2 Year Follow up of COSGOD III

NCT06141733 | Completed

• 1 other identifier: 36-041 ex 23/24
• Study Type: observational
• Target: 417
• Locations: 7 countries
• Sites: 11

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).

Conditions

Neurodevelopmental Disability; Death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Death

  2 years (18 to 30 months) corrected age

• Conditions of neurodevelopmental outcome - Bailey Scores

  2 years (18 to 30 months) corrected age

• Conditions of neurodevelopmental outcome- PARCA-R Score

  2 years (18 to 30 months) corrected age

Study Arms (2)

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

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)

Interventions

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.

NIRS (Near-infrared spectroscopy) group of the COSGOD III trial

Eligibility Criteria

• Age: 18 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm neonates included in COSGOD III trial

You may qualify if:

• \> 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

You may not qualify if:

• \< 50% 2 year neurodevelopmental outcome assessment at 2 years (18 to 30 months)

Sponsors & Collaborators

• Medical University of Graz: lead
• Medical University Innsbruck: collaborator
• Medical University of Vienna: collaborator
• Vittore Buzzi Children's Hospital: collaborator
• University Hospital Tuebingen: collaborator
• University College Cork: collaborator
• University Hospital Freiburg: collaborator
• Poznan University of Medical Sciences: collaborator
• University Medical Centre Ljubljana: collaborator
• IRCCS Burlo Garofolo: collaborator
• University of Alberta: collaborator

Study Sites (11)

Medical University of Graz

Graz, Austria

Location

Medical University Innsbruck

Innsbruck, Austria

Location

Medical University Vienna

Vienna, Austria

Location

University of Alberta

Edmonton, Canada

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Centre for Ped. Clinical Studies Tübingen

Tübingen, Germany

Location

University College Cork

Cork, Ireland

Location

Ospedale dei Bambini "V.Buzzi" Milano

Milan, Italy

Location

Institute for Maternal and Child Health, IRCCS Burlo Garofolo

Trieste, Italy

Location

Ginekologiczno Położniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, Poland

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related 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.

  PMID: 36693654 BACKGROUND

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Pichler, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2024
• Primary Completion: October 9, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (2); AU (3); IE (1); PL (1); SL (1); CA (1); DE (2)