Death, Neurodevelopmental Disability
Conditions
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).
Interventions
OTHERNIRS 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
Medical University Innsbruck
Medical University of Vienna
Vittore Buzzi Children's Hospital
University Hospital Tuebingen
University College Cork
University Hospital Freiburg
Poznan University of Medical Sciences
University Medical Centre Ljubljana
IRCCS Burlo Garofolo
University of Alberta
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 30 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | 2 years (18 to 30 months) corrected age | Mortality mentioned in Patients charts |
| Conditions of neurodevelopmental outcome - Bailey Scores | 2 years (18 to 30 months) corrected age | Testing or information from Patients charts Bailey Scores |
| Conditions of neurodevelopmental outcome- PARCA-R Score | 2 years (18 to 30 months) corrected age | Testing or information from Patients charts PARCA-R Scores |
| Conditions of neurodevelopmental outcome - GMFC Scores | 2 years (18 to 30 months) corrected age | Testing or information from Patients charts GMFC Scores |
| Weight | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Sex | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Head circumference | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Long term medications | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Presence of chronic diseases | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Gestational age | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
| Length | 2 years (18 to 30 months) corrected age | Documented in Patients charts |
Countries
Austria, Canada, Germany, Ireland, Italy, Poland, Slovenia
Outcome results
None listed