High Altitude Clinical Trial
Official title:
Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude
Verified date | February 2020 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ataturk University Medical Faculty | Erzurum |
Lead Sponsor | Collaborator |
---|---|
Ataturk University |
Turkey,
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 |
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