Comparison of Post-Discharge Growth of Premature Infants... | NCT01759134

Studies
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

NCT01759134

Sponsor

Shaare Zedek Medical Center

Status

Terminated

Last Update Posted

Oct 25, 2013Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Premature Birth of Newborn

Interventions

Post discharge formula

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jan 2, 2012

First Submission Date that Met QC Criteria

Jan 1, 2013

First Posted Date

Jan 2, 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

Oct 24, 2013

Last Update Posted Date

Oct 25, 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

Description Module

Brief Summary

The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Detailed Description

Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Post Discharge Formula	Experimental	Babies will be given formula for first three months post discharge	Other: Post discharge formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Post discharge formula	Other	Babies will be given either materna sensitive or similac neosure	Post Discharge Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
growth	weight (kg), length (cm), head circumference (cm).	3 months post discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
Gestational week 30-34.

Exclusion Criteria:

Congenital major malformation (e.g. congenital heart disease).
Chromosomal abnormality (e.g. Down's syndrome)
Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
Milk allergy
Chronic disease (e.g. oxygen treatment)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Weeks

Maximum Age

34 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alona Bin-Nun, MD	Shaare Zedek Medical Center	Principal Investigator
Cathy Hammerman, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center		Jerusalem			Israel

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