An observational study in Neonatal Jaundice, sponsored by Guizhou Provincial People's Hospital. Recruiting at 3 sites in China. Open to participants aged 0 Days to 16 Weeks. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Guizhou Provincial People's Hospital · Observational
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Guizhou Provincial People's Hospital is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
neoborns, gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up
Behavioral: internet plus model
follow-up by conventional methods ； hospital or community follow-up depending on arrangement
Behavioral: control
Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up
follow-up by conventional methods; hospital or community follow-up depending on arrangement
Incidence of severe hyperbilirubinemia
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
Time frame: 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
Time frame: 10,01,2023 to 10,01,2024
Incidence rate of acute bilirubin encephalopathy
Number of infants with acute bilirubin encephalopathy/total number of follow-up newborns
Time frame: 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
Time frame: 10,01,2023 to 10,01,2024
Follow-up satisfaction
Parents' comments of participating in the study
Time frame: 10,01,2023 to 10,01,2024
Average economic cost of treatment
Treatment and transportation costs and so on
Time frame: 10,01,2023 to 10,01,2024
Plan to share: Yes — Scientific publishing
Supporting information: Study protocol, Clinical study report
Time frame: 12,31,2025
Access criteria: open
No publications or documents are linked to this record.
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Guizhou Provincial People's Hospital