Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
417 participants
OBSERVATIONAL
2024-01-01
2024-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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NIRS (Near-infrared spectroscopy) group of the COSGOD III trial
A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. Preterm neonates less than 32 weeks gestation were randomly assigned to standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.
In the NIRS-group 252 (82.9%) out of 303 neonates (gestational-age, median (interquartile-range): 28.9 (26.9-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)
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.
Control group of the COSGOD III trial
A multi-center, multi-national randomized-controlled trial was performed in 11 centers in Europe and Canada. Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) during immediate transition (first 15 minutes after birth) and resuscitation.
In the Control-group 238 (78.5%) out of 304 neonates (gestational-age, median (interquartile-range): 28.6 (26.6-30.6) weeks) survived without cerebral injury until term age or discharge. (primary outcome of the COSGOD III trial)
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Months
30 Months
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Medical University of Vienna
OTHER
Vittore Buzzi Children's Hospital
OTHER
University Hospital Tuebingen
OTHER
University College Cork
OTHER
University Hospital Freiburg
OTHER
Poznan University of Medical Sciences
OTHER
University Medical Centre Ljubljana
OTHER
IRCCS Burlo Garofolo
OTHER
University of Alberta
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Gerhard Pichler, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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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
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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References
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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.
Other Identifiers
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36-041 ex 23/24
Identifier Type: -
Identifier Source: org_study_id
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