NCT05365984

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: All
• Age: 12 Hours – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	end 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.
OTHER	Internet Plus technology	The Internet Plus technology is applied in the process of follow-up management.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-05-09
• Last updated: 2022-05-09