Quality ImprovementNCT03824990
Multi-center Clinical Study on Neonatal Hyperbilirubinemia
A study testing Quality improvement of management of neonatal jaundice in people with Quality Improvement and Hyperbilirubinemia, Neonatal, run by Nanjing Medical University at 1 site in China.
Trial summary
Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Quality Improvement, Hyperbilirubinemia, Neonatal
- What is being tested?
- Quality improvement of management of neonatal jaundice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 15 Oct 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
Who cannot join
- Infants admitted to a higher level of intervention before discharge.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210000
About this study
Official title: Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates
Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.
Read the detailed description
Through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for China's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.
- Conditions
- Quality Improvement, Hyperbilirubinemia, Neonatal
- Being tested
- Quality improvement of management of neonatal jaundice
- Keywords
- Quality improvement, Hyperbilirubinemia, screening, follow-up
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement of management of neonatal jaundiceBehavioural
During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.
| Study group | Role | What they receive |
|---|---|---|
| Before-intervention phase | No intervention | All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals. |
| Intervention phase | Experimental | All the healthy infants who were admitted from September 2018 to February 2019 to the Well Baby nurse of different hospitals.During this phase,multiple intervention bundles of quality improvement will be implemented. Receives: Behavioral: Quality improvement of management of neonatal jaundice |
| Sustainability intervention phase | Experimental | All the healthy infants who were admitted from March 2019 to August 2019 to the Well Baby nurse of different hospitals.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented. Receives: Behavioral: Quality improvement of management of neonatal jaundice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of bilirubin encephalopathy
Measured: 18 months
Secondary outcomes (4)
The incidence of severe hyperbilirubinemia
Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL
Measured: 18 months
The rate of lost to follow-up
The rate of lost to follow-up for jaundice after discharge from well-baby nursery
Measured: 18 months
The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia
Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth
Measured: 42 months
Medical costs in patients with severe hyperbilirubinemia
To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.
Measured: 18 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 2019
- Study start1 Mar 2018
- Primary completion31 Aug 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality ImprovementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- JiLin Women and Children Health Hospital, Shandong Provincial Hospital, Shan Dong Qian Fo Shan Hospital, Shan Dong Liao Cheng Hospital, Guangxi Maternal and Child Health Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Yin Chuan Maternity and Child Health Hospital
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Shuping Han, PHD, Study director, Nanjing Maternity and Child Health Care HospitalZhangbin Yu, PHD, Principal investigator, Nanjing Maternity and Child Health Care HospitalZhiyong Sun, PHD, Principal investigator, JiLin Women and Children Health HospitalHaiyan Cai, PHD, Principal investigator, Qinhuangdao Maternal and Child Health Care HospitalYonghui Yu, MD, Principal investigator, Shandong Provincial HospitalXin Yuan, MD, Principal investigator, Shan Dong Qian Fo Shan HospitalJin Qian, MD, Principal investigator, Shan Dong Liao Cheng HospitalJimei Wang, PHD, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824990
- Sponsor's protocol ID
- NMU-FY2018-72
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates
- ClinicalTrials.gov ID
- NCT03824990
- Acronym / sponsor ID
- NMU-FY2018-72
- Conditions
- Quality Improvement, Hyperbilirubinemia, Neonatal
- Keywords
- Quality improvement, Hyperbilirubinemia, screening, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- JiLin Women and Children Health Hospital, Shandong Provincial Hospital, Shan Dong Qian Fo Shan Hospital, Shan Dong Liao Cheng Hospital, Guangxi Maternal and Child Health Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Yin Chuan Maternity and Child Health Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 31 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.
Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.
Detailed description
Through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for China's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before-intervention phase | No intervention | –All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals. |
| Intervention phase | Experimental | Behavioral: Quality improvement of management of neonatal jaundiceAll the healthy infants who were admitted from September 2018 to February 2019 to the Well Baby nurse of different hospitals.During this phase,multiple intervention bundles of quality improvement will be implemented. |
| Sustainability intervention phase | Experimental | Behavioral: Quality improvement of management of neonatal jaundiceAll the healthy infants who were admitted from March 2019 to August 2019 to the Well Baby nurse of different hospitals.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.
Key exclusion criteria (1 listed)
- Infants admitted to a higher level of intervention before discharge.
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 |
|---|---|---|
| Quality improvement of management of neonatal jaundiceDuring the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods. | Behavioural | Intervention phase, Sustainability intervention phase |
Primary outcome
The incidence of bilirubin encephalopathy
Time frame: 18 months
4 secondary outcomes
The incidence of severe hyperbilirubinemia
Time frame: 18 months
The rate of lost to follow-up
Time frame: 18 months
The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia
Time frame: 42 months
Medical costs in patients with severe hyperbilirubinemia
Time frame: 18 months
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 1 Nov 2021.
Related trials for Quality Improvement
Active, not recruitingPhase 2
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Metastatic Malignant Female Reproductive System Neoplasm
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
RecruitingObservational study
Patient Satisfaction Following Multidisciplinary Cancer Care Assessment in Day Hospital.
Patient Satisfaction, Cancer
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
Active, not recruitingObservational study
Quality ImprOvement stUdy ouTpatient Surgery rapID movE
Postoperative Recovery
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.
Shuping Han, PHD study director
Nanjing Maternity and Child Health Care Hospital
Zhangbin Yu, PHD principal investigator
Nanjing Maternity and Child Health Care Hospital
Zhiyong Sun, PHD principal investigator
JiLin Women and Children Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement of management of neonatal jaundice in people with Quality Improvement and 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: finished, 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?
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?
The incidence of bilirubin encephalopathy (time frame: 18 months). 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 1 Nov 2021.