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Deficits, NeurologicNCT05134116

SafeBoosC III Two-year Follow-up

An observational study of Deficits, Neurologic and Extreme Prematurity, run by Gorm Greisen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 30 months
What is being tested?
Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
How many people
1,601 participants
Where
1 siteDenmark
Study dates
23 Sep 2021to 19 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 30 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Righospitalet (The University Hospital, Copenhagen)

    Copenhagen

Other trials in Denmark

About this study

Official title: Cerebral Near-infrared Spectroscopy Monitoring Versus Treatment as Usual for Extremely Preterm Infants: a Protocol for the Follow-up Study for the SafeBoosC-III Trial

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.

Read the detailed description

In the SafeBoosC-III trial, the objective is to investigate the effect of treatment based on cerebral near-infrared spectroscopy (NIRS) monitoring of brain oxygenation compared with treatment as usual in extremely preterm infants. The primary outcome of the trial is death or survival with severe brain injury at 36 weeks' postmenstrual age. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. Therefore, if treatment based on cerebral NIRS monitoring decreases the risks of death or survival with severe brain injury, it is important to document if the beneficial effect persists into early childhood, in the form of better neurodevelopmental outcome. Furthermore, it is also important to identify evidence of unexpected harms. It would be unfortunate if cerebral NIRS monitoring became standard practice without good evidence that long-term patient-relevant benefits outweigh possible harms. As the SafeBoosC-III trial intends to randomise 1600 infants, there is potential to achieve sufficient power for a meaningful assessment of the experimental intervention's effect on long-term neurodevelopment, as well as an evaluation of unexpected harms. The objective of the SafeBoosC III follow-up study is to investigate the benefits and harms of treatment guided by cerebral NIRS monitoring of brain oxygenation in extremely preterm infants during the first 72 hours of life, assessed at two years' corrected age. The hypothesis is that the intervention will decrease a composite of death or moderate-or-severe neurodevelopmental disability at two years' corrected age, and/or increase cognitive function in survivors assessed by the Bayley III/IV test, with insignificant harms. The investigators aim to collect data on as many children as possible and will do this by collecting clinical data from health care records as well as answers from parental questionnaires.

Being tested
Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
Keywords
Neurodevelopmental disability, Cerebral palsy, Neurosensory deficits, Cognitive disability, Follow up study, Extremely preterm birth, Near infrared spectroscopy (NIRS), Cerebral oximetry
Medical subject headings
Neurologic Manifestations, Brain Injuries, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: To be assessed at two years of corrected age

  2. 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)

    Measured: To be assessed at two years of corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start23 Sep 2021
  3. Primary completion19 Oct 2024
  4. Study completion19 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134116
Sponsor's protocol ID
SafeBoosC-IIIfu
Status last verified
Nov 2024
First submitted
19 Oct 2021
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rasmussen MIS, Hansen ML, Pellicer A, Hyttel-Sorensen S, Ergenekon E, Szczapa T, Hagmann C, Naulaers G, Mintzer J, Fumagalli M, Dimitriou G, Dempsey E, Tkaczyk J, Fredly S, Heuchan AM, Pichler G, Fuchs H, Nesargi S, Hahn GH, Piris-Borregas S, Sirc J, Alsina-Casanova M, Stocker M, Ozkan H, Sarafidis K, Kraus NJ, Karen T, Rzepecka-Weglarz B, Oguz SS, Thewissen L, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Schneider J, de Las Cuevas MI, Hedegaard SS, Zafra P, Bender L, Farquharson S, Ochoda-Mazur A, Lecart C, El-Khuffash A, Chathasaigh CN, Miletin J, Papathoma E, Vesoulis Z, Serrao F; SafeBoosC-III Follow-Up Writing Group for the SafeBoosC-III Follow-Up Collaborator Group; Cornette L, Yasa B, Klamer A, Barcos-Munoz F, Boetti T, Cetinkaya M, Montasser M, Hatzidaki E, Bokiniec R, Marciniak S, Chalak L, Rao SA, Sadowska-Krawczenko I, Serrano-Vinuales I, Krolak-Olejnik B, Plomgaard AM, Hansen BM, Olsen MH, Gluud C, Jakobsen JC, Greisen G. Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial. JAMA Pediatr. 2026 Jun 1;180(6):619-627. doi: 10.1001/jamapediatrics.2026.1066.

    PubMed 42008246

  • 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;27(1):100. doi: 10.1186/s13063-025-09392-7.

    PubMed 41491571

  • 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.

    PubMed 37805539

Questions about this trial

What is this clinical trial studying?

An observational study of Deficits, Neurologic and Extreme Prematurity, run by Gorm Greisen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death or moderate-or-severe neurodevelopmental disability (time frame: To be assessed at two years of corrected age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05134116, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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