High Energy Formula Feeding in Infants With Congenital He... | NCT01850784

Studies
High Energy Formula Feeding in Infants With Congenital Heart Disease

NCT01850784

Sponsor

Dr. Sami Ulus Children's Hospital

Status

Unknown status

Last Update Posted

May 10, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Growth Failure
Neurodevelopmental Disorder

Interventions

High energy formula
Standard formula

Countries

Turkey (Türkiye)

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

May 7, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 9, 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 8, 2013

Last Update Posted Date

May 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's HospitalPrincipal Investigator

Lead Sponsor

Dr. Sami Ulus Children's HospitalOTHER

Collaborators

Not provided

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

High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Detailed Description

Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High energy formula	Active Comparator	High energy formula (Similac)	Dietary Supplement: High energy formula
Standard formula	Active Comparator	Standard formula	Dietary Supplement: Standard formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High energy formula	Dietary Supplement	The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)	High energy formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight gain		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Neurodevelopmental evaluation	Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.	18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants >35 weeks of gestational age
infants with CHD
İnfants fed with formula feeding

Exclusion Criteria:

Major congenital abnormalities except CHD
infants could not be fed enterally

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Days

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dilek Dilli, Assoc Prof	Contact	00903126243		dilekdilli2@yahoo.com

Overall Officials

Name	Affiliation	Role
Dilek Dilli	Sami Ulus CH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sami Ulus CH	Recruiting	Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005183	Failure to Thrive
D065886	Neurodevelopmental Disorders
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders
D018376	Cardiovascular Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided