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Safeguarding the Brain of Our Smallest Infants Phase III

NCT03770741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1601

Last updated 2021-12-20

No results posted yet for this study

Summary

the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.

Conditions

  • Infant, Extremely Premature
  • Brain Injuries
  • Death, Brain
  • Death; Neonatal

Interventions

OTHER

Modify cardio-respiratory support to avoid cerebral hypoxia

modification of cardio-respiratory support based on an evidence-based treatment guideline

OTHER

Treatment as usual

Monitoring and treatment according to local guidelines and practice

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Elsass Foundation

    collaborator OTHER

  • Gorm Greisen

    lead OTHER

Principal Investigators

  • Gorm Greisen, MD, Prof · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-12-16
Completion
2021-12-16

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 NCT03770741 on ClinicalTrials.gov