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

• Conditions: High Altitude
• Interventions: Other: no intervention

• Registration Number: NCT05115721
• Lead Sponsor: Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2021-10-30
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Status Verified: 2022-02
• Study Start: 2022-02-01
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-03
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-ductal SpO2	no intervention	-
Post-ductal SpO2	no intervention	-

Primary Outcome Measures

Name	Time	Method
Pulse oxygen saturation of healthy neonates at high altitude.	24 hours after birth	Pulse 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.

Trial Locations

Locations (1)

Qinghai Women and Children's Hospital; 🇨🇳 Xining, Qinghai, China