NCT06141733

2 Year Follow up of COSGOD III

2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 417 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Months – 30 Months
• Healthy volunteers: Not accepted

Summary

The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available. However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire. Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).

Conditions

• Neurodevelopmental Disability
• Death

Interventions

Type	Name	Description
OTHER	NIRS group	Standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-10-09
• Completion: 2024-12-31
• First posted: 2023-11-21
• Last updated: 2025-03-13

Locations

11 sites across 7 countries: Austria, Canada, Germany, Ireland, Italy, Poland, Slovenia