Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04290481
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2020-02-27
Brief Title:
Oxygen Saturation and Perfusion Index ın Neonates at High Altitude
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Congenital heart diseases are among the most common congenital anomalies and occur with an incidence of approximately 8ınd12 1000 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 070 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
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 070 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None