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

High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115721
• Other study ID #: NMU-FY2021-59
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2022
• Source: Nanjing Medical University
• Contact: Zhangbin Yu, PHD
• Phone: +86-025-52226567
• Email: yuzhangbin[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: February 10, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude

Intervention

Other:
• no intervention
It's only observational study. No interventions.

Locations

Country	Name	City	State
China	Qinghai Women and Children's Hospital	Xining	Qinghai

Sponsors (7)

Lead Sponsor	Collaborator
Nanjing Medical University	Affiliated Hospital of Qinghai University, Geermu People's Hospital, Guoluo Tibetan Autonomous Prefecture People's Hospital, Qinghai Red Cross Hospital, Qinghai Women and Children's Hospital, Yushu Prefecture People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse oxygen saturation of healthy neonates at high altitude.	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.	24 hours after birth