Oxygen Saturation and Perfusion Index ın Neonates at High Altitude

High Altitude Clinical Trial

Official title:

Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290481
• Other study ID #: B.30.2.ATA.0.01.00/32
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital heart diseases are among the most common congenital anomalies and occur with an incidence of approximately 8ınd12 / 1,000 live births worldwide. This figure does not cover minor lesions such as bicuspid aortic valves and small atrial or ventricular septal defects. Most of these defects do not need treatment or treatment is needed after infancy. Other defects are severe and usually require early treatment in the neonatal period. Critical congenital heart disease is defined as structural heart defects that are associated with hypoxia in the neonatal period and have significant morbidity and mortality potential in early life. Critical congenital heart disease is estimated to be ~3 in 1000 live births. It is estimated that 50% of congenital heart diseases are detected by prenatal ultrasound. Even if a standard neonatal examination is performed, 13 to 55% of patients with critical congenital heart disease can be discharged from the hospital without being diagnosed.

Screening of infants with non-invasive oxygen saturation measurement has been proposed as an adjunct to early detection of critical congenital heart disease.

The American Academy of Pediatrics, the American Cardiology Foundation and the American Heart Association have targeted 7 specific lesions for the pulse oximetry screening protocol: truncus arteriosus, transposition of the great arteries, tricuspid atresia, tetralogy of Fallot, total pulmonary venous return anomaly, hypoplastic left heart syndrome and pulmonary atresia.

The reference values of peripheral perfusion (PPI) index has been established for normal newborns between 1 and 120 h of age.

Lower PPI values than 0.70 may indicate illness. Including cut-off values for PPI in pulse-oximetry screening for duct dependent congenital heart disease is a promising tool for improving the detection of critical congenital heart disease with duct-dependent systemic circulation.

We aimed to investigate screening critical congenital heart disease and also to establish normal values of oxygen saturation and perfusion index at high altitude.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

Inclusion Criteria:

• The newborns delivered in Ataturk University Hospital and =34 weeks of gestational age were eligible for the study.

Exclusion Criteria:

• Outborn and premature babies (<34 weeks) were not included. Babies with a prenatal diagnosis of congenital heart disease were excluded.

Related Conditions & MeSH terms

• Altitude Sickness
• Critical Congenital Heart Disease
• Heart Diseases
• High Altitude

Intervention

Other:
• oxygen saturation and perfusion index screening
Oxygen saturation and perfusion index values that are measured by pulse oximeter is used for screening critical congenital heart disease.

Locations

Country	Name	City	State
Turkey	Ataturk University Medical Faculty	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishing threshold values for critical congenital heart disease screening at high altitude	We aim to explore whether oxygen saturation and perfusion index threshold values are different compared sea level or not.	Postnatal 24-48 hours
Secondary	Establishing normal oxygen saturation and perfusion index values at high altitude		Postnatal 24-48 hours