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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

Tracking Information
First Submitted Date February 27, 2020
First Posted Date March 2, 2020
Last Update Posted Date March 2, 2020
Actual Study Start Date June 1, 2018
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 27, 2020)
Establishing normal oxygen saturation and perfusion index values at high altitude [ Time Frame: Postnatal 24-48 hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oxygen Saturation and Perfusion Index ın Neonates at High Altitude
Official Title Oxygen Saturation and Perfusion Index Screening ın Neonates at High Altitude
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Newborns with ≥34 weeks of gestational age
Condition
  • Critical Congenital Heart Disease
  • High Altitude
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 27, 2020)
501
Original Actual Enrollment Same as current
Actual Study Completion Date February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 48 Hours   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04290481
Other Study ID Numbers B.30.2.ATA.0.01.00/32
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kadir Şerafettin Tekgündüz, Ataturk University
Study Sponsor Ataturk University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ataturk University
Verification Date February 2020