Newborn Screening for Critical Congenital Heart Disease
Completed
Conditions studied: Congenital Cardiovascular Malformation
In brief
Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.
Key facts
- Study ID
- NCT01765205
- Run by
- University of Florida
- People needed
- 20
- Starts
- 2010-03-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-03-14
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female subjects aged 12 hours -2 weeks.
- Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
- Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)
You may not qualify if…
- Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Where it is running
- Shands Hospital at the University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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