We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Energy Formula Feeding in Infants With Congenital Heart Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Dilek Dilli, Dr. Sami Ulus Children's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850784
First Posted: May 9, 2013
Last Update Posted: May 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital
  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
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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Neurodevelopmental evaluation [ Time Frame: 18 months ]
    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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: May 7, 2013
First Posted: May 9, 2013
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