NCT00257517

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

4.3 years

First QC Date

November 22, 2005

Last Update Submit

February 11, 2014

Conditions

Congenital Disorders

Keywords

Congenital heart diseaseSingle ventricleInfant feeding

Outcome Measures

Primary Outcomes (1)

  • weight gain

    5 months

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

hypoplastic left heart syndrome

You may qualify if:

  • Single ventricle patients who have received the Norwood Stage I operation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Defects, CongenitalUniventricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • Martha Clabby, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

October 1, 2005

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

US(1)