Clinical trial NCT05468515: Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Disease
Altitude Hypoxia
Keywords: pulse oxygen saturation
neonate
altitude
umbilical arterial blood gas
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 956
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included infants with a gestational age between 35 to 42 weeks who were born alive and appearing well

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.


Eligibility criteria: 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.

Primary outcomes:
measure: pulse oxygen saturation
timeFrame: during first 2 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
Study officials:
References:
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