Survival Model for Preterm Infants | NCT05381285

Studies
Survival Model for Preterm Infants

NCT05381285

Sponsor

Cardiff and Vale University Health Board

Status

Unknown status

Last Update Posted

Aug 31, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Mortality
Morbidity;Newborn

Interventions

No intervention

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
287049	Other Identifier	IRAS project ID
22/PR/0147	Other Identifier	REC reference

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 1, 2022

First Submission Date that Met QC Criteria

May 18, 2022

First Posted Date

May 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2023

Last Update Posted Date

Aug 31, 2023Actual

Name	Class
Cardiff University	OTHER
Swansea Bay University Health Board	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Non-interventional study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Weeks

Maximum Age

16 Weeks

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mallinath Chakraborty, PhD	Contact	+442921843387		chakrabortym@cardiff.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Wales		Cardiff		CF14 4XW	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided