Skip to main content
Clinical Trials/NCT05381285
NCT05381285
Not Yet Recruiting
N/A

Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)

Cardiff and Vale University Health Board1 site in 1 country5,000 target enrollmentJune 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mortality
Sponsor
Cardiff and Vale University Health Board
Enrollment
5000
Locations
1
Primary Endpoint
Mortality or major morbidity
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Preterm infants born alive at or less than 34 weeks of gestation.
  • Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
  • Mother normally resident in Wales
  • Exclusion Criteria
  • The mother is normally resident in England (detailed maternal data not available)
  • Congenital anomaly noted at birth (alters the natural probability of outcomes)
  • Duplicate episodes for an individual infant

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mortality or major morbidity

Time Frame: 40-weeks

In-hospital outcomes

Mortality

Time Frame: 40-weeks

In-hospital mortality

Study Sites (1)

Loading locations...

Similar Trials