Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Sleep Disordered Breathing in Children With Single Ventricle Physiology
NCT number | NCT00156455 |
Other study ID # | 10185 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | September 8, 2005 |
Last updated | April 29, 2015 |
Start date | September 2004 |
Verified date | April 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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. Elevations in pulmonary vasculature resistance at the time of Stage II surgery.
2. Risks of death
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 2 Years |
Eligibility |
Inclusion Criteria: - Infants with single ventricle physiology Parents who can read and write English Exclusion Criteria: - Infants who are not medically stable Parents who cannot read and write English |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
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