Oxygen Saturation and Perfusion Index ın Neonates at High Altitude

Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude

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.

Study Overview

• Status: Completed
• Conditions: High Altitude; Critical Congenital Heart Disease
• Intervention / Treatment: Other: oxygen saturation and perfusion index screening

• Study Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25100
    • Ataturk University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborns with ≥34 weeks of gestational age

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Establishing normal oxygen saturation and perfusion index values at high altitude	Postnatal 24-48 hours

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Altitude Sickness; Heart Defects, Congenital
• Other Study ID Numbers: B.30.2.ATA.0.01.00/32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No