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

May 3, 2022 updated by: Women's Hospital School Of Medicine Zhejiang University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: innavative modeled strategy
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）
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.
No Intervention: traditional strategy
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cost for the issue of jaundice follow-up
Time Frame: within 1 month
compare the fee for intelligent follow-up with the fee for clinical visiting according to present jaundice follow-up suggestion
within 1 month
the time for the issue of jaundice follow-up
Time Frame: 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
within 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborators

Jinhua Central Hospital
The Children's Hospital of Zhejiang University School of Medicine
Ningbo Women & Children's Hospital
Jiaxing University Affiliated Women and Children Hospital
Shaoxing Women's and Children's Hospital

Investigators

  • Principal Investigator: Jiajun Zhu, Women's Hospital School of Medicine Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO2021-1366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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