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

NCT05365984 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2022-05-09

No results posted yet for this study

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.

Conditions

  • Hyperbilirubinemia, Neonatal

Interventions

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.

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • Jiaxing University Affiliated Women and Children Hospital

    collaborator UNKNOWN

  • Ningbo Women & Children's Hospital

    collaborator OTHER

  • Shaoxing Women's and Children's Hospital

    collaborator UNKNOWN

  • Jinhua Central Hospital

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • Jiajun Zhu · Women's Hospital School Of Medicine Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2024-06-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365984 on ClinicalTrials.gov