Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperbilirubinemia, Neonatal
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Enrollment
- 2500
- Primary Endpoint
- the bilirubin level of readministration for hyperbilirubinemia
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •gestational age between 35(+0)\~41(+6)
- •birth weight ≥ 2500 g
- •ethics approval obtained
- •parental consent obtained
Exclusion Criteria
- •severe perinatal asphyxia
- •infectious diseases
- •persistent need for respiratory support
- •major congenital malformation
- •inborn errors of metabolism
- •pathological neonatal hyperbilirubinemia due to the defects of red blood cell membrane and erythrocyte enzyme
Outcomes
Primary Outcomes
the bilirubin level of readministration for hyperbilirubinemia
Time Frame: within 1 months
the average bilirubin level of infants, who are readmitted for hyperbilirubinemia
the incidence of acute bilirubin encephalitis
Time Frame: within 2 week after birth
the number of infants with acute bilirubin encephalitis in each group
Secondary Outcomes
- the time for the issue of jaundice follow-up(within 1 month)
- the cost for the issue of jaundice follow-up(within 1 month)