Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas

Neonatal Disease Clinical Trial

Official title:

Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas: a Multicenter Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468515
• Other study ID #: 2021-03-146-K01
• Status: Completed
• Start date: March 15, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: June 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal transition may be different at high altitudes. Umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. But there are only limited studies about the SpO2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. The primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. The secondary outcomes is to establish the pH and lactate cutoff value of umbilical arterial blood gas at different altitude level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: February 27, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Hours to 2 Hours

Eligibility

Inclusion Criteria:

• Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:

1. normal vital signs (heart rate ranging from 110 to 180 beats/minute, respiratory rate ranging from 30 to 60 breaths/minute, temperature ranging from 36.5°C to 37.5°C),

2. absence of signs of illness such as respiratory distress.

3. the mothers resided in the study area.

Exclusion Criteria:

• outborn, require resuscitative interventions at birth beyond blow-by oxygen,

• require admission for any reason other than observation or had a major congenital anomaly.

Related Conditions & MeSH terms

• Altitude Hypoxia
• Altitude Sickness
• Hypoxia
• Infant, Newborn, Diseases
• Neonatal Disease

Intervention

Diagnostic Test:
• pulse oxygen saturation
preductal oxygen saturation

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (8)

Bakr AF, Habib HS. Normal values of pulse oximetry in newborns at high altitude. J Trop Pediatr. 2005 Jun;51(3):170-3. doi: 10.1093/tropej/fmi026. Epub 2005 Apr 26. — View Citation

Bellera CA, Hanley JA. A method is presented to plan the required sample size when estimating regression-based reference limits. J Clin Epidemiol. 2007 Jun;60(6):610-5. doi: 10.1016/j.jclinepi.2006.09.004. Epub 2007 Jan 16. — View Citation

Gonzales GF, Salirrosas A. Arterial oxygen saturation in healthy newborns delivered at term in Cerro de Pasco (4340 m) and Lima (150 m). Reprod Biol Endocrinol. 2005 Sep 12;3:46. doi: 10.1186/1477-7827-3-46. — View Citation

Hu XJ, Ma XJ, Zhao QM, Yan WL, Ge XL, Jia B, Liu F, Wu L, Ye M, Liang XC, Zhang J, Gao Y, Zhai XW, Huang GY. Pulse Oximetry and Auscultation for Congenital Heart Disease Detection. Pediatrics. 2017 Oct;140(4):e20171154. doi: 10.1542/peds.2017-1154. — View Citation

Ogik V, Muyingo M, Musooko M, Nankunda J. Umbilical artery lactate levels and associated maternal and newborn characteristics at Mulago National Referral Hospital: a cross-sectional observational study. BMJ Open. 2021 Aug 26;11(8):e043827. doi: 10.1136/bmjopen-2020-043827. — View Citation

Tekgunduz KS, Bilen M, Kara M, Laloglu F, Ceviz N. Oxygen saturation and perfusion index screening in neonates at high altitudes: can PDA be predicted? Eur J Pediatr. 2021 Jan;180(1):31-38. doi: 10.1007/s00431-020-03698-1. Epub 2020 Jun 5. — View Citation

Toth B, Becker A, Seelbach-Gobel B. Oxygen saturation in healthy newborn infants immediately after birth measured by pulse oximetry. Arch Gynecol Obstet. 2002 Apr;266(2):105-7. doi: 10.1007/s00404-001-0272-5. — View Citation

Zamudio S, Torricos T, Fik E, Oyala M, Echalar L, Pullockaran J, Tutino E, Martin B, Belliappa S, Balanza E, Illsley NP. Hypoglycemia and the origin of hypoxia-induced reduction in human fetal growth. PLoS One. 2010 Jan 1;5(1):e8551. doi: 10.1371/journal.pone.0008551. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse oxygen saturation	preductal pulse oxygen saturation during first two hours after birth	during first 2 hours after birth