High Energy Formula Feeding in Infants With Congenital Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Dr. Sami Ulus Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier:
NCT01850784
First received: May 7, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Growth Failure
Neurodevelopmental Disorder
Dietary Supplement: High energy formula
Dietary Supplement: Standard formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High Energy Formula Feeding in Infants With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Dr. Sami Ulus Children's Hospital:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopmental evaluation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: High energy formula (Similac)
Active Comparator: Standard formula
Standard formula
Dietary Supplement: Standard formula
The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)
Other Name: 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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850784

Contacts
Contact: Dilek Dilli, Assoc Prof 00903126243 dilekdilli2@yahoo.com

Locations
Turkey
Sami Ulus CH Recruiting
Ankara, Turkey
Contact: Nazan N Doğan, MD         
Sub-Investigator: Nazan N Doğan         
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Study Director: Dilek Dilli Sami Ulus CH
  More Information

No publications provided

Responsible Party: Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01850784     History of Changes
Other Study ID Numbers: 132/2013
Study First Received: May 7, 2013
Last Updated: May 8, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Dr. Sami Ulus Children's Hospital:
Congenital heart disease, Growth,Neurodevelopment

Additional relevant MeSH terms:
Failure to Thrive
Heart Diseases
Heart Defects, Congenital
Growth Disorders
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 24, 2014