2 Year Follow up of COSGOD III

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

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.

Sponsors & Collaborators

• Medical University Innsbruck

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Vittore Buzzi Children's Hospital

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• University Medical Centre Ljubljana

  collaborator OTHER

• IRCCS Burlo Garofolo

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Medical University of Graz

  lead OTHER

Principal Investigators

• Gerhard Pichler, Prof · Medical University of Graz

Eligibility

Min Age

18 Months

Max Age

30 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2024-10-09

Completion

2024-12-31

Countries

• Austria
• Canada
• Germany
• Ireland
• Italy
• Poland
• Slovenia

Study Locations