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NCT05181319 Clinical Trial

Prediction for Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:
Development of a Nomogram for Predicting Bronchopulmonary Dysplasia in Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05181319
Other study ID # QFS-2018-1201
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2022

Study information
Verified date December 2021
Source Qianfoshan Hospital
Contact MU Kai, Doctor
Phone 15634883957
Email mkbest@yeah.net
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Day
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• occurrence of bronchopulmonary dysplasia
We observe the incidence of bronchopulmonary dysplasia

Locations
Country Name City State
China Qianfoshan Hospital Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Kai Mu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary bronchopulmonary dysplasia occurs Number of cases of bronchopulmonary dysplasia 2 weeks after admission
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