Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Other: Internet Plus technology; Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）

Study type: Interventional

Funder types: Other

Identifiers

NCT05365984

PRO2021-1366

Details and patient eligibility

About

In this prospective multi-center randomized clinical trial, a new follow-up strategy for neonatal jaundice after discharge will be evaluated. It is based on current risk factors of neonatal hyperbilirubinemia, added with the rate of bilirubin production (exhaled carbon monoxide measurement) as a new indicator,and incorporated with Internet Plus technology. Traditional methods following the Chinese guideline for neonatal hyperbilirubinemia were applied in the control group. The morbidity of BIND, the number of outpatient follow-up after discharge and the convenience will be compared between the two groups. The accuracy, effectiveness, safety and convenience of the study strategy will be testified.

Full description

The eligible newborns will be randomized into two groups: the study group (innovative strategy) and the controlled group (traditional strategy).

The innovative strategy included the ETCOc measurement in the risk evaluating process and the Internet Plus approach in the follow-up process.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 12 hours to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. gestational age between 35(+0)~41(+6)
2. birth weight ≥ 2500 g
3. ethics approval obtained
4. parental consent obtained

Exclusion criteria

1. severe perinatal asphyxia
2. infectious diseases
3. persistent need for respiratory support
4. major congenital malformation
5. inborn errors of metabolism
6. pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

innavative modeled strategy

Experimental group

Description:

In this arm, the risk evaluation before discharge for hyperbilirubenemia needing further intervention is based on Bhutani nomogram and end tidal carbon monoxide corrected for ambient carbon monoxide. Assessment result includes high risk, median risk, low risk and delayed discharge. Internet Plus technology is applied in follow-up management.

Treatment:

Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）

Other: Internet Plus technology

traditional strategy

No Intervention group

Description:

In this arm, the risk evaluation before discharge for hyperbilirubenemia needing further intervention is based on Bhutani nomogram and the follow-up table advised by the Chinese guideline for neonatal hyperbilirubinemia. Assessment result includes high risk, median risk and low risk. Traditional outpatient is applied in follow-up management.