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Completed

NCT Number: NCT06141733

2 Year Follow up of COSGOD III

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).

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Key information

Conditions

Neurodevelopmental Disability Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 month–30 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Composite of survival without moderate to severe neurodevelopmental disability (NDD) at 2 years (18 to 30 months) corrected age

    Time frame: 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 outcomes

  1. Death

    Time frame: 2 years (18 to 30 months) corrected age

    Mortality mentioned in Patients charts

  2. Conditions of neurodevelopmental outcome - Bailey Scores

    Time frame: 2 years (18 to 30 months) corrected age

    Testing or information from Patients charts Bailey Scores

  3. Conditions of neurodevelopmental outcome- PARCA-R Score

    Time frame: 2 years (18 to 30 months) corrected age

    Testing or information from Patients charts PARCA-R Scores

  4. Conditions of neurodevelopmental outcome - GMFC Scores

    Time frame: 2 years (18 to 30 months) corrected age

    Testing or information from Patients charts GMFC Scores

  5. Weight

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  6. Length

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  7. Head circumference

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  8. Long term medications

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  9. Presence of chronic diseases

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  10. Sex

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

  11. Gestational age

    Time frame: 2 years (18 to 30 months) corrected age

    Documented in Patients charts

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: COSGODIII-FU

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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