Back to resultsHigh Energy Formula Feeding in Infants With Congenital Heart Disease
Primary Purpose
Growth Failure, Neurodevelopmental Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High energy formula
Standard formula
Sponsored by
About this trial
This is an interventional supportive care trial for Growth Failure focused on measuring Congenital heart disease, Growth,Neurodevelopment
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
Sites / Locations
- Sami Ulus CHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High energy formula
Standard formula
Arm Description
High energy formula (Similac)
Standard formula
Outcomes
Primary Outcome Measures
Weight gain
Secondary Outcome Measures
Neurodevelopmental evaluation
Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.
Full Information
NCT ID
NCT01850784
First Posted
May 7, 2013
Last Updated
May 8, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01850784
Brief Title
High Energy Formula Feeding in Infants With Congenital Heart Disease
Official Title
High Energy Formula Feeding in Infants With Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Failure, Neurodevelopmental Disorder
Keywords
Congenital heart disease, Growth,Neurodevelopment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High energy formula
Arm Type
Active Comparator
Arm Description
High energy formula (Similac)
Arm Title
Standard formula
Arm Type
Active Comparator
Arm Description
Standard formula
Intervention Type
Dietary Supplement
Intervention Name(s)
High energy formula
Other Intervention Name(s)
High energy formula (Similac)
Intervention Description
The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard formula
Intervention Description
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Neurodevelopmental evaluation
Description
Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Dilli, Assoc Prof
Phone
00903126243
Email
dilekdilli2@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Dilli
Organizational Affiliation
Sami Ulus CH
Official's Role
Study Director
Facility Information:
Facility Name
Sami Ulus CH
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazan N Doğan, MD
First Name & Middle Initial & Last Name & Degree
Nazan N Doğan
12. IPD Sharing Statement
Learn more about this trial
High Energy Formula Feeding in Infants With Congenital Heart Disease
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