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Pulse Oximeter Screening in Congenital Heart Disease (POX)

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ClinicalTrials.gov Identifier: NCT02731248
Recruitment Status : Unknown
Verified April 2016 by Dilek Dilli, Dr. Sami Ulus Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 7, 2016
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

Brief Summary:
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

Condition or disease Intervention/treatment
Congenital Heart Disease Other: Prospective screening study

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

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Study Type : Observational
Estimated Enrollment : 50000 participants
Time Perspective: Prospective
Official Title: Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases


Intervention Details:
  • Other: Prospective screening study
    Prospective screening study in newborns


Primary Outcome Measures :
  1. pulse oximeter positivity [ Time Frame: 6 months ]
    Congenital heart disease detection by pulse oximeter


Secondary Outcome Measures :
  1. echocardiographic confirmation [ Time Frame: 12 months ]
    echocardiographic confirmation of congenital heart disease



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Babies within the first 24-72 hours followed up in well baby nurseries
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731248


Contacts
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Contact: Dilek Dilli, Assoc Prof +905422368250

Locations
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Turkey
Dr Sami Ulus Children Hospital Recruiting
Ankara, Turkey, 06120
Contact: Dilek Dilli, Assoc prof    00903123056000 ext 6310    dilekdilli2@yahoo.com   
Sub-Investigator: Ayşen Gök, MD         
Bursa Sevket Yılmaz Training and Research Hospital Recruiting
Bursa, Turkey
Contact: Arzu Akdağ, MD         
Ataturk University Medical Faculty Recruiting
Erzurum, Turkey
Contact: İbrahim Caner, MD         
Contact: , MD         
Mersin Maternity Hospital Recruiting
Mersin, Turkey
Contact: Banu Mutlu, MD         
Mugla Sıtkı Koçman University Medical Faculty Recruiting
Mugla, Turkey
Contact: Nilay Hakan, MD         
Contact: , MD         
Urfa Maternity Hospital Recruiting
Urfa, Turkey
Contact: Akan Yaman, MD         
Contact: , MD         
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Study Chair: Dilek Dilli, Assoc Prof DR sami Ulus Training and Research Hospital

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Responsible Party: Dilek Dilli, Assoc Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT02731248     History of Changes
Other Study ID Numbers: SamiUlusCH-CHD
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities