2 Year Follow up of COSGOD III (COSGODIII-FU)

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

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).

Study Overview

• Status: Completed
• Conditions: Death; Neurodevelopmental Disability
• Intervention / Treatment: Other: NIRS group

• Study Type: Observational
• Enrollment (Actual): 417

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Preterm neonates included in COSGOD III trial

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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.
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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Medical University of Vienna; University of Alberta; Poznan University of Medical Sciences; Medical University Innsbruck; University Hospital Tuebingen; University Hospital Freiburg; University College Cork; University Medical Centre Ljubljana; IRCCS Burlo Garofolo; Vittore Buzzi Children's Hospital
• Investigators: Principal Investigator: Gerhard Pichler, Prof, Medical University of Graz

Publications and helpful links

General Publications

• 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. doi: 10.1136/bmj.p1102.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): October 9, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 36-041 ex 23/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No