the Difference of Follow-up Methods of Neonatal Jaundice

Recruiting

• Conditions: Neonatal Jaundice
• Interventions: Behavioral: control; Behavioral: internet plus model

• Registration Number: NCT06075290
• Lead Sponsor: Guizhou Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study Start: 2023-10-10
• Study First Posted: 2023-10-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-10-10
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	control	follow-up by conventional methods ； hospital or community follow-up depending on arrangement
Observation group	internet plus model	Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up

Primary Outcome Measures

Name	Time	Method
Newborn follow-up rate	10,01,2023 to 10,01,2024	Number of newborns who completed the follow-up program/total number of follow-up newborns
Incidence of severe hyperbilirubinemia	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

Secondary Outcome Measures

Name	Time	Method
Incidence rate of acute bilirubin encephalopathy	10,01,2023 to 10,01,2024	Number of infants with acute bilirubin encephalopathy/total number of follow-up newborns
Follow-up satisfaction	10,01,2023 to 10,01,2024	Parents' comments of participating in the study
Average economic cost of treatment	10,01,2023 to 10,01,2024	Treatment and transportation costs and so on
Mean bilirubin level at admission	10,01,2023 to 10,01,2024	sum total serum bilirubin of hospitalized newborns at admission/Total number of hospitalized newborns

Trial Locations

Locations (3)

People's Hospital of Anshun City Guizhou Province; 🇨🇳 Anshun, Guizhou, China

Guizhou Provincial People's Hospital; 🇨🇳 Guiyang, Guizhou, China

The First Affiliated Hospital of Guizhou University of Chinese; 🇨🇳 Guiyang, Guizhou, China