SafeBoosC III Two-year Follow-up

Extreme Prematurity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134116
• Other study ID #: SafeBoosC-IIIfu
• Status: Recruiting
• Start date: September 23, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Gorm Greisen, Professor
• Phone: +45 35 45 50 24
• Email: gorm.greisen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 30 Months

Eligibility

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.

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• Extreme Prematurity
• Neurologic Manifestations

Intervention

Other:
• Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
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

Locations

Country	Name	City	State
Denmark	Righospitalet (The University Hospital, Copenhagen)	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Gorm Greisen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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

External Links

•   Trial and Follow up website