Clinical trial NCT05115721: Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
Official title: A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Altitude
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Qinghai University
name: Qinghai Red Cross Hospital
name: Qinghai Women and Children's Hospital
name: Geermu People's Hospital
name: Yushu Prefecture People's Hospital
name: Guoluo Tibetan Autonomous Prefecture People's Hospital
First posted: 2021-11-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutively delivered and eligible neonates at the various medical centers at different altitudes during the study will be included. The study period is from November 20, 2021 to November 20, 2022.

Brief summary: The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.

Detailed description: Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.

Eligibility criteria: Inclusion Criteria:

* Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.).

Exclusion Criteria:

* 1. Low birth weight (\< 2500 g). 2. Need for oxygen. 3.1 or 5 minute Apgar score \< 7. 4. Referred to the neonatal intensive care unit or neonatology department for various reasons. 5. Neonates discharged within 24 hours of birth. 6. Neonates diagnosed with congenital diseases in utero. 7. Refusal of consent.

Primary outcomes:
measure: Pulse oxygen saturation of healthy neonates at high altitude.
timeFrame: 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai Women and Children's Hospital
state: Qinghai
Study officials:
affiliation: Jinan University
name: Zhangbin Yu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang B, Liu C, Yao Y, Lu Z, Yu R, CaiRen Z, Wang Z, Liu R, Wu Y, Yu Z. Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study. BMJ Open. 2022 Apr 22;12(4):e060444. doi: 10.1136/bmjopen-2021-060444.