Hyperbilirubinemia, NeonatalNCT04251286
Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network
An observational study of Hyperbilirubinemia, Neonatal, run by Nanjing Medical University at 1 site in China.
Trial summary
At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Apr 2025
- How long will I take part?
- 2 Years
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: For the research on the natural history of jaundice via mobile network, the selected population is healthy newborns with gestational age ≥35 weeks and weight ≥2000g, and those without phototherapy or hospital intervention. For the study of the online registry for severe hyperbilirubinemia, the study population is gestational age ≥35 weeks, weight ≥2000g, only hospitalized for jaundice, and the serum total bilirubin reached the threshold of exchange transfusion (≤3 days) or the serum total bilirubin ≥20mg / dl (>3 days).
Who may be able to join
- Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
Who cannot join
- Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210000
Han Shuping, PHD, +86-025-52226561, shupinghan@njmu.edu.cn
Yu Zhangbin, PHD, +86-025-52226567, yuzhangbin@126.com
About this study
Official title: Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network：A Multicentrd, Prospective, Open, Clinical Study
At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.
Read the detailed description
This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, screening, follow-up
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What is being measured
The primary outcome is the main question the study is designed to answer.
To record the TCB values of Chinese newborns within 28 days after birth.
Transcutaneous bilirubin (TcB) values will be recorded so as to establish transcutaneous bilirubin nomogram in healthy Chinese term and late-preterm infants at <28 days of age.
Measured: 12 months
The comprehensive prognosis of infants
To investigate the comprehensive prognosis of infants with severe hyperbilirubinemia at the corrected age of 2 years in a real-world setting in Jiangsu Province.
Measured: 60 months
Secondary outcomes (3)
Risk factors of extreme hyperbilirubinemia
Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.
Measured: 36 months
The incidence of neurological sequelae.
To assess the clinical outcome at 2 years of corrected age in cases treated with and without exchange transfusion when TSB is at a level of the threshold
Measured: 60 months
The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.
To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 May 2020
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, Changzhou Maternal and Child Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Affiliated Hospital of Jiangsu University, Suqian First Hospital, Jiangyin People's Hospital, Nantong Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Jiangsu Taizhou People's Hospital, Yangzhou Maternity and Child Health Care Hospital, Yangzhou University
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Han Shuping, PHD, Study director, Nanjing Maternity and Child Health Care HospitalYu Zhangbin, PHD, Study director, Nanjing Maternity and Child Health Care HospitalDeng Xiaoyi, MD, Principal investigator, Xuzhou Maternity and Child Health Care HospitalHu Yuhua, PHD, Principal investigator, Jiangsu Women and Children Health HospitalWang Jinxiu, PHD, Principal investigator, Changzhou Maternal and Child Care HospitalLi Qianqian, MD, Principal investigator, Xuzhou Maternity and Child Health Care HospitalGao Yan, MD, Principal investigator, Lianyungang Maternity and Child Health Care HospitalLu Hongyan, MD, Principal investigator, Affiliated Hospital of Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251286
- Sponsor's protocol ID
- NMU-FY2018-54
- Status last verified
- Oct 2021
- First submitted
- 16 Jan 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is an open project, and the collected data and information will be provided to all participating centers after review by the data management committee. Anyone interested in this research can contact us directly.
Publications
Li Q, Deng X, Yan J, Sun X, Dong X, Chen X, Han S, Huo J, Yu Z. Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study. BMJ Open. 2021 Feb 5;11(2):e040797. doi: 10.1136/bmjopen-2020-040797.
PubMed 33550236
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network：A Multicentrd, Prospective, Open, Clinical Study
- ClinicalTrials.gov ID
- NCT04251286
- Acronym / sponsor ID
- NMU-FY2018-54
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, screening, follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Xuzhou Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, Changzhou Maternal and Child Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Affiliated Hospital of Jiangsu University, Suqian First Hospital, Jiangyin People's Hospital, Nantong Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Jiangsu Taizhou People's Hospital, Yangzhou Maternity and Child Health Care Hospital, Yangzhou University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 31 Jan 2020 (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.
At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.
Detailed description
This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- For the research on the natural history of jaundice via mobile network, the selected population is healthy newborns with gestational age ≥35 weeks and weight ≥2000g, and those without phototherapy or hospital intervention. For the study of the online registry for severe hyperbilirubinemia, the study population is gestational age ≥35 weeks, weight ≥2000g, only hospitalized for jaundice, and the serum total bilirubin reached the threshold of exchange transfusion (≤3 days) or the serum total bilirubin ≥20mg / dl (>3 days).
Key inclusion criteria (1 listed)
- Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
Key exclusion criteria (1 listed)
- Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.
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
To record the TCB values of Chinese newborns within 28 days after birth.
Time frame: 12 months
Transcutaneous bilirubin (TcB) values will be recorded so as to establish transcutaneous bilirubin nomogram in healthy Chinese term and late-preterm infants at <28 days of age.
The comprehensive prognosis of infants
Time frame: 60 months
To investigate the comprehensive prognosis of infants with severe hyperbilirubinemia at the corrected age of 2 years in a real-world setting in Jiangsu Province.
3 secondary outcomes
Risk factors of extreme hyperbilirubinemia
Time frame: 36 months
The incidence of neurological sequelae.
Time frame: 60 months
The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 33550236Li Q, Deng X, Yan J, Sun X, Dong X, Chen X, Han S, Huo J, Yu Z. Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study. BMJ Open. 2021 Feb 5;11(2):e040797. doi: 10.1136/bmjopen-2020-040797.
- Individual participant dataSharing planned: Yes. The study is an open project, and the collected data and information will be provided to all participating centers after review by the data management committee. Anyone interested in this research can contact us directly.
Related trials for Hyperbilirubinemia, Neonatal
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Active, not recruiting
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
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.
Han Shuping, PHD study director
Nanjing Maternity and Child Health Care Hospital
Yu Zhangbin, PHD study director
Nanjing Maternity and Child Health Care Hospital
Deng Xiaoyi, MD principal investigator
Xuzhou Maternity and Child Health Care Hospital
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 Hyperbilirubinemia, Neonatal, run by Nanjing Medical University 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 1 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 1 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Shuping, PHD (+86-025-52226561, shupinghan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To record the TCB values of Chinese newborns within 28 days after birth. (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT04251286, which also lists 1 linked publication.
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 1 Nov 2021.