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Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

This study is currently recruiting participants.
Verified by Emory University, July 2008

Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00257517
  Purpose

This study will assess 75-100 patients for feeding issues following surgery for single ventricle.


Condition
Congenital Disorders

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

Further study details as provided by Emory University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   100
Study Start Date:   October 2005
Estimated Study Completion Date:   June 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Detailed Description:

We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.

If subjects take part in this study, the following will happen:

  1. Prior to discharge, the parent/guardian will be given a home feeding log and
  2. Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
  3. The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
  4. The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:

    • First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
    • Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
    • Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.

It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.

The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.

  Eligibility
Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

hypoplastic left heart syndrome


Criteria

Inclusion Criteria:

  • Single ventricle patients who have received the Norwood Stage I operation.

Exclusion Criteria:

  • Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis [NEC] or other gastrointestinal [GI] anomalies)
  • Prematurity less than 37 weeks
  • Infants greater than 30 days of age at Stage I palliation
  • Parents who cannot read or understand questionnaires administered as a part of the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257517

Contacts
Contact: Martha Clabby, MD     404.785.1716     clabbym@kidsheart.com    

Locations
United States, Georgia
Children's Healthcare of Atlanta     Recruiting
      Atlanta, Georgia, United States, 30322
      Sub-Investigator: Marsha Elixson, RN, MS            
      Sub-Investigator: Gillian Hide, RN            
      Sub-Investigator: Lisa Pugsley, RN, MSN            

Sponsors and Collaborators
Emory University

Investigators
Principal Investigator:     Martha Clabby, MD     Children's Healthcare of Atlanta    
  More Information


Responsible Party:   Emory University Institutional Review Board ( Chairman )
Study ID Numbers:   1055-2005
First Received:   November 22, 2005
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00257517
Health Authority:   United States: Institutional Review Board

Keywords provided by Emory University:
Congenital heart disease  
Single ventricle  
Infant feeding  

Study placed in the following topic categories:
Heart Diseases
Single ventricular heart

ClinicalTrials.gov processed this record on September 19, 2008




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