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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-02-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High Altitude

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pre-ductal SpO2

no intervention

Intervention Type OTHER

It's only observational study. No interventions.

Post-ductal SpO2

no intervention

Intervention Type OTHER

It's only observational study. No interventions.

Interventions

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no intervention

It's only observational study. No interventions.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

24 Hours

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes