Newborn Screening for Critical Congenital Heart Disease

March 13, 2014 updated by: University of Florida

The Efficacy of 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy newborns and newborns diagnosed with congenital cardiovascular malformations

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.
Other Names:
  • Healthy Newborns with Pulse oximetry
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.
Device: 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.
Other Names:
  • Healthy Newborns with Pulse oximetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the oxygen saturation using pulse oximetry.
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Barry J Byrne, MD, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 118-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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