Clinical trial NCT05365984: Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications
Official title: Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperbilirubinemia, Neonatal
Keywords: End tidal carbon monoxide
Internet Plus
jaundice follow-up management model
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Children's Hospital of Zhejiang University School of Medicine
name: Jiaxing University Affiliated Women and Children Hospital
name: Ningbo Women & Children's Hospital
name: Shaoxing Women's and Children's Hospital
name: Jinhua Central Hospital
First posted: 2022-05-09
Enrollment: 2500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of acute bilirubin encephalitis
timeFrame: within 2 week after birth
measure: the bilirubin level of readministration for hyperbilirubinemia
timeFrame: within 1 months
Secondary outcomes:
measure: the cost for the issue of jaundice follow-up
timeFrame: within 1 month
measure: the time for the issue of jaundice follow-up
timeFrame: within 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Jiajun Zhu
role: PRINCIPAL_INVESTIGATOR
References:
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