Hyperbilirubinemia, Neonatal
Conditions
Keywords
End tidal carbon monoxide, Internet Plus, jaundice follow-up management model
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.
Interventions
DIAGNOSTIC_TESTend tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）
The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）is conducted in the process of risk evaluation.
OTHERInternet Plus technology
The Internet Plus technology is applied in the process of follow-up management.
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Jiaxing University Affiliated Women and Children Hospital
Ningbo Women & Children's Hospital
Shaoxing Women's and Children's Hospital
Jinhua Central Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Hours to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of acute bilirubin encephalitis | within 2 week after birth | the number of infants with acute bilirubin encephalitis in each group |
| the bilirubin level of readministration for hyperbilirubinemia | within 1 months | the average bilirubin level of infants, who are readmitted for hyperbilirubinemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the cost for the issue of jaundice follow-up | within 1 month | compare the fee for intelligent follow-up with the fee for clinical visiting according to present jaundice follow-up suggestion |
| the time for the issue of jaundice follow-up | within 1 month | 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 |
Contacts
Primary ContactJiajun Zhu, doctor
Outcome results
None listed