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

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: Recruiting
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Behavioral: internet plus model; Behavioral: control

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Rong Chen, doctor; Phone Number: 18985180888; Email: chenronggy@foxmail.com

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: Rong Chen, doctor; Phone Number: 18985180888; Email: 1841552025@qq.com
    • Guiyang, Guizhou, China, 550001
      • Not yet recruiting
      • The First Affiliated Hospital of Guizhou University of Chinese
      • Contact: Yang Yang, Bachelor

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence of severe hyperbilirubinemia	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	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

Outcome Measure	Measure Description	Time Frame
Incidence rate of acute bilirubin encephalopathy	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	sum total serum bilirubin of hospitalized newborns at admission/Total number of hospitalized newborns	10,01,2023 to 10,01,2024
Follow-up satisfaction	Parents' comments of participating in the study	10,01,2023 to 10,01,2024
Average economic cost of treatment	Treatment and transportation costs and so on	10,01,2023 to 10,01,2024

Collaborators and Investigators

• Sponsor: Guizhou Provincial People's Hospital
• Investigators: Principal Investigator: Rong Chen, doctor, Guizhou Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): October 10, 2024
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: follow-up; neonatal jaundice; internet plus model; severe hyperbilirubinemia
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Jaundice, Neonatal
• Other Study ID 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