Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN
NCT ID: NCT05842109
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
112 participants
OBSERVATIONAL
2023-10-31
2026-12-31
Brief Summary
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1. Comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as End-tidal carbon monoxide corrected for ambient CO(ETCOc),direct antiglobulin test(DAT), the highest total serum bilirubin level and hemoglobin. To explore the role of ETCOc in the diagnosis of neonatal ABO hemolytic disease.
2. Comparing of the clinical indicators between the neonates with IVIG treatment and the neonates without IVIG treatment in ABO hemolytic disease, such as ETCOc,total serum bilirubin level before IVIG treatment and ETCOc,total serum bilirubin level after IVIG treatment.To explore the clinical value of ETCOc in the treatment of ABO hemolytic disease.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ABO HDN
positive in diagnosis of ABO-HDN
No interventions assigned to this group
non ABO HDN
negative in diagnosis of ABO-HDN
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* birth weight ≥ 2500 grams
* respiratory rate \< 60 breaths per minute
* the neonates admitted to the neonatology department for phototherapy because of hyperbilirubinemia that conforms to the guideline of the experts consensus on the management of neonatal hyperbilirubinemia(2014,in China.)
* ABO group incompatibility between the mother and newborn
* the informed consent are obtained.
Exclusion Criteria
* skin damage or structural deformity around the nasal cavity
* receive intensive care treatment in the neonatal intensive care unit(NICU)
* Severe congenital malformation, chromosomal or genetic abnormality
7 Days
ALL
No
Sponsors
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Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yingying Bao, M.M.
Role: PRINCIPAL_INVESTIGATOR
Women's Hospital School Of Medicine Zhejiang University
Locations
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Women's hospital School of medicine Zhejiang University
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yingying Bao
Role: primary
References
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Watchko JF. ABO hemolytic disease of the newborn: a need for clarity and consistency in diagnosis. J Perinatol. 2023 Feb;43(2):242-247. doi: 10.1038/s41372-022-01556-6. Epub 2022 Nov 8.
De Winter DP, Hulzebos C, Van 't Oever RM, De Haas M, Verweij EJ, Lopriore E. History and current standard of postnatal management in hemolytic disease of the fetus and newborn. Eur J Pediatr. 2023 Feb;182(2):489-500. doi: 10.1007/s00431-022-04724-0. Epub 2022 Dec 5.
Christensen RD, Bahr TM, Pakdeeto S, Supapannachart S, Zhang H. Perinatal Hemolytic Disorders and Identification Using End Tidal Breath Carbon Monoxide. Curr Pediatr Rev. 2023;19(4):376-387. doi: 10.2174/1573396319666221220095522.
Lozar Krivec J, Lozar Manfreda K, Paro-Panjan D. Clinical Factors Influencing Endogenous Carbon Monoxide Production and Carboxyhemoglobin Levels in Neonates. J Pediatr Hematol Oncol. 2022 Jan 1;44(1):e84-e90. doi: 10.1097/MPH.0000000000002143.
Myle AK, Al-Khattabi GH. Hemolytic Disease of the Newborn: A Review of Current Trends and Prospects. Pediatric Health Med Ther. 2021 Oct 7;12:491-498. doi: 10.2147/PHMT.S327032. eCollection 2021.
Jackson ME, Baker JM. Hemolytic Disease of the Fetus and Newborn: Historical and Current State. Clin Lab Med. 2021 Mar;41(1):133-151. doi: 10.1016/j.cll.2020.10.009. Epub 2020 Dec 24.
Karabulut B, Arcagok BC. A Neglected and Promising Predictor of Severe Hyperbilirubinemia Due to Hemolysis: Carboxyhemoglobin. Fetal Pediatr Pathol. 2020 Apr;39(2):124-131. doi: 10.1080/15513815.2019.1641862. Epub 2019 Jul 19.
Tidmarsh GF, Wong RJ, Stevenson DK. End-tidal carbon monoxide and hemolysis. J Perinatol. 2014 Aug;34(8):577-81. doi: 10.1038/jp.2014.66. Epub 2014 Apr 17.
Other Identifiers
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ETCOc in ABO-HDN
Identifier Type: -
Identifier Source: org_study_id
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