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NCT00327977 · ClinicalTrials.gov registry record
Hypoxemia in Infants After Palliative Surgery
A clinical trial, sponsored by Children's Healthcare of Atlanta.
- Completed
- Registry status
- 375
- Enrollment target
NCT00327977: Completed study, sponsored by Children's Healthcare of Atlanta.
NCT00327977 is a clinical trial that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 375 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00327977 has completed, sponsored by Children's Healthcare of Atlanta.
- COMPLETED
- Registry status
- 375 participants
- Enrollment target
Study Summary
Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac defects require surgical palliation or repair in the newborn period. The effects of chronic hypoxia on growth and development are unclear. Infants with very severe cardiac defects may undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not correction. As a result, these infants are exposed to a physiology of chronic hypoxia during the neonatal period through infancy, a critical period of growth and development. The optimal oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this study is to analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference during the first three years of life.
Primary Outcome
Ongoing data analysis of risk factors for death in the high risk population has revealed that some aspects of the clinical course of these patients which are new to the field. Episodes of decomposition may not have been sudden as previously thought, but may have been preceded by some mild signs of change in cardiovascular status. This may in fact have led to changes in clinical course that were undetected because this was a new clinical finding.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2001-01 |
| Est. Completion | 2011-02 |
What the finished NCT00327977 record still lists
NCT00327977 is an observational study that tracks outcomes without assigning an intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00327977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00327977 about?
NCT00327977 is a clinical study titled "Hypoxemia in Infants After Palliative Surgery". Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac defects require surgical palliation or repair in the newborn period. The effects of chronic hypoxia on growth and development are unclear. Infants with very severe cardiac defects may undergo surgery in inf...
What is the current status of trial NCT00327977?
This trial is currently completed. The enrollment target is 375 participants. The study started on 2001-01. Estimated completion is 2011-02.
Who is sponsoring clinical trial NCT00327977?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
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