Bronchopulmonary DysplasiaNCT05181319
Prediction for Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by Kai Mu at 1 site in China.
Trial summary
In this Multi-center study performed from January 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. LASSO regression was used to select variables for the risk model. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- occurrence of bronchopulmonary dysplasia
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2022
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department. The data was collected from medical records. Patients with GAs <36 weeks, and who were admitted to the NICU within 24 h after birth were included, and the length of stay was more than 1 week.patients with inherited disease, metabolic disorders and multiple malformations were excluded.
Who may be able to join
- Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department.
- Patients with gestational age <36 weeks
- admitted to the NICU within 24 h after birth
- the length of stay was more than 1 week
Who cannot join
- patients with inherited disease, metabolic disorders and multiple malformations.
Trial locations and contacts
1 site in 1 country.
ZHANG Jing contact
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital
Jinan, Shandong, 251400
MU Kai, mkbest@yeah.net
About this study
Official title: Development of a Nomogram for Predicting Bronchopulmonary Dysplasia in Infants
In this Multi-center study performed from January 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. LASSO regression was used to select variables for the risk model. Then, we used multivariable logistic regression to build the prediction model incorporating these selected features. Discrimination was assessed by the C-index, and and calibration of the model was assessed by and calibration curve and the Hosmer-Lemeshow test.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- occurrence of bronchopulmonary dysplasia
- Keywords
- Bronchopulmonary Dysplasia; Infants；Nomogram
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occurrence of bronchopulmonary dysplasiaOther
We observe the incidence of bronchopulmonary dysplasia
| Study group | Role | What they receive |
|---|---|---|
| bronchopulmonary dysplasia group | infants diagnosed with bronchopulmonary dysplasia Receives: Other: occurrence of bronchopulmonary dysplasia | |
| no bronchopulmonary dysplasia | infants not diagnosed with bronchopulmonary dysplasia Receives: Other: occurrence of bronchopulmonary dysplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia occurs
Number of cases of bronchopulmonary dysplasia
Measured: 2 weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Jan 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Mu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Mu, Qianfoshan Hospital
- Investigators
- MU Kai, Doctor, Study director, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181319
- Sponsor's protocol ID
- QFS-2018-1201
- Status last verified
- Dec 2021
- First submitted
- 18 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Nomogram for Predicting Bronchopulmonary Dysplasia in Infants
- ClinicalTrials.gov ID
- NCT05181319
- Acronym / sponsor ID
- QFS-2018-1201
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia; Infants；Nomogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Kai MuUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Jan 2022 (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.
In this Multi-center study performed from January 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. LASSO regression was used to select variables for the risk model. Then, we used multivariable logistic regression to build the prediction model incorporating these selected features. Discrimination was assessed by the C-index, and and calibration of the model was assessed by and calibration curve and the Hosmer-Lemeshow test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchopulmonary dysplasia group | – | Other: occurrence of bronchopulmonary dysplasiainfants diagnosed with bronchopulmonary dysplasia |
| no bronchopulmonary dysplasia | – | Other: occurrence of bronchopulmonary dysplasiainfants not diagnosed with bronchopulmonary dysplasia |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department. The data was collected from medical records. Patients with GAs <36 weeks, and who were admitted to the NICU within 24 h after birth were included, and the length of stay was more than 1 week.patients with inherited disease, metabolic disorders and multiple malformations were excluded.
Key inclusion criteria (4 listed)
- Patients were recruited from Multi-center Collaborative Group Hospital Neonatal Intensive Care Unit (NICU) Department.
- Patients with gestational age <36 weeks
- admitted to the NICU within 24 h after birth
- the length of stay was more than 1 week
Key exclusion criteria (1 listed)
- patients with inherited disease, metabolic disorders and multiple malformations.
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 |
|---|---|---|
| occurrence of bronchopulmonary dysplasiaWe observe the incidence of bronchopulmonary dysplasia | Other | bronchopulmonary dysplasia group, no bronchopulmonary dysplasia |
Primary outcome
bronchopulmonary dysplasia occurs
Time frame: 2 weeks after admission
Number of cases of bronchopulmonary dysplasia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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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.
ZHANG Jing contact
MU Kai, Doctor study director
Qianfoshan 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 Bronchopulmonary Dysplasia, run by Kai Mu 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 4 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 6 Jan 2022. 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 MU Kai, Doctor (15634883957, mkbest@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bronchopulmonary dysplasia occurs (time frame: 2 weeks after admission). 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 6 Jan 2022.