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High Energy Formula Feeding in Infants With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT01850784
Recruitment Status : Unknown
Verified May 2013 by Dilek Dilli, Dr. Sami Ulus Children's Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2013
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

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

Condition or disease Intervention/treatment Phase
Growth Failure Neurodevelopmental Disorder Dietary Supplement: High energy formula Dietary Supplement: Standard formula Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High Energy Formula Feeding in Infants With Congenital Heart Disease
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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 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)



Primary Outcome Measures :
  1. Weight gain [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Neurodevelopmental evaluation [ Time Frame: 18 months ]
    Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Neurodevelopmental Disorders
Failure to Thrive
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Mental Disorders
Signs and Symptoms