Jaundice, NeonataljaundiceNCT03805165
Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China
An observational study of Jaundice, Neonatal, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal
- How many people
- 2,977 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2019
- 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and near term newborns, whos gestational age was more than 35 weeks(≥35)
Who may be able to join
- gestational age more than 35 weeks(≥35) -
Who cannot join
- all kinds of congenital diseases, infants with pathologic jaundice
- -
Trial locations and contacts
1 site in 1 country.
About this study
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.
Read the detailed description
This was a multi-centre prospective study. All infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland China in 2019. A total of 20839 transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. The primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. The effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.
- Conditions
- Jaundice, Neonatal
- Keywords
- nighttime light exposure ，neonatal jaundice，China
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neonate | transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hour-specific Transcutaneous Bilirubin Level
make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data
Measured: 1 year
whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life
whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 2,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yang jie, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805165
- Sponsor's protocol ID
- Guangdong WCH
- Acronym
- jaundice
- Status last verified
- Nov 2024
- First submitted
- 25 Dec 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China
- ClinicalTrials.gov ID
- NCT03805165
- Acronym / sponsor ID
- jaundice / Guangdong WCH
- Conditions
- Jaundice, Neonatal
- Keywords
- nighttime light exposure ，neonatal jaundice，China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,977 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Jan 2019 (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.
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.
Detailed description
This was a multi-centre prospective study. All infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland China in 2019. A total of 20839 transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. The primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. The effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neonate | – | –transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and near term newborns, whos gestational age was more than 35 weeks(≥35)
Key inclusion criteria (1 listed)
- gestational age more than 35 weeks(≥35) -
Key exclusion criteria (2 listed)
- all kinds of congenital diseases, infants with pathologic jaundice
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hour-specific Transcutaneous Bilirubin Level
Time frame: 1 year
make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data
whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life
Time frame: 2019
whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, Neonatal, run by Guangdong Women and Children Hospital at 1 site 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hour-specific Transcutaneous Bilirubin Level (time frame: 1 year). 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 3 Dec 2024.