Hyperbilirubinemia, Neonatal Clinical Trial
Official title:
Study on the Intelligent Follow-up Management Model of Neonatal Jaundice After Discharge Based on Early Multi-dimensional Indicators and Internet Communications
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.
Status | Not yet recruiting |
Enrollment | 2500 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Days |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Women's Hospital School Of Medicine Zhejiang University | Jiaxing University Affiliated Women and Children Hospital, Jinhua Central Hospital, Ningbo Women and Children's Hospital, Shaoxing Women's and Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine |
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Cortey A, Renesme L, Raignoux J, Bedu A, Casper C, Tourneux P, Truffert P. [Management of jaundice in the newborn=35 GW: From screening to follow-up after discharge. Guidelines for clinical practice]. Arch Pediatr. 2017 Feb;24(2):192-203. doi: 10.1016/j.arcped.2016.11.011. Epub 2017 Jan 14. French. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the incidence of acute bilirubin encephalitis | the number of infants with acute bilirubin encephalitis in each group | within 2 week after birth | |
Primary | the bilirubin level of readministration for hyperbilirubinemia | the average bilirubin level of infants, who are readmitted for hyperbilirubinemia | within 1 months | |
Secondary | 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 | |
Secondary | 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 |
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