Survival Model for Preterm Infants

NCT ID: NCT05381285

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Mortality Morbidity;Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiff University

OTHER

Sponsor Role collaborator

Swansea Bay University Health Board

OTHER

Sponsor Role collaborator

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Mallinath Chakraborty, PhD

Role: CONTACT

+442921843387

Facility Contacts

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Cathy Green

Role: primary

Other Identifiers

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287049

Identifier Type: OTHER

Identifier Source: secondary_id

22/PR/0147

Identifier Type: OTHER

Identifier Source: secondary_id

20/AUG/7966

Identifier Type: -

Identifier Source: org_study_id

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