Neonatal and Long Term Outcomes of Preterm Born Children in Flanders

University Hospital, Ghent1 site in 1 country2,037 target enrollmentJuly 1, 2017

ConditionsPremature Birth

Overview

Phase: N/A
Intervention: Not specified
Conditions: Premature Birth
Sponsor: University Hospital, Ghent
Enrollment: 2037
Locations: 1
Primary Endpoint: Prediction model
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A register and prediction model will be developed to predict the outcome of preterm labour and birth.

Registry

clinicaltrials.gov

Start Date

July 1, 2017

End Date

December 2032

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children

Exclusion Criteria

•Patients who choose not to participate in the research.
•Intra-uterine prelabour fetal death.
•Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome.
•Postpartum transfer/outborn.

Outcomes

Primary Outcomes

Prediction model

Time Frame: 2017 - 2030

The prediction tool for true preterm labour (TPL) will be developed using individual risk factors, symptomatology, tocography, cervical change and a biomarker test, followed by a decision-making model, both based on individual data, evidence and experience.

Time Frame: 2017 - 2030

A multicentre, multidisciplinary register will be created to provide a source of valuable information on obstetrical and neonatal practices and link them with obstetrical, neonatal and long-term outcomes of preterm labour and birth