Safeguarding the Brain of Our Smallest Infants Phase III

NCT03770741 | Completed DMC

• 1 other identifier: SafeBoosC-DP-363
• Study Type: interventional
• Target: 1,601
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Near-infrared spectroscopy; NIRS; Cerebral oximetry; Extremely preterm; Brain injury; Mortality; Treatment guideline

Outcome Measures

Primary Outcomes (1)

• Severe brain injury or death

  A composite of severe brain injury detected on any one of a series of cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age or death at 36 weeks postmenstrual age

  From birth to 36 weeks postmenstrual age

Other Outcomes (5)

• Major neonatal morbidities

  From birth to 36 weeks postmenstrual age

• Bronchopulmonary dysplasia

  From birth to 36 weeks postmenstrual age

• Retinopathy of prematurity

  From birth to 36 weeks postmenstrual age

Study Arms (2)

Monitoring of cerebral oxygenation

EXPERIMENTAL

Modify cardio-respiratory support to avoid cerebral hypoxia

Other: Modify cardio-respiratory support to avoid cerebral hypoxia

Treatment as usual

OTHER

Treatment according local guidelines and practices.

Other: Treatment as usual

Interventions

Modify cardio-respiratory support to avoid cerebral hypoxia OTHER

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

Monitoring of cerebral oxygenation

Treatment as usual OTHER

Monitoring and treatment according to local guidelines and practice

Treatment as usual

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born with postmenstrual age less than 28 weeks
• Signed informed consent, unless the NICU has chosen to use 'opt-out' or deferred consent as consent method.

You may not qualify if:

• Decision not to conduct full life support
• No possibility to place cerebral NIRS oximeter within six hours after birth

Sponsors & Collaborators

• Gorm Greisen: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Elsass Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (7)

• Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.

  PMID: 25569128 BACKGROUND

• Rasmussen MIS, Hansen ML, Peters C, Greisen G; SafeBoosC-III Trial Group. Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III. Trials. 2024 Oct 23;25(1):711. doi: 10.1186/s13063-024-08530-x.

  PMID: 39444031 DERIVED

• Olsen MH, Hansen ML, Lange T, Gluud C, Thabane L, Greisen G, Jakobsen JC; SafeBoosC-III Trial Group. Detailed statistical analysis plan for a secondary Bayesian analysis of the SafeBoosC-III trial: a multinational, randomised clinical trial assessing treatment guided by cerebral oximetry monitoring versus usual care in extremely preterm infants. Trials. 2023 Nov 16;24(1):737. doi: 10.1186/s13063-023-07720-3.

  PMID: 37974280 DERIVED

• 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, Cheng G, 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, Hopper AO, Karen T, Rzepecka-Weglarz B, Oguz SS, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Truttmann AC, de Las Cuevas I, Agergaard P, Zafra P, Bender L, Lauterbach R, Lecart C, de Buyst J, El-Khuffash A, Curley A, Vaccarello OO, Miletin J, Papathoma E, Vesoulis Z, Vento G, Cornette L, Lopez LS, Yasa B, Klamer A, Agosti M, Baud O, Mastretta E, Cetinkaya M, McCall K, Zeng S, Hatzidaki E, Bargiel A, Marciniak S, Gao X, Huijia L, Chalak L, Yang L, Rao SA, Xu X, Gonzalez BL, Wilinska M, Yin Z, Sadowska-Krawczenko I, Serrano-Vinuales I, Krolak-Olejnik B, Ybarra MM, Morales-Betancourt C, Korcek P, Teresa-Palacio M, Mosca F, Hergenhan A, Koksal N, Tsoni K, Kadri MM, Knopfli C, Rafinska-Wazny E, Akin MS, Nordvik T, Peng Z, Kersin SG, Thewissen L, Alarcon A, Healy D, Urlesberger B, Bas M, Baumgartner J, Skylogianni E, Karadyova V, Valverde E, Bergon-Sendin E, Kucera J, Pisoni S, Wang L, Smits A, Sanchez-Salmador R, Rasmussen MI, Olsen MH, Jensen AK, Gluud C, Jakobsen JC, Greisen G. Cerebral Oximetry Monitoring in Extremely Preterm Infants. N Engl J Med. 2023 Apr 20;388(16):1501-1511. doi: 10.1056/NEJMoa2207554.

  PMID: 37075142 DERIVED

• Hansen ML, Rasmussen MI, Rubin S, Pellicer A, Cheng G, Xu X, Zhaoqing Y, Zoffmann V, Greisen G. Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III. Trials. 2020 Apr 23;21(1):356. doi: 10.1186/s13063-020-4206-6.

  PMID: 32326953 DERIVED

• 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, Guimaraes H, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Lemmers P, Fredly S, Szczapa T, Austin T, Jakobsen JC, Greisen G. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. Trials. 2019 Dec 30;20(1):811. doi: 10.1186/s13063-019-3955-6.

  PMID: 31888764 DERIVED

• Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sorensen S, Heuchan AM, Hagmann C, Dimitriou G, Pichler G, Naulaers G, Cheng G, Vilan A, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Fredly S, Szczapa T, Lange T, Jakobsen JC, Greisen G. Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants. Trials. 2019 Dec 19;20(1):746. doi: 10.1186/s13063-019-3756-y.

  PMID: 31856902 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Brain Injuries; Brain Death; Perinatal Death

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gorm Greisen, MD, Prof

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the experimental intervention, no blinding can be done for the clinical staff and the parents. Outcome assessment of mortality will not be blinded, but the diagnosis and classification of brain injury and the entry of this into the eCRF, will be done by a person that is blinded to group allocation. Principal investigators must develop a local procedure description that describe how this is done. The local procedure description must be approved by the sponsor. Furthermore, mortality will be checked by Good Clinical Practice (GCP) through source data verification in all patients. The data managers, statisticians and those drawing conclusions will be blinded to treatment allocation. Data management will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Pediatrics

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: June 20, 2019
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)