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
|Condition or disease|
We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.
If subjects take part in this study, the following will happen:
- Prior to discharge, the parent/guardian will be given a home feeding log and
- 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.
- The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
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|
|Official Title:||Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
- weight gain [ Time Frame: 5 months ]
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
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Martha Clabby, MD||Children's Healthcare of Atlanta|