Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842109
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-10
Brief Title:
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN
Sponsor:
Womens Hospital School Of Medicine Zhejiang University
Organization:
Womens Hospital School Of Medicine Zhejiang University
Study Overview
Official Title:
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective observational cohort study was designed
1 Comparing of the clinical indicators between the hemolytic group and the non-hemolytic groupsuch as End-tidal carbon monoxide corrected for ambient COETCOcdirect antiglobulin testDAT 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 ETCOctotal serum bilirubin level before IVIG treatment and ETCOctotal serum bilirubin level after IVIG treatmentTo explore the clinical value of ETCOc in the treatment of ABO hemolytic disease
1 Comparing of the clinical indicators between the hemolytic group and the non-hemolytic groupsuch as End-tidal carbon monoxide corrected for ambient COETCOcdirect antiglobulin testDAT 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 ETCOctotal serum bilirubin level before IVIG treatment and ETCOctotal serum bilirubin level after IVIG treatmentTo 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 incompatibilityBecause the serological results are not known at the time of enrollment all the neonates should be suspected hemolysis According to the serological resultsthe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None