NJFU: the Difference of Follow-up Methods of Neonatal Jaundice
Study Details
Study Description
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 our 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 they signed informed consent, we recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then we analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to accept.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks;
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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;
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The vital signs are stable and meet the discharge requirements;
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Agree to participate in this project and sign an informed consent form;
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Parents have a certain understanding ability to cooperate in this study;
Exclusion Criteria:
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Direct bilirubin ≥34mmol/L;
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Increased hepatic enzyme level more than twice of normal value;
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Those infants who have developed bilirubin encephalopathy or neurological damage due to other reasons before follow-up;
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Unable to continue follow-up due to other diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | People's Hospital of Anshun City Guizhou Province | Anshun | Guizhou | China | 561001 |
| 2 | The First Affiliated Hospital of Guizhou University of Chinese | Guiyang | Guizhou | China | 550001 |
| 3 | Guizhou Provincial People's Hospital | Guiyang | Guizhou | China | 550002 |
Sponsors and Collaborators
- Guizhou Provincial People's Hospital
Investigators
- Principal Investigator: Rong Chen, doctor, Guizhou Provincial People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEO20230802