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RecruitingNCT05842109Updated Feb 5, 2025

Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN

An observational study in ABO Hemolytic Disease of Newborn, sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
112
Ages
Up to 7 Days
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • ABO Hemolytic Disease of Newborn

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Keywords

  • End tidal carbon monoxide
  • hyperbilirubinemia
  • ABO Hemolytic Disease of Newborn
03

In context

Hyperbilirubinemia

81 studies on the registry are indexed under Hyperbilirubinemia; 11 are open to participants now.

This study's planned enrollment of 112 is below the median of 450 across 25 observational studies indexed under Hyperbilirubinemia.

Browse Hyperbilirubinemia studies →

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

positive in diagnosis of ABO-HDN

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 are obtained.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
112 participants (estimated)
Patient registry
No

Groups and cohorts

  • ABO HDN

    positive in diagnosis of ABO-HDN

  • non ABO HDN

    negative in diagnosis of ABO-HDN

06

What researchers measure

Primary outcomes

  1. concentration of ETCOc (end tidal carbon monoxide)

    ETCOc in ppm

    Time frame: through study completion, planned to be 1.5 year

Secondary outcomes

  1. concentration of bilirubin

    bilirubin in mg/dl

    Time frame: through study completion, planned to be 1.5 year

  2. result of DAT

    DAT result of positive or negtive

    Time frame: through study completion, planned to be 1.5 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 36344813 ↗
  • 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. PubMed 36469119 ↗
  • 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. PubMed 36545740 ↗
  • 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. PubMed 33735151 ↗
  • 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. PubMed 34675752 ↗
  • 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. PubMed 33494881 ↗
  • 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. PubMed 31322449 ↗
  • 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. PubMed 24743136 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05842109
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Sponsor
First posted
May 3, 2023
Start date
Oct 31, 2023
Primary completion
Oct 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 5, 2025

Study contacts

Yingying Bao, M.M.
Contact
yingyingbao@zju.edu.cn
13777834165
Chuncai Xu, M.M.
Contact
chuncaixu@zju.edu.cn
15257168032
Yingying Bao, M.M.
principal investigator · Women's Hospital School Of Medicine Zhejiang University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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