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).
Study Type
OBSERVATIONAL
Enrollment
417
Standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.
Medical University of Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Medical University Vienna
Vienna, Austria
University of Alberta
Edmonton, Canada
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Centre for Ped. Clinical Studies Tübingen
Tübingen, Germany
University College Cork
Cork, Ireland
Ospedale dei Bambini "V.Buzzi" Milano
Milan, Italy
Institute for Maternal and Child Health, IRCCS Burlo Garofolo
Trieste, Italy
Ginekologiczno Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, Poland
...and 1 more locations
Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age
A child will be classified with moderate-or-severe NDD, if any of the four following conditions are present: Cognitive or language disability Bayley II test cognitive scale cut-off will be \< 85 Bayley III/IV test, cognitive or language composite scale cut-off will be \< 85 PARCA R non-verbal cognition or language score cut-off will be \< 70 If no standardized developmental assessment is available, informal assessment is possible: less than 5 words Cerebral palsy Gross Motor Function Classification Score (GMFCS) ≥ 2 If no GMFCS is available, informal assessment is possible: Not able to walk alone Visual impairment: Impairment even with glasses or only being able to perceive light or being blind (one or two eyes) Hearing impairment Impairment defined as hearing loss corrected with aids or being deaf
Time frame: 2 years (18 to 30 months) corrected age
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