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NCT01765205 · ClinicalTrials.gov registry record
Newborn Screening for Critical Congenital Heart Disease
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 20
- Enrollment target
NCT01765205: Completed study, sponsored by University of Florida.
NCT01765205 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01765205 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The oxygen saturation will be measured by pulse oximetry on an infant's skin on the forehead and thigh. These two numbers will be recorded as whole numbers on the machine and will be compared to both groups of infants.
Interventions
- DEVICE Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-01 |
What the finished NCT01765205 record still lists
NCT01765205 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter is the first listed.
NCT01765205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01765205 about?
NCT01765205 is a clinical study titled "Newborn Screening for Critical Congenital Heart Disease". 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 fo...
What is the current status of trial NCT01765205?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01765205?
The interventions under investigation include: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter (DEVICE).
Who is sponsoring clinical trial NCT01765205?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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