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Oxygen Saturation and Perfusion Index ın Neonates at High Altitude

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ClinicalTrials.gov Identifier: NCT04290481
Recruitment Status : Completed
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Kadir Şerafettin Tekgündüz, Ataturk University

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.


Condition or disease Intervention/treatment
Critical Congenital Heart Disease High Altitude Other: oxygen saturation and perfusion index screening

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Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Establishing threshold values for critical congenital heart disease screening at high altitude [ Time Frame: Postnatal 24-48 hours ]
    We aim to explore whether oxygen saturation and perfusion index threshold values are different compared sea level or not.


Secondary Outcome Measures :
  1. Establishing normal oxygen saturation and perfusion index values at high altitude [ Time Frame: Postnatal 24-48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Newborns with ≥34 weeks of gestational age
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290481


Locations
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Turkey
Ataturk University Medical Faculty
Erzurum, Turkey, 25100
Sponsors and Collaborators
Ataturk University
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Responsible Party: Kadir Şerafettin Tekgündüz, Associate Prof, Ataturk University
ClinicalTrials.gov Identifier: NCT04290481    
Other Study ID Numbers: B.30.2.ATA.0.01.00/32
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Altitude Sickness
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases