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

Completed

• Conditions: Neonatal Disease; Altitude Hypoxia
• Interventions: Diagnostic Test: pulse oxygen saturation

• Registration Number: NCT05468515
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-21
• Primary Completion: 2022-10-10
• Study Completion: 2023-02-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 956

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High altitude group	pulse oxygen saturation	altitude level range from 2500 to 4500 meters
mild altitude group	pulse oxygen saturation	altitude level range from 500 to 2500 meters

Primary Outcome Measures

Name	Time	Method
pulse oxygen saturation	during first 2 hours after birth	preductal pulse oxygen saturation during first two hours after birth

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, China