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

Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hypoplastic left heart syndrome

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight gain	5 months

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Martha Clabby, MD, Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 22, 2005
• First Submitted That Met QC Criteria: November 22, 2005
• First Posted (Estimate): November 23, 2005

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Congenital heart disease; Single ventricle; Infant feeding
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Univentricular Heart
• Other Study ID Numbers: IRB00021873