NCT01749059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,147

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

4.3 years

First QC Date

December 11, 2012

Last Update Submit

December 16, 2016

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (4)

  • True Positive Rate

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

    One year follow-up

  • False Positive Rate

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

    One year follow-up

  • True Negative Rate

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

    One year follow-up

  • False Negative Rate

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

    One year follow-up

Study Arms (1)

Congenital Heart Defect

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates known to have a congenital heart defect at the time of screening.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health Regional Medical Center - Pediatrix Medical Group

Trenton, New Jersey, 08638, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Reese H Clark, MD

    Pediatrix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Locations

US(1)