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

Not Applicable

Not yet recruiting

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Diagnostic Test: end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）; Other: Internet Plus technology

• Registration Number: NCT05365984
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study Start: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
innavative modeled strategy	Internet Plus technology	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.
innavative modeled strategy	end tidal carbon monoxide corrected for ambient carbon monoxide （ETCOc）	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.

Primary Outcome Measures

Name	Time	Method
the bilirubin level of readministration for hyperbilirubinemia	within 1 months	the average bilirubin level of infants, who are readmitted for hyperbilirubinemia
the incidence of acute bilirubin encephalitis	within 2 week after birth	the number of infants with acute bilirubin encephalitis in each group

Secondary Outcome Measures

Name	Time	Method
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
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