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OpenTrials
Completed

NCT Number: NCT05468515

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

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.

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Key information

Age range

0 hour–2 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, 201102, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:
  • 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),
  • absence of signs of illness such as respiratory distress.
  • 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.

Treatment and study plan

pulse oxygen saturation

Diagnostic Test

preductal oxygen saturation

Other names: umbilical blood gas analysis

Primary outcomes

  1. pulse oxygen saturation

    Time frame: during first 2 hours after birth

    preductal pulse oxygen saturation during first two hours after birth

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2022
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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