Pulse Oximeter Screening in Congenital Heart Disease (POX)

April 2, 2016 updated by: Dilek Dilli, Dr. Sami Ulus Children's Hospital

Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Study Type

Observational

Enrollment (Anticipated)

50000

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

  • Turkey
      • Ankara, Turkey, 06120
        • Recruiting
        • Dr Sami Ulus Children Hospital
        • Contact:
        • Sub-Investigator:
          • Ayşen Gök, MD
      • Bursa, Turkey
        • Recruiting
        • Bursa Sevket Yılmaz Training and Research Hospital
        • Contact:
          • Arzu Akdağ, MD
      • Erzurum, Turkey
        • Recruiting
        • Ataturk University Medical Faculty
        • Contact:
          • İbrahim Caner, MD
      • Mersin, Turkey
        • Recruiting
        • Mersin Maternity Hospital
        • Contact:
          • Banu Mutlu, MD
      • Mugla, Turkey
        • Recruiting
        • Muğla Sıtkı Koçman University Medical Faculty
        • Contact:
          • Nilay Hakan, MD
      • Urfa, Turkey
        • Recruiting
        • Urfa Maternity Hospital
        • Contact:
          • Akan Yaman, MD

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

1 day to 5 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Babies within the first 24-72 hours followed up in well baby nurseries

Description

Inclusion Criteria:

  • Babies within the first 24-72 hours followed up in well baby nurseries
  • Babies prior to discharge, if discharged before 24 hours of age,
  • Babies ≤5 days and still followed up in well baby nurseries
  • Babies born ≥35 gestational weeks

Exclusion Criteria:

  • Babies within the first 12 hours of life
  • Babies >5 days of life
  • Babies with a gestational age of >35 weeks
  • Babies with major congenital anomaly except congenial heart disease
  • Babies who had a prenatal diagnosis of congenital heart disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulse oximeter positivity
Time Frame: 6 months
Congenital heart disease detection by pulse oximeter
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
echocardiographic confirmation
Time Frame: 12 months
echocardiographic confirmation of congenital heart disease
12 months

Collaborators and Investigators

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

Sponsor

Dr. Sami Ulus Children's Hospital

Investigators

  • Study Chair: Dilek Dilli, Assoc Prof, DR sami Ulus Training and Research Hospital

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

April 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

April 2, 2016

First Submitted That Met QC Criteria

April 2, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 2, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SamiUlusCH-CHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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