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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| Medical University of Vienna | OTHER |
| Vittore Buzzi Children's Hospital | OTHER |
| University Hospital Tuebingen |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS group | Other | Standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years (18 to 30 months) corrected age |
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| Measure | Description | Time Frame |
|---|---|---|
| Death | Mortality mentioned in Patients charts | 2 years (18 to 30 months) corrected age |
| Conditions of neurodevelopmental outcome - Bailey Scores | Testing or information from Patients charts Bailey Scores |
Inclusion Criteria:
Exclusion Criteria:
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Preterm neonates included in COSGOD III trial
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Pichler, Prof | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Austria | ||||
| Medical University Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36693654 | Background | 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. |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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| 2 years (18 to 30 months) corrected age |
| Conditions of neurodevelopmental outcome- PARCA-R Score | Testing or information from Patients charts PARCA-R Scores | 2 years (18 to 30 months) corrected age |
| Conditions of neurodevelopmental outcome - GMFC Scores | Testing or information from Patients charts GMFC Scores | 2 years (18 to 30 months) corrected age |
| Weight | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Length | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Head circumference | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Long term medications | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Presence of chronic diseases | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Sex | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| Gestational age | Documented in Patients charts | 2 years (18 to 30 months) corrected age |
| 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 |