the Difference of Follow-up Methods of Neonatal Jaundice (NJFU)

October 31, 2023 updated by: Guizhou Provincial People's Hospital

Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia

The goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. There are two kinds of follow-up methods in the investigators clinical practice. The one is internet plus follow-up model, the other is conventional clinic follow-up method. Parents of the participant neonates can choose one by themselves. After parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guizhou
      • Anshun, Guizhou, China, 561001
        • Not yet recruiting
        • People'S Hospital of Anshun City Guizhou Province
        • Contact:
          • Lu Guo Linang, Master
          • Phone Number: 13698528760
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Guiyang, Guizhou, China, 550001
        • Not yet recruiting
        • The First Affiliated Hospital of Guizhou University of Chinese
        • Contact:
          • Yang Yang, Bachelor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

neoborns, gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks

Description

Inclusion Criteria:

  1. Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks;
  2. Presence of skin yellowing, percutaneous measurement of jaundice or serum bilirubin concentration less than the phototherapy warning value for the same gestational age and day age group;
  3. The vital signs are stable and meet the discharge requirements;
  4. Agree to participate in this project and sign an informed consent form;
  5. Parents have a certain understanding ability to cooperate in this study;

Exclusion Criteria:

  1. Direct bilirubin ≥34mmol/L;
  2. Increased hepatic enzyme level more than twice of normal value;
  3. Those infants who have developed bilirubin encephalopathy or neurological damage due to other reasons before follow-up;
  4. Unable to continue follow-up due to other diseases.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observation group
Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up
Behavioral: internet plus model
Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up
control group
follow-up by conventional methods ； hospital or community follow-up depending on arrangement
Behavioral: control
follow-up by conventional methods; hospital or community follow-up depending on arrangement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of severe hyperbilirubinemia
Time Frame: 10,01,2023 to 10,01,2024
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
10,01,2023 to 10,01,2024
Newborn follow-up rate
Time Frame: 10,01,2023 to 10,01,2024
Number of newborns who completed the follow-up program/total number of follow-up newborns
10,01,2023 to 10,01,2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence rate of acute bilirubin encephalopathy
Time Frame: 10,01,2023 to 10,01,2024
Number of infants with acute bilirubin encephalopathy/total number of follow-up newborns
10,01,2023 to 10,01,2024
Mean bilirubin level at admission
Time Frame: 10,01,2023 to 10,01,2024
sum total serum bilirubin of hospitalized newborns at admission/Total number of hospitalized newborns
10,01,2023 to 10,01,2024
Follow-up satisfaction
Time Frame: 10,01,2023 to 10,01,2024
Parents' comments of participating in the study
10,01,2023 to 10,01,2024
Average economic cost of treatment
Time Frame: 10,01,2023 to 10,01,2024
Treatment and transportation costs and so on
10,01,2023 to 10,01,2024

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guizhou Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rong Chen, doctor, Guizhou Provincial People's Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEO20230802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Scientific publishing

IPD Sharing Time Frame

12,31,2025

IPD Sharing Access Criteria

open

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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