CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,601 enrolled
Drug / intervention
Modify cardio-respiratory support to avoid cerebral hypoxia +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03770741
NCT03770741N/ACompleted
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Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants

Gorm Greisen·interventional·Posted Dec 10, 2018·Updated Dec 20, 2021

In Brief

A clinical study evaluating Modify cardio-respiratory support to avoid cerebral hypoxia and Treatment as usual for Infant, Extremely Premature and 3 related conditions. Completed, enrolled 1,601 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
CountriesDenmark
CollaboratorsCopenhagen Trial Unit, Center for Clinical Intervention Research, Elsass Foundation

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 10, 2018
Enrollment StartJun 20, 2019
Primary CompletionDec 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago

Interventions

Modify cardio-respiratory support to avoid cerebral hypoxiaother

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

Treatment as usualother

Monitoring and treatment according to local guidelines and practice