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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn

Conditions
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ABO Hemolytic Disease of Newborn

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABO HDN<br>positive in diagnosis of ABO-HDN | |
| non ABO HDN<br>negative in diagnosis of ABO-HDN | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | through study completion, planned to be 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End tidal carbon monoxide, hyperbilirubinemia, ABO Hemolytic Disease of Newborn