the Difference of Follow-up Methods of Neonatal Jaundice

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Behavioral: internet plus model
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 16 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group<br>Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up | Behavioral: internet plus model<br>* Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up<br>|
| control group<br>follow-up by conventional methods ； hospital or community follow-up depending on arrangement | Behavioral: control<br>* follow-up by conventional methods; hospital or community follow-up depending on arrangement<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal jaundice, follow-up, internet plus model, severe hyperbilirubinemia