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

Congenital Disorders Clinical Trial

Official title:

Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257517
• Other study ID #: IRB00021873
• Status: Completed
• Phase: N/A
• First received: November 22, 2005
• Last updated: February 11, 2014
• Start date: October 2005
• Est. completion date: June 2010

Study information

• Verified date: February 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain		5 months	No