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SafeBoosC III Two-year Follow-up

NCT05134116 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1601

Last updated 2024-11-07

No results posted yet for this study

Summary

The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741). The investigators will collect data when the patients are two years of corrected age from routine standardised follow up assessments, parental questionnaires as well as informal assessments. The study will commence in September 2021, and will expect to include all 72 sites across 18 countries, which take part of the SafeBoosC-III clinical trial.

Conditions

  • Deficits, Neurologic
  • Extreme Prematurity
  • Brain Damage

Interventions

OTHER

Treatment as usual + cerebral oximetry monitoring the first 72 hours of life

SafeBoosC - Safeguarding the Brain of Our Smallest Children - an Investigator-initiated Randomised, Blinded, Multinational, Phase II Feasibility Clinical Trial on Near-infrared Spectroscopy Monitoring Combined With Defined Treatment Guidelines Versus Standard Monitoring and Treatment as Usual in Premature Infants

Sponsors & Collaborators

  • Gorm Greisen

    lead OTHER

Eligibility

Min Age
12 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2024-10-19
Completion
2024-10-19

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134116 on ClinicalTrials.gov