Oxygen Saturation and Perfusion Index ın Neonates at High Altitude

NCT04290481 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/32
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Congenital Heart Disease; High Altitude

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Establishing normal oxygen saturation and perfusion index values at high altitude

  Postnatal 24-48 hours

Interventions

oxygen saturation and perfusion index screening OTHER

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

Eligibility Criteria

• Age: 24 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborns with ≥34 weeks of gestational age

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Medical Faculty

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Oxygen Saturation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: June 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)