Survival Model for Preterm Infants

Not yet recruiting

• Conditions: Mortality; Morbidity;Newborn

• Registration Number: NCT05381285
• Lead Sponsor: Cardiff and Vale University Health Board

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Study Start: 2024-06-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Preterm infants born alive at or less than 34 weeks of gestation.
2. Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
3. Mother normally resident in Wales

Exclusion Criteria

1. The mother is normally resident in England (detailed maternal data not available)
2. Congenital anomaly noted at birth (alters the natural probability of outcomes)
3. Duplicate episodes for an individual infant

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or major morbidity	40-weeks	In-hospital outcomes
Mortality	40-weeks	In-hospital mortality

Trial Locations

Locations (1)

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom