Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01765205
Brief 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.
Detailed Description:
This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.
Study:
NCT01765205
Study Brief:
Protocol Section:
NCT01765205