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

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 - SafeBoosC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37782

Enrollment

Registered

2012-11-06

Start date

2013-03-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral hypoxia

Interventions

The premature infants will be randomised into one of two groups (experimental or control). Common is that both groups will have a cerebral oximeter monitoring device placed within three hours after

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: preterm, gestational age

Exclusion criteria

Exclusion criteria: congenital malformation, outborn, postnatal age more than 3 hours, no informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is the burden of hypo- and hyperoxia in %hours during the first 72 hours after birth.	—

Secondary

Measure	Time frame
The secondary outcomes are brain activity on an amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding protein (BFABP), neuroketal, and S100*), serious adverse reactions (SARs), severe brain injury, and all cause mortality at term date (approximately three months after birth). The exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain injury score on magnetic resonance imaging (MRI), number of therapies implemented during the intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment according to neurodevelopmental scales at 24 months after term equivalent age (BSIDIII)	—

Measure

Time frame

The secondary outcomes are brain activity on an amplitude-integrated electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding protein (BFABP), neuroketal, and S100*), serious adverse reactions (SARs), severe brain injury, and all cause mortality at term date (approximately three months after birth). The exploratory outcomes are burden of hypoxia, burden of hyperoxia, neonatal morbidities, brain injury score on magnetic resonance imaging (MRI), number of therapies implemented during the intervention, physiological variables (mean blood pressure (BP), pulse oximeter oxygen saturation (SpO2), and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment according to neurodevelopmental scales at 24 months after term equivalent age (BSIDIII)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)