NCT00156455

Brief Summary

This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with:

  1. 1.Elevations in pulmonary vasculature resistance at the time of Stage II surgery.
  2. 2.Risks of death

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

3.5 years

First QC Date

September 8, 2005

Last Update Submit

April 29, 2015

Conditions

Hypoplastic Left Heart SyndromeObstructive Sleep Apnea SyndromeSingle Ventricle Physiology

Keywords

ChildrenHypoplastic left heart syndromeObstructive Sleep Apnea SyndromeSingle Ventricle Physiology

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with hypoplasic heart condition

You may qualify if:

  • Infants with single ventricle physiology Parents who can read and write English

You may not qualify if:

  • Infants who are not medically stable Parents who cannot read and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hypoplastic Left Heart SyndromeSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Heidi V. Connolly, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

March 1, 2008

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

US(1)