2 Year Follow up of COSGOD III

Death Clinical Trial

— COSGODIII-FU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141733
• Other study ID #: 36-041 ex 23/24
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: Gerhard Pichler
• Phone: +43 316 385 80520
• Email: gerhard.pichler[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 607
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 30 Months

Eligibility

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)

Related Conditions & MeSH terms

• Death
• Neurodevelopmental Disability

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Medical University Innsbruck	Innsbruck
Austria	Medical University Vienna	Vienna
Canada	University of Alberta	Edmonton
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Centre for Ped. Clinical Studies Tübingen	Tübingen
Ireland	University College Cork	Cork
Italy	Ospedale dei Bambini "V.Buzzi" Milano	Milano
Italy	Institute for Maternal and Child Health, IRCCS Burlo Garofolo	Trieste
Poland	Ginekologiczno Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego	Poznan
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (11)

Lead Sponsor	Collaborator
Medical University of Graz	IRCCS Burlo Garofolo, Medical University Innsbruck, Medical University of Vienna, Poznan University of Medical Sciences, University College Cork, University Hospital Freiburg, University Hospital Tuebingen, University Medical Centre Ljubljana, University of Alberta, Vittore Buzzi Children's Hospital

Countries where clinical trial is conducted

Austria,  Canada,  Germany,  Ireland,  Italy,  Poland,  Slovenia, 

References & Publications (1)

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. Erratum In: BMJ. 2023 May 15;381:p1102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	Mortality mentioned in Patients charts	2 years (18 to 30 months) corrected age
Other	Conditions of neurodevelopmental outcome - Bailey Scores	Testing or information from Patients charts Bailey Scores	2 years (18 to 30 months) corrected age
Other	Conditions of neurodevelopmental outcome- PARCA-R Score	Testing or information from Patients charts PARCA-R Scores	2 years (18 to 30 months) corrected age
Other	Conditions of neurodevelopmental outcome - GMFC Scores	Testing or information from Patients charts GMFC Scores	2 years (18 to 30 months) corrected age
Other	Weight	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Length	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Head circumference	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Long term medications	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Presence of chronic diseases	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Sex	Documented in Patients charts	2 years (18 to 30 months) corrected age
Other	Gestational age	Documented in Patients charts	2 years (18 to 30 months) corrected age
Primary	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