SafeBoosC III Two-year Follow-up

NCT05134116 | Completed

• 1 other identifier: SafeBoosC-IIIfu
• Study Type: observational
• Target: 1,601
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neurodevelopmental disability; Cerebral palsy; Neurosensory deficits; Cognitive disability; Follow up study; Extremely preterm birth; Near infrared spectroscopy (NIRS); Cerebral oximetry

Outcome Measures

Primary Outcomes (2)

• Death or moderate-or-severe neurodevelopmental disability

  A child will be classified with moderate-or-severe neurodevelopmental disability if they have been diagnosed with cerebral palsy, a cognitive function score below -2 standard deviations from the norm, hearing impairment, or vision impairment or from data from a parental questionnaire.

  To be assessed at two years of corrected age

• Mean Bayley III/IV cognitive score

  The cognitive scores from the Bayley III/IV assessment will constitute a single continuous outcome measure (higher scores meaning better outcomes)

  To be assessed at two years of corrected age

Other Outcomes (4)

• Daily medication the last two months (yes/no)

  To be assessed at two years of corrected age

• Any other chronic illness (defined as any problem which has been diagnosed by a doctor and which 1) is expected to last more than a few months, 2) causes problems in everyday life, or 3) is a risk of early death or disability),

  To be assessed at two years of corrected age

• Growth measurements

  To be assessed at two years of corrected age

Interventions

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

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

Eligibility Criteria

• Age: 12 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born below 28 weeks of gestation and randomised in the SafeBoosC-III trial

You may qualify if:

• Participation in the SafeBoosC-III trial and enrollment in a neonatal intensive care unit (NICU) taking part in the follow-up study, with parental consent according to local regulations.

You may not qualify if:

• Parental objection to the use of their child's data in the follow-up study.

Sponsors & Collaborators

• Gorm Greisen: lead

Study Sites (1)

Righospitalet (The University Hospital, Copenhagen)

Copenhagen, Denmark

Location

Related Publications (2)

• Rasmussen MIS, Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Tkaczyk J, Fuchs H, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Plomgaard AM, Hansen BM, Olsen MH, Jakobsen JC, Greisen G. Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial. Trials. 2026 Jan 5. doi: 10.1186/s13063-025-09392-7. Online ahead of print.

  PMID: 41491571 DERIVED

• Rasmussen MI, Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Cheng G, Tkaczyk J, Fuchs H, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Plomgaard AM, Hansen BM, Jakobsen JC, Greisen G. Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial. Trials. 2023 Oct 7;24(1):653. doi: 10.1186/s13063-023-07653-x.

  PMID: 37805539 DERIVED

Related Links

• Trial and Follow up website

MeSH Terms

Conditions

Neurologic Manifestations; Brain Injuries; Cerebral Palsy

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cheif Consultant Neonatologist

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 24, 2021
• Study Start: September 23, 2021
• Primary Completion: October 19, 2024
• Study Completion: October 19, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

DK (1)