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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）
* Other: Internet Plus technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Hours
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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: innavative modeled strategy<br>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. | Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）<br>* The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）is conducted in the process of risk evaluation.<br>Other: Internet Plus technology<br>* The Internet Plus technology is applied in the process of follow-up management.<br>|
| No Intervention: traditional strategy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of acute bilirubin encephalitis | the number of infants with acute bilirubin encephalitis in each group | within 2 week after birth | 
| the bilirubin level of readministration for hyperbilirubinemia | the average bilirubin level of infants, who are readmitted for hyperbilirubinemia | within 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cost for the issue of jaundice follow-up | compare the fee for intelligent follow-up with the fee for clinical visiting according to present jaundice follow-up suggestion | within 1 month | 
| the time for the issue of jaundice follow-up | compare the time for intelligent follow-up，including the time for TSB measurement and internet commuication，with the time for clinical visiting according to present jaundice follow-up suggestion | within 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End tidal carbon monoxide, Internet Plus, jaundice follow-up management model