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Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study

INTRODUCTION: Establishing the reference interval for pulse oxygen saturation (SpO(2)) is essential for sensitively identifying neonatal hypoxaemia due to various causes. However, the reference interval for high altitudes has not yet been established, and existing studies have many limitations. This...

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Autores principales: Wang, Bo, Liu, Chongde, Yao, Yanli, Lu, Zhihui, Yu, Rong, CaiRen, Zhuoma, Wang, Zhixiu, Liu, Runwu, Wu, Yazhen, Yu, Zhangbin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036428/
https://www.ncbi.nlm.nih.gov/pubmed/35459680
http://dx.doi.org/10.1136/bmjopen-2021-060444
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author Wang, Bo
Liu, Chongde
Yao, Yanli
Lu, Zhihui
Yu, Rong
CaiRen, Zhuoma
Wang, Zhixiu
Liu, Runwu
Wu, Yazhen
Yu, Zhangbin
author_facet Wang, Bo
Liu, Chongde
Yao, Yanli
Lu, Zhihui
Yu, Rong
CaiRen, Zhuoma
Wang, Zhixiu
Liu, Runwu
Wu, Yazhen
Yu, Zhangbin
author_sort Wang, Bo
collection PubMed
description INTRODUCTION: Establishing the reference interval for pulse oxygen saturation (SpO(2)) is essential for sensitively identifying neonatal hypoxaemia due to various causes. However, the reference interval for high altitudes has not yet been established, and existing studies have many limitations. This study will aim to establish the reference interval for various high altitudes and determine whether preductal and postductal measurements at the same altitude vary. METHODS AND ANALYSIS: This is a multicentre, open, cross-sectional study, which will begin in February 2022. Approximately 2000 healthy full-term singleton neonates will be recruited from six hospitals (altitude ≥2000 m) in Qinghai Province, China. The participating hospitals will use a uniform pulse oximeter type. The measurements will be performed between 24 hours after birth and discharge. During the measurement, the neonate will be awake and quiet. Preductal and postductal measurements will be performed. The measurement time, site and results will be recorded and input, along with the collected basic information, into the perinatal cloud database. We will carry out strict quality control for basic information collection, measurement and data filing. We will perform descriptive statistics on the distribution range of the collected data, determine the lower limit value of the reference interval for each hospital and the corresponding altitude, perform curve fitting for the lower limit value, use the altitude as a covariate for the function corresponding to the fitted curve, establish the prediction equation and ultimately determine the reference intervals of each high altitude location. ETHICS AND DISSEMINATION: Our protocol has been approved by the Medical Ethics Committee of all participating hospitals. We will publish our study results in academic conferences and peer-reviewed public journals. TRIAL REGISTRATION NUMBER: NCT05115721.
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spelling pubmed-90364282022-05-06 Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study Wang, Bo Liu, Chongde Yao, Yanli Lu, Zhihui Yu, Rong CaiRen, Zhuoma Wang, Zhixiu Liu, Runwu Wu, Yazhen Yu, Zhangbin BMJ Open Paediatrics INTRODUCTION: Establishing the reference interval for pulse oxygen saturation (SpO(2)) is essential for sensitively identifying neonatal hypoxaemia due to various causes. However, the reference interval for high altitudes has not yet been established, and existing studies have many limitations. This study will aim to establish the reference interval for various high altitudes and determine whether preductal and postductal measurements at the same altitude vary. METHODS AND ANALYSIS: This is a multicentre, open, cross-sectional study, which will begin in February 2022. Approximately 2000 healthy full-term singleton neonates will be recruited from six hospitals (altitude ≥2000 m) in Qinghai Province, China. The participating hospitals will use a uniform pulse oximeter type. The measurements will be performed between 24 hours after birth and discharge. During the measurement, the neonate will be awake and quiet. Preductal and postductal measurements will be performed. The measurement time, site and results will be recorded and input, along with the collected basic information, into the perinatal cloud database. We will carry out strict quality control for basic information collection, measurement and data filing. We will perform descriptive statistics on the distribution range of the collected data, determine the lower limit value of the reference interval for each hospital and the corresponding altitude, perform curve fitting for the lower limit value, use the altitude as a covariate for the function corresponding to the fitted curve, establish the prediction equation and ultimately determine the reference intervals of each high altitude location. ETHICS AND DISSEMINATION: Our protocol has been approved by the Medical Ethics Committee of all participating hospitals. We will publish our study results in academic conferences and peer-reviewed public journals. TRIAL REGISTRATION NUMBER: NCT05115721. BMJ Publishing Group 2022-04-22 /pmc/articles/PMC9036428/ /pubmed/35459680 http://dx.doi.org/10.1136/bmjopen-2021-060444 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Paediatrics
Wang, Bo
Liu, Chongde
Yao, Yanli
Lu, Zhihui
Yu, Rong
CaiRen, Zhuoma
Wang, Zhixiu
Liu, Runwu
Wu, Yazhen
Yu, Zhangbin
Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title_full Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title_fullStr Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title_full_unstemmed Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title_short Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
title_sort establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
topic Paediatrics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036428/
https://www.ncbi.nlm.nih.gov/pubmed/35459680
http://dx.doi.org/10.1136/bmjopen-2021-060444
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