Prediction for Bronchopulmonary Dysplasia

December 18, 2021 updated by: Kai Mu

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 251400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with inherited disease, metabolic disorders and multiple malformations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bronchopulmonary dysplasia group
infants diagnosed with bronchopulmonary dysplasia
Other: occurrence of bronchopulmonary dysplasia
We observe the incidence of bronchopulmonary dysplasia
no bronchopulmonary dysplasia
infants not diagnosed with bronchopulmonary dysplasia
Other: occurrence of bronchopulmonary dysplasia
We observe the incidence of bronchopulmonary dysplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bronchopulmonary dysplasia occurs
Time Frame: 2 weeks after admission
Number of cases of bronchopulmonary dysplasia
2 weeks after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Mu

Investigators

  • Study Director: MU Kai, Doctor, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

December 18, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 18, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QFS-2018-1201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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