date

May 29, 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

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test product	Experimental	Dietary supplement	Dietary Supplement: LCPUFA
standart	Active Comparator	Dietary supplement	Dietary Supplement: LCPUFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LCPUFA	Dietary Supplement	premature infant formula supplemented with LCPUFA	standart test product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anthropometric	anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
whose mothers are unable to breast feed or have chosen not to breast feed,
Whose parents have signed the informed consent form.
Only the first among twins will be recorded for the study.

Exclusion Criteria:

Chromosomal abnormalities or congenital malformation.
Metabolic abnormalities.
Central nervous system abnormalities.
Severe developmental disorders.
GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
Milk allergy or intolerance.
Growth failure.
Chronic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

6 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal Intensive Care Unit, Barzilai Medical Center		Ashkelon			Israel
Sharei Zedek MC

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided