SafeBoosC III Two-year Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Damage; Extreme Prematurity; Deficits, Neurologic
• Intervention / Treatment: Other: Treatment as usual + cerebral oximetry monitoring the first 72 hours of life

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.

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Gorm Greisen, Professor; Phone Number: +45 35 45 50 24; Email: gorm.greisen@regionh.dk
• Study Contact Backup: Name: Marie Isabel Skov Rasmussen, PhD student; Phone Number: +45 35 45 50 24; Email: marie.isabel.skov.rasmussen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Righospitalet (The University Hospital, Copenhagen)
    • Contact: Gitte Hahn, MD, PhD; Phone Number: +45 35 45 50 24; Email: gitte.hahn@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily medication the last two months (yes/no)	Will be assessed based on the childs health care records or a parental questionnaire	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),	Will be assessed based on the childs health care records or a parental questionnaire	To be assessed at two years of corrected age
Growth measurements	Mean head circumference, mean height and mean body weight. Will be assessed based on the childs health care records	To be assessed at two years of corrected age
Components of the co-primary outcomes	All components of the co-primary outcomes will be reported for the two groups separately as well as effect estimates with confidence intervals and will be taken into consideration when interpreting the main results	To be assessed at two years of corrected age

Collaborators and Investigators

• Sponsor: Gorm Greisen

Publications and helpful links

Helpful Links

• Trial and Follow up website

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral palsy; Cerebral oximetry; Neurodevelopmental disability; Neurosensory deficits; Cognitive disability; Follow up study; Extremely preterm birth; Near infrared spectroscopy (NIRS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Neurologic Manifestations
• Other Study ID Numbers: SafeBoosC-IIIfu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No