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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 7
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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 population

positive in diagnosis of ABO-HDN

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

112 Participants
are grouped into 2 trial groups
Group A: ABO HDN
Group B: non ABO HDN

Trial outcomes

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

Other outcomes

Sponsors and contacts

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