ABO Hemolytic Disease of NewbornNCT05842109
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN
An observational study of ABO Hemolytic Disease of Newborn, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- ABO Hemolytic Disease of Newborn
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: positive in diagnosis of ABO-HDN
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's hospital School of medicine Zhejiang University
Hangzhou
Yingying Bao
About this study
Official title: Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
A prospective observational cohort study was designed.
- 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.
- 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.
- Conditions
- ABO Hemolytic Disease of Newborn
- Keywords
- End tidal carbon monoxide, hyperbilirubinemia, ABO Hemolytic Disease of Newborn
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABO HDN | positive in diagnosis of ABO-HDN | |
| non ABO HDN | negative in diagnosis of ABO-HDN |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of ETCOc (end tidal carbon monoxide)
ETCOc in ppm
Measured: through study completion, planned to be 1.5 year
Secondary outcomes (2)
concentration of bilirubin
bilirubin in mg/dl
Measured: through study completion, planned to be 1.5 year
result of DAT
DAT result of positive or negtive
Measured: through study completion, planned to be 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start31 Oct 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ABO Hemolytic Disease of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingying Bao, M.M., Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842109
- Sponsor's protocol ID
- ETCOc in ABO-HDN
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36344813De 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 36469119Christensen 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 36545740Lozar 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 33735151Myle 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 34675752Jackson 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 33494881Karabulut 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 31322449Tidmarsh 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
- ClinicalTrials.gov ID
- NCT05842109
- Acronym / sponsor ID
- ETCOc in ABO-HDN
- Conditions
- ABO Hemolytic Disease of Newborn
- Keywords
- End tidal carbon monoxide, hyperbilirubinemia, ABO Hemolytic Disease of Newborn
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective observational cohort study was designed.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABO HDN | – | –positive in diagnosis of ABO-HDN |
| non ABO HDN | – | –negative in diagnosis of ABO-HDN |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- positive in diagnosis of ABO-HDN
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concentration of ETCOc (end tidal carbon monoxide)
Time frame: through study completion, planned to be 1.5 year
ETCOc in ppm
2 secondary outcomes
concentration of bilirubin
Time frame: through study completion, planned to be 1.5 year
result of DAT
Time frame: through study completion, planned to be 1.5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 36344813Watchko 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.
- Background: PubMed 36469119De 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.
- Background: PubMed 36545740Christensen 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.
- Background: PubMed 33735151Lozar 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.
- Background: PubMed 34675752Myle 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.
- Background: PubMed 33494881Jackson 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.
- Background: PubMed 31322449Karabulut 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.
- Background: PubMed 24743136Tidmarsh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingying Bao, M.M. principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ABO Hemolytic Disease of Newborn, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingying Bao, M.M. (13777834165, yingyingbao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of ETCOc (end tidal carbon monoxide) (time frame: through study completion, planned to be 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842109, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.