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

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.
ClinicalTrials.gov Identifier: NCT00257517
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Martha L. Clabby, MD, Emory University

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

Condition or disease
Congenital Disorders

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.


Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
Study Start Date : October 2005
Primary Completion Date : January 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. weight gain [ Time Frame: 5 months ]


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 30 Days   (Child)
Sexes Eligible for Study:   All
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.

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): NCT00257517


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Martha Clabby, MD Children's Healthcare of Atlanta

Responsible Party: Martha L. Clabby, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00257517     History of Changes
Other Study ID Numbers: IRB00021873
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Martha L. Clabby, MD, Emory University:
Congenital heart disease
Single ventricle
Infant feeding