An interventional study of end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc） and Internet Plus technology in Hyperbilirubinemia, Neonatal, sponsored by Women's Hospital School Of Medicine Zhejiang University. Status unknown. Open to participants aged 12 Hours to 7 Days. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Prevention
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.
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.
105 studies on the registry are indexed under Jaundice, Neonatal; 27 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 134 across 74 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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） · Other: Internet Plus technology
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.
The measurement of end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）is conducted in the process of risk evaluation.
The Internet Plus technology is applied in the process of follow-up management.
the incidence of acute bilirubin encephalitis
the number of infants with acute bilirubin encephalitis in each group
Time frame: within 2 week after birth
the bilirubin level of readministration for hyperbilirubinemia
the average bilirubin level of infants, who are readmitted for hyperbilirubinemia
Time frame: within 1 months
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
Time frame: 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
Time frame: within 1 month
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Women's Hospital School Of Medicine Zhejiang University