Survival Model for Preterm Infants

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mortality; Morbidity;Newborn
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Mallinath Chakraborty, PhD; Phone Number: +442921843387; Email: chakrabortym@cardiff.ac.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
    • Contact: Cathy Green

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The whole population of preterm infants born before 34 weeks of gestation for 8 years (2011-2018) in Wales will be included in the retrospective cohort.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	In-hospital mortality	40-weeks
Mortality or major morbidity	In-hospital outcomes	40-weeks

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: Cardiff University; Swansea Bay University Health Board

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20/AUG/7966; 287049 (Other Identifier: IRAS project ID); 22/PR/0147 (Other Identifier: REC reference)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No