Survival Model for Preterm Infants

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05381285
• Other study ID #: 20/AUG/7966
• Secondary ID: 28704922/PR/0147
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Cardiff and Vale University Health Board
• Contact: Mallinath Chakraborty, PhD
• Phone: +442921843387
• Email: chakrabortym[@]cardiff.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 16 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Morbidity;Newborn
• Mortality

Intervention

Other:
• No intervention
Non-interventional study

Locations

Country	Name	City	State
United Kingdom	University Hospital of Wales	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Cardiff University, Swansea Bay University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	In-hospital mortality	40-weeks
Primary	Mortality or major morbidity	In-hospital outcomes	40-weeks