the Difference of Follow-up Methods of Neonatal Jaundice

NCT06075290 | Unknown DMC

• 1 other identifier: NEO20230802
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neonatal Jaundice

Keywords

neonatal jaundice; follow-up; internet plus model; severe hyperbilirubinemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence rate of acute bilirubin encephalopathy

  10,01,2023 to 10,01,2024

• Mean bilirubin level at admission

  10,01,2023 to 10,01,2024

• Follow-up satisfaction

  10,01,2023 to 10,01,2024

• Average economic cost of treatment

  10,01,2023 to 10,01,2024

Study Arms (2)

Observation group

Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up

Behavioral: internet plus model

control group

follow-up by conventional methods ； hospital or community follow-up depending on arrangement

Behavioral: control

Interventions

internet plus model BEHAVIORAL

Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up

Observation group

control BEHAVIORAL

follow-up by conventional methods; hospital or community follow-up depending on arrangement

control group

Eligibility Criteria

• Age: 0 Days - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks;
• 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;
• The vital signs are stable and meet the discharge requirements;
• Agree to participate in this project and sign an informed consent form;
• Parents have a certain understanding ability to cooperate in this study;

You may not qualify if:

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

Sponsors & Collaborators

• Guizhou Provincial People's Hospital: lead

Study Sites (3)

People's Hospital of Anshun City Guizhou Province

Anshun, Guizhou, 561001, China

NOT YET RECRUITING

The First Affiliated Hospital of Guizhou University of Chinese

Guiyang, Guizhou, 550001, China

NOT YET RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Rong Chen, doctor

  Guizhou Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Chen, doctor

CONTACT

18985180888; chenronggy@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: October 10, 2023
• Primary Completion: October 10, 2024
• Study Completion: May 10, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 12,31,2025
• Access Criteria: open

Locations

CN (3)