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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High altitude group | altitude level range from 2500 to 4500 meters |
| |
| mild altitude group | altitude level range from 500 to 2500 meters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulse oxygen saturation | Diagnostic Test | preductal oxygen saturation |
|
| Measure | Description | Time Frame |
|---|---|---|
| pulse oxygen saturation | preductal pulse oxygen saturation during first two hours after birth | during first 2 hours after birth |
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Inclusion Criteria:
Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:
Exclusion Criteria:
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The study included infants with a gestational age between 35 to 42 weeks who were born alive and appearing well
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Shanghai | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28939700 | Background | 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. | |
| 32504134 | 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. |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 16156890 | 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. |
| 20049329 | 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. |
| 12049291 | 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. |
| 15855304 | 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. |
| 34446476 | 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. |
| 17493520 | 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. |