Neonatal JaundiceNJFUNCT06075290
the Difference of Follow-up Methods of Neonatal Jaundice
An observational study of Neonatal Jaundice, run by Guizhou Provincial People's Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 0 days to 16 weeks
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- internet plus model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 10 Oct 2023to 10 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 16 weeks
- All sexes
- No healthy volunteers
- Child
Study population: neoborns, gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
People's Hospital of Anshun City Guizhou Province
Anshun, Guizhou, 561001
Lu Guo Linang, Master, 13698528760
- Not yet recruiting
The First Affiliated Hospital of Guizhou University of Chinese
Guiyang, Guizhou, 550001
Yang Yang, Bachelor
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Rong Chen, doctor, 18985180888, 1841552025@qq.com
About this study
Official title: Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia
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.
- Conditions
- Neonatal Jaundice
- Being tested
- internet plus model, control
- Keywords
- neonatal jaundice, follow-up, internet plus model, severe hyperbilirubinemia
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet plus modelBehavioural
Intelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up
controlBehavioural
follow-up by conventional methods; hospital or community follow-up depending on arrangement
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Intelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up Receives: Behavioral: internet plus model | |
| control group | follow-up by conventional methods ； hospital or community follow-up depending on arrangement Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe hyperbilirubinemia
The peak concentration of serum bilirubin is more than the exchange criteria of same gestational age and day age group
Measured: 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
Measured: 10,01,2023 to 10,01,2024
Secondary outcomes (4)
Incidence rate of acute bilirubin encephalopathy
Number of infants with acute bilirubin encephalopathy/total number of follow-up newborns
Measured: 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
Measured: 10,01,2023 to 10,01,2024
Follow-up satisfaction
Parents' comments of participating in the study
Measured: 10,01,2023 to 10,01,2024
Average economic cost of treatment
Treatment and transportation costs and so on
Measured: 10,01,2023 to 10,01,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start10 Oct 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Chen, doctor, Principal investigator, Guizhou Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075290
- Sponsor's protocol ID
- NEO20230802
- Acronym
- NJFU
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific publishing
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT06075290
- Acronym / sponsor ID
- NJFU / NEO20230802
- Conditions
- Neonatal Jaundice
- Keywords
- neonatal jaundice, follow-up, internet plus model, severe hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Behavioral: internet plus modelIntelligent jaundice instrument and Internet plus system for home monitoring and remote follow-up |
| control group | – | Behavioral: controlfollow-up by conventional methods ； hospital or community follow-up depending on arrangement |
Who may qualify
- Ages
- 0 days to 16 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neoborns, gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet plus modelIntelligent transcutaneous bilirubin meter and Internet plus model for neonatal jaundice monitoring at home and remote follow-up | Behavioural | Observation group |
| controlfollow-up by conventional methods; hospital or community follow-up depending on arrangement | Behavioural | control group |
Primary outcome
Incidence of severe hyperbilirubinemia
Time frame: 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
Time frame: 10,01,2023 to 10,01,2024
Number of newborns who completed the follow-up program/total number of follow-up newborns
4 secondary outcomes
Incidence rate of acute bilirubin encephalopathy
Time frame: 10,01,2023 to 10,01,2024
Mean bilirubin level at admission
Time frame: 10,01,2023 to 10,01,2024
Follow-up satisfaction
Time frame: 10,01,2023 to 10,01,2024
Average economic cost of treatment
Time frame: 10,01,2023 to 10,01,2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Yes. Scientific publishing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Chen, doctor principal investigator
Guizhou Provincial People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Jaundice, run by Guizhou Provincial People's Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Chen, doctor (18985180888, chenronggy@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe hyperbilirubinemia (time frame: 10,01,2023 to 10,01,2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.