Clinical trial NCT05842109: Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN
Official title: Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ABO Hemolytic Disease of Newborn
Keywords: End tidal carbon monoxide
hyperbilirubinemia
ABO Hemolytic Disease of Newborn
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 112
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: positive in diagnosis of ABO-HDN

Brief summary: A prospective observational cohort study was designed.

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.

Detailed description: A prospective observational cohort study was designed. The participants included in the study are the neonates with hyperbilirubinemia in ABO incompatibility.Because the serological results are not known at the time of enrollment, all the neonates should be suspected hemolysis. According to the serological results,the neonates are divided into two groups, hemolytic group and non-hemolytic group. All the relevant clinical indicators need to be recorded and each neonates needs follow-up.

Eligibility criteria: Inclusion Criteria:

* gestational age between 35+0 and 41+6 weeks
* 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:

* persistent dyspnea or need for respiratory support
* 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

Primary outcomes:
measure: concentration of ETCOc (end tidal carbon monoxide)
timeFrame: through study completion, planned to be 1.5 year
Secondary outcomes:
measure: concentration of bilirubin
timeFrame: through study completion, planned to be 1.5 year
measure: result of DAT
timeFrame: through study completion, planned to be 1.5 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's hospital School of medicine Zhejiang University
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Yingying Bao, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.