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Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05468515
Enrollment
956
Registered
2022-07-21
Start date
2022-03-15
Completion date
2023-02-27
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Altitude Hypoxia, Neonatal Disease

Keywords

pulse oxygen saturation, neonate, altitude, umbilical arterial blood gas

Brief 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.

Interventions

DIAGNOSTIC_TESTpulse oxygen saturation

preductal oxygen saturation

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Hours to 2 Hours
Healthy volunteers
Yes

Inclusion criteria

* Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by: 1. normal vital signs (heart rate ranging from 110 to 180 beats/minute, respiratory rate ranging from 30 to 60 breaths/minute, temperature ranging from 36.5°C to 37.5°C), 2. absence of signs of illness such as respiratory distress. 3. the mothers resided in the study area.

Exclusion criteria

* outborn, require resuscitative interventions at birth beyond blow-by oxygen, * require admission for any reason other than observation or had a major congenital anomaly.

Design outcomes

Primary

MeasureTime frameDescription
pulse oxygen saturationduring first 2 hours after birthpreductal pulse oxygen saturation during first two hours after birth

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026