2 Year Follow up of COSGOD III

Study Overview
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Brief Summary
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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).

Official Title
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2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial

Conditions
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Death, Neurodevelopmental Disability

Intervention / Treatment
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* Other: NIRS group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIRS (Near-infrared spectroscopy) group of the COSGOD III trial<br>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) | Other: NIRS group<br>* Standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.<br>|
| Control group of the COSGOD III trial<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |