Clinical trial NCT06141733: 2 Year Follow up of COSGOD III
Official title: 2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disability
Death
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Medical University of Vienna
name: Vittore Buzzi Children's Hospital
name: University Hospital Tuebingen
name: University College Cork
name: University Hospital Freiburg
name: Poznan University of Medical Sciences
name: University Medical Centre Ljubljana
name: IRCCS Burlo Garofolo
name: University of Alberta
First posted: 2023-11-21
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm neonates included in COSGOD III trial

Brief 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).


Eligibility criteria: Inclusion Criteria:

* \> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Exclusion Criteria:

* \< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Primary outcomes:
measure: Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age
timeFrame: 2 years (18 to 30 months) corrected age
Secondary outcomes:
Other outcomes:
measure: Death
timeFrame: 2 years (18 to 30 months) corrected age
measure: Conditions of neurodevelopmental outcome - Bailey Scores
timeFrame: 2 years (18 to 30 months) corrected age
measure: Conditions of neurodevelopmental outcome- PARCA-R Score
timeFrame: 2 years (18 to 30 months) corrected age
measure: Conditions of neurodevelopmental outcome - GMFC Scores
timeFrame: 2 years (18 to 30 months) corrected age
measure: Weight
timeFrame: 2 years (18 to 30 months) corrected age
measure: Length
timeFrame: 2 years (18 to 30 months) corrected age
measure: Head circumference
timeFrame: 2 years (18 to 30 months) corrected age
measure: Long term medications
timeFrame: 2 years (18 to 30 months) corrected age
measure: Presence of chronic diseases
timeFrame: 2 years (18 to 30 months) corrected age
measure: Sex
timeFrame: 2 years (18 to 30 months) corrected age
measure: Gestational age
timeFrame: 2 years (18 to 30 months) corrected age
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Vienna
country: Austria
facility: Medical University Vienna
city: Edmonton
country: Canada
facility: University of Alberta
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Tübingen
country: Germany
facility: Centre for Ped. Clinical Studies Tübingen
city: Cork
country: Ireland
facility: University College Cork
city: Milano
country: Italy
facility: Ospedale dei Bambini "V.Buzzi" Milano
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health, IRCCS Burlo Garofolo
city: Poznań
country: Poland
facility: Ginekologiczno Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Medical University of Graz
name: Gerhard Pichler, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pichler G, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law B, Urlesberger B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Schwaberger B, Klebermass-Schrehof K, Schmolzer GM; COSGOD III study group. Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial. BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.