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

NCT05468515 | Completed

• 1 other identifier: 2021-03-146-K01
• Study Type: observational
• Target: 956
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Disease; Altitude Hypoxia

Keywords

pulse oxygen saturation; neonate; altitude; umbilical arterial blood gas

Outcome Measures

Primary Outcomes (1)

• pulse oxygen saturation

  preductal pulse oxygen saturation during first two hours after birth

  during first 2 hours after birth

Study Arms (2)

High altitude group

altitude level range from 2500 to 4500 meters

Diagnostic Test: pulse oxygen saturation

mild altitude group

altitude level range from 500 to 2500 meters

Diagnostic Test: pulse oxygen saturation

Interventions

pulse oxygen saturation DIAGNOSTIC_TEST

preductal oxygen saturation

Also known as: umbilical blood gas analysis

High altitude group; mild altitude group

Eligibility Criteria

• Age: 0 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study included infants with a gestational age between 35 to 42 weeks who were born alive and appearing well

You may qualify if:

• Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:
• 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),
• absence of signs of illness such as respiratory distress.
• the mothers resided in the study area.

You may not qualify if:

• outborn, require resuscitative interventions at birth beyond blow-by oxygen,
• require admission for any reason other than observation or had a major congenital anomaly.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children Hospital of Fudan University

Shanghai, 201102, China

Location

Related Publications (8)

• 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.

  PMID: 28939700 BACKGROUND

• 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.

  PMID: 32504134 BACKGROUND

• 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.

  PMID: 16156890 BACKGROUND

• 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.

  PMID: 20049329 BACKGROUND

• 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.

  PMID: 12049291 BACKGROUND

• 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.

  PMID: 15855304 BACKGROUND

• 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.

  PMID: 34446476 BACKGROUND

• 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.

  PMID: 17493520 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases; Altitude Sickness

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 21, 2022
• Study Start: March 15, 2022
• Primary Completion: October 10, 2022
• Study Completion: February 27, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)