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Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude

A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05115721
Enrollment
10000
Registered
2021-11-10
Start date
2022-02-01
Completion date
2023-02-10
Last updated
2022-03-03

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

Conditions

High Altitude

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.

Interventions

OTHERno intervention

It's only observational study. No interventions.

Sponsors

Affiliated Hospital of Qinghai University
CollaboratorOTHER
Qinghai Red Cross Hospital
CollaboratorOTHER
Qinghai Women and Children's Hospital
CollaboratorUNKNOWN
Geermu People's Hospital
CollaboratorUNKNOWN
Yushu Prefecture People's Hospital
CollaboratorUNKNOWN
Guoluo Tibetan Autonomous Prefecture People's Hospital
CollaboratorUNKNOWN
Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
24 Hours to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulse oxygen saturation of healthy neonates at high altitude.24 hours after birthPulse oxygen saturation of the right hand and any foot of healthy neonates born at high altitude will be measured 24 hours after birth. According to the normality of the results, the distribution range will be described by mean ± standard deviation or range interquartile. Altitude level: ≥ 2000m.

Countries

China

Contacts

Primary ContactZhangbin Yu, PHD
yuzhangbin@126.com+86-025-52226567

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026