Newborn Screening for Critical Congenital Heart Disease

Last updated: March 13, 2014
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

Birth Defects

Holoprosencephaly

Treatment

N/A

Clinical Study ID

NCT01765205
IRB 118-2010
  • Ages < 2
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects aged 12 hours -2 weeks.

  • Newborns with identified congenital heart disease or newborns without identifiedcongenital heart disease.

  • Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR);Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical AorticStenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 20
Study Start date:
March 01, 2010
Estimated Completion Date:
January 31, 2014

Study 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.

Connect with a study center

  • Shands Hospital at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

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