Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257517
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-11-22
Brief Title:
Multisite Feeding Study Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess 75-100 patients for feeding issues following surgery for single ventricle
Detailed Description:
We wish to consent 75-100 subjects at Childrens Healthcare of Atlanta
If subjects take part in this study the following will happen
1 Prior to discharge the parentguardian 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 childs medical record to obtain other information including diagnosis surgery oxygen saturation levels and medications
4 The parentguardian 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 babys 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 Childrens the primary site for this study
If subjects take part in this study the following will happen
1 Prior to discharge the parentguardian 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 childs medical record to obtain other information including diagnosis surgery oxygen saturation levels and medications
4 The parentguardian 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 babys 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 Childrens the primary site for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None