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

NCT05115721 | Unknown DMC

• 1 other identifier: NMU-FY2021-59
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

High Altitude

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pre-ductal SpO2

Other: no intervention

Post-ductal SpO2

Other: no intervention

Interventions

no intervention OTHER

It's only observational study. No interventions.

Post-ductal SpO2; Pre-ductal SpO2

Eligibility Criteria

• Age: 24 Hours - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• Affiliated Hospital of Qinghai University: collaborator
• Qinghai Red Cross Hospital: collaborator
• Qinghai Women and Children's Hospital: collaborator
• Geermu People's Hospital: collaborator
• Yushu Prefecture People's Hospital: collaborator
• Guoluo Tibetan Autonomous Prefecture People's Hospital: collaborator

Study Sites (1)

Qinghai Women and Children's Hospital

Xining, Qinghai, 810000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35459680 DERIVED

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Zhangbin Yu, PHD

  Jinan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhangbin Yu, PHD

CONTACT

+86-025-52226567; yuzhangbin@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor，Shenzhen People's Hospital

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 10, 2021
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 10, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

CN (1)