the Difference of Follow-up Methods of Neonatal Jaundice

Neonatal Jaundice Clinical Trial

— NJFU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075290
• Other study ID #: NEO20230802
• Status: Recruiting
• Start date: October 10, 2023
• Est. completion date: May 10, 2025

Study information

• Verified date: October 2023
• Source: Guizhou Provincial People's Hospital
• Contact: Rong Chen, doctor
• Phone: 18985180888
• Email: chenronggy[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 10, 2025
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 16 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Behavioral:
• internet plus model
Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up
• control
follow-up by conventional methods; hospital or community follow-up depending on arrangement

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Guizhou Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Follow-up satisfaction	Parents' comments of participating in the study	10,01,2023 to 10,01,2024
Secondary	Average economic cost of treatment	Treatment and transportation costs and so on	10,01,2023 to 10,01,2024