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Pulse Oximeter Screening in Congenital Heart Disease

NCT ID: NCT02731248

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Congenital Heart Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Prospective screening study

Prospective screening study in newborns

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilek Dilli

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Dilli, Assoc Prof

Role: STUDY_CHAIR

DR sami Ulus Training and Research Hospital

Locations

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Dr Sami Ulus Children Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Bursa Sevket Yılmaz Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Ataturk University Medical Faculty

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Mersin Maternity Hospital

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Mugla Sıtkı Koçman University Medical Faculty

Muğla, , Turkey (Türkiye)

Site Status RECRUITING

Urfa Maternity Hospital

Sanliurfa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dilek Dilli, Assoc Prof

Role: CONTACT

+905422368250

Facility Contacts

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Dilek Dilli, Assoc prof

Role: primary

[email protected]
00903123056000 ext. 6310

Arzu Akdağ, MD

Role: primary

İbrahim Caner, MD

Role: primary

MD

Role: backup

Banu Mutlu, MD

Role: primary

Nilay Hakan, MD

Role: primary

MD

Role: backup

Akan Yaman, MD

Role: primary

MD

Role: backup

Other Identifiers

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SamiUlusCH-CHD

Identifier Type: -

Identifier Source: org_study_id

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