Clinical Value of ETCOc in the Diagnosis and Treatment of... | NCT05842109

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

NCT05842109

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Status

Recruiting

Last Update Posted

Feb 5, 2025Actual

Enrollment

112Estimated

Phase

Not provided

Conditions

ABO Hemolytic Disease of Newborn

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2023Actual

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 10, 2023

First Submission Date that Met QC Criteria

May 2, 2023

First Posted Date

May 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABO HDN		positive in diagnosis of ABO-HDN
non ABO HDN		negative in diagnosis of ABO-HDN

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
concentration of ETCOc (end tidal carbon monoxide)	ETCOc in ppm	through study completion, planned to be 1.5 year

Secondary Outcomes

Measure	Description	Time Frame
concentration of bilirubin	bilirubin in mg/dl	through study completion, planned to be 1.5 year
result of DAT	DAT result of positive or negtive

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

positive in diagnosis of ABO-HDN

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yingying Bao, M.M.	Contact	13777834165		yingyingbao@zju.edu.cn
Chuncai Xu, M.M.	Contact	15257168032		chuncaixu@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Yingying Bao, M.M.	Women's Hospital School Of Medicine Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's hospital School of medicine Zhejiang University	Recruiting	Hangzhou			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36344813	Background	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.
36469119	Background	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms