Survival Model for Preterm Infants

NCT05381285 | Unknown

• 3 other identifiers: 20/AUG/796628704922/PR/0147
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Mortality; Morbidity;Newborn

Outcome Measures

Primary Outcomes (2)

• Mortality

  In-hospital mortality

  40-weeks

• Mortality or major morbidity

  In-hospital outcomes

  40-weeks

Interventions

No intervention OTHER

Non-interventional study

Eligibility Criteria

• Age: 0 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Cardiff University: collaborator
• Swansea Bay University Health Board: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Central Study Contacts

Mallinath Chakraborty, PhD

CONTACT

+442921843387; chakrabortym@cardiff.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 19, 2022
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)