CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 956 enrolled
Drug / intervention
pulse oxygen saturationother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05468515
NCT05468515N/ACompleted

Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas: a Multicenter Prospective Study

Children's Hospital of Fudan University·observational·Posted Jul 21, 2022·Updated Jun 5, 2023

In Brief

An observational study evaluating pulse oxygen saturation for Neonatal Disease and Altitude Hypoxia. Completed, enrolled 956 participants across 1 site.

Detailed Summary

Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal transition may be different at high altitudes. Umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. But there are only limited studies about the SpO2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. The primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. The secondary outcomes is to establish the pH and lactate cutoff value of umbilical arterial blood gas at different altitude level.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 21, 2022
Enrollment StartMar 15, 2022
Primary CompletionOct 10, 2022
Study CompletionFeb 27, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.9 years ago

Interventions

pulse oxygen saturationother

preductal oxygen saturation