Survival Model for Preterm Infants

Cardiff and Vale University Health Board

Status: Not yet enrolling

Conditions: Mortality; Morbidity;Newborn

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05381285

22/PR/0147 (Other Identifier)

287049 (Other Identifier)

20/AUG/7966

Details and patient eligibility

About

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

Enrollment: 5,000 estimated patients

Sex: All

Ages: Under 16 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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