Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

Hypoxia Clinical Trial

— SafeBoosC-IIIv  

Official title:

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05907317
• Other study ID #: SafeBoosC-IIIv
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: June 2023
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the SafeBoosC-IIIv trial is to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. The hypothesis is that the intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

Inclusion Criteria:

• Gestational age more than 28+0 weeks

• Postnatal age less than 28 days

• Expected to receive mechanical ventilation for at least 24 hours, as judged by the physician intending to randomise

• Equipoise as regards the need for cerebral oximetry

• Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method.

Exclusion Criteria:

• No signed parental informed consent (if prior consent is used), or lack of a record that the clinician has explained the trial to the parents and the parents agreed (if 'opt-out' is used,)

• Suspicion of or confirmed brain injury or disorder (e.g. perinatal asphyxia, cerebral haemorrhage, cerebral malformation, genetic or metabolic disease)

• A cerebral oximeter is not available

• Newborns with congenital heart malformations who is likely to need surgery.

Related Conditions & MeSH terms

• Hypoxia
• Infant, Newborn, Diseases

Intervention

Device:
• Cerebral oximetry monitoring device
The experimental group will receive cerebral oximetry added to usual care, if possible before or, as soon as possible and within six hours after mechanical ventilation has been initiated, and continuing until the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, until 28 days after birth, or until death. The devices used are approved for clinical use in newborns and will be used according to the user manuals provided by the manufacturers. Furthermore, all clinical staff will be offered web-based training and certification that covers the principles of cerebral oximetry, practical application, as well as pathophysiology, and relevant interventions in the case of low cerebral oxygenation.

Other:
• Usual care
Usual care offered to newborns in the control group will be offered equally in the experimental group (e.g. antibiotics; nutrition; etc.). There will be no attempt to standardize 'usual care' among centres.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Individual Serious Adverse Events	as listed in the secondary outcome	28 days
Other	Days alive outside hospital within the 28 first days of life		28 days
Other	Cerebral palsy	defined as Global Motor Function Classification System level 2 or above, at two years of corrected age.	2 years
Other	Sensory deficit	defined as any degree of vision or hearing impairment, at two years of corrected age.	2 years
Other	Mortality	Mortality at two years of corrected age.	2 years
Other	Use of medication	Use of medication during the last two months, at two years of corrected age.	2 years
Primary	A composite of death from any cause or moderate to severe neurodevelopmental disability	There will be two co-primary outcomes, a composite dichotomized outcome and a continuous outcome: A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following; cerebral palsy with Global Motor Function Classification System level 2 or higher; a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD); hearing loss corrected with aids or worse; or; vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.	2 years
Primary	Parental questionnaires	Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment.; • Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome).	18-30 months
Secondary	Serious adverse events	One or more Serious Adverse Events after randomisation and within the 28 first days of life, i.e. one or more of the following; Death from any cause; Any brain injury diagnosed by imaging; Seizures treated with antiepileptic medicine; Necrotising enterocolitis (NEC) Bells grade 2 or more; Sepsis (confirmed or suspected infection treated with antibiotics for 5 days or more); Extra Corporal Membrane Oxygenation (ECMO); Renal replacement therapy; Use of vasopressor/inotropes; Nitric Oxygen treatment; On mechanical ventilation at 28 days of life	28 days
Secondary	Days alive without mechanical ventilation		28 days