Newborn Screening for Critical Congenital Heart Disease

Completed

• Conditions: Congenital Cardiovascular Malformation
• Interventions: Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter

• Registration Number: NCT01765205
• Lead Sponsor: University of Florida

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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)

Exclusion Criteria

• Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborns with Pulse oximetry	Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter	Up to 50 healthy newborn participants will receive 15 minutes of pulse oximetry to determine the effectiveness of measuring somatic oxygen saturation.
CHD infant with pulse oximetry	Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter	Up to 10 infants diagnosed with congenital heart disease will receive 15 minutes of pulse oximetry using the INVOS Cerebral/Somatic Oximeter to determine the effectiveness of measuring somatic oxygen saturation.

Primary Outcome Measures

Name	Time	Method
To measure the oxygen saturation using pulse oximetry.	Baseline	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.

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States