Pulse Oximeter Screening in Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— POX  

Official title:

Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731248
• Other study ID #: SamiUlusCH-CHD
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2016
• Last updated: April 2, 2016
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: April 2016
• Source: Dr. Sami Ulus Children's Hospital
• Contact: Dilek Dilli, Assoc Prof
• Phone: +905422368250
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Prospective screening study
Prospective screening study in newborns

Locations

Country	Name	City	State
Turkey	Dr Sami Ulus Children Hospital	Ankara
Turkey	Bursa Sevket Yilmaz Training and Research Hospital	Bursa
Turkey	Ataturk University Medical Faculty	Erzurum
Turkey	Mersin Maternity Hospital	Mersin
Turkey	Mugla Sitki Koçman University Medical Faculty	Mugla
Turkey	Urfa Maternity Hospital	Urfa

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse oximeter positivity	Congenital heart disease detection by pulse oximeter	6 months	No
Secondary	echocardiographic confirmation	echocardiographic confirmation of congenital heart disease	12 months	No