NCT05181319

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

4.9 years

First QC Date

December 18, 2021

Last Update Submit

December 18, 2021

Conditions

Keywords

Bronchopulmonary Dysplasia; Infants;Nomogram

Outcome Measures

Primary Outcomes (1)

  • bronchopulmonary dysplasia occurs

    Number of cases of bronchopulmonary dysplasia

    2 weeks after admission

Study Arms (2)

bronchopulmonary dysplasia group

infants diagnosed with bronchopulmonary dysplasia

Other: occurrence of bronchopulmonary dysplasia

no bronchopulmonary dysplasia

infants not diagnosed with bronchopulmonary dysplasia

Other: occurrence of bronchopulmonary dysplasia

Interventions

We observe the incidence of bronchopulmonary dysplasia

bronchopulmonary dysplasia groupno bronchopulmonary dysplasia

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 251400, China

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • MU Kai, Doctor

    Qianfoshan Hospital

    STUDY DIRECTOR

Central Study Contacts

MU Kai, Doctor

CONTACT

ZHANG Jing

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 18, 2021

First Posted

January 6, 2022

Study Start

January 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 6, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations