Newborn Screening for Critical Congenital Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Cardiovascular Malformation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Newborns with Pulse oximetry

Up to 50 healthy newborn participants will receive 15 minutes of pulse oximetry to determine the effectiveness of measuring somatic oxygen saturation.

Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter

Intervention Type DEVICE

Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.

CHD infant with pulse oximetry

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.

Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter

Intervention Type DEVICE

Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.

Interventions

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Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter

Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.

Intervention Type DEVICE

Other Intervention Names

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Healthy Newborns with Pulse oximetry

Eligibility Criteria

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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)