High Energy Formula Feeding in Infants With Congenital Heart Disease

May 8, 2013 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Sami Ulus CH
        • Contact:
          • Nazan N Doğan, MD
        • Sub-Investigator:
          • Nazan N Doğan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High energy formula
High energy formula (Similac)
Dietary supplement: High energy formula
The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
Other Names:
  • High energy formula (Similac)
Active Comparator: Standard formula
Dietary supplement: Standard formula
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Sami Ulus Children's Hospital

Investigators

  • Study Director: Dilek Dilli, Sami Ulus CH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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