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Completed

NCT Number: NCT01749059

The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.

Completed

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Health Regional Medical Center - Pediatrix Medical Group

Trenton, New Jersey, 08638, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documentation of informed consent and authorization.
  • Full term and late preterm newborns (EGA 35-44 weeks)
  • On room air
  • Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
  • Parents agree to follow-up contact post discharge

Exclusion criteria

  • On supplemental oxygen
  • Admitted to the Neonatal Intensive Care Unit
  • Parents do not agree to follow-up
  • Greater than 30 days of age

Treatment and study plan

Primary outcomes

  1. True Positive Rate

    Time frame: One year follow-up

    The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.

  2. False Positive Rate

    Time frame: One year follow-up

    The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.

  3. True Negative Rate

    Time frame: One year follow-up

    The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.

  4. False Negative Rate

    Time frame: One year follow-up

    The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Registry information

Acronym: CCHD

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2012
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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