Clinical trial NCT06075290: the Difference of Follow-up Methods of Neonatal Jaundice
Official title: Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Jaundice
Keywords: neonatal jaundice
follow-up
internet plus model
severe hyperbilirubinemia
Lead sponsor: Guizhou Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neoborns, gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of severe hyperbilirubinemia
timeFrame: 10,01,2023 to 10,01,2024
measure: Newborn follow-up rate
timeFrame: 10,01,2023 to 10,01,2024
Secondary outcomes:
measure: Incidence rate of acute bilirubin encephalopathy
timeFrame: 10,01,2023 to 10,01,2024
measure: Mean bilirubin level at admission
timeFrame: 10,01,2023 to 10,01,2024
measure: Follow-up satisfaction
timeFrame: 10,01,2023 to 10,01,2024
measure: Average economic cost of treatment
timeFrame: 10,01,2023 to 10,01,2024
Other outcomes:
Locations:
city: Anshun
country: China
facility: People's Hospital of Anshun City Guizhou Province
state: Guizhou
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guizhou University of Chinese
state: Guizhou
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
Study officials:
affiliation: Guizhou Provincial People's Hospital
name: Rong Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: