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
Completed
- Conditions
- cerebral hypoxiacerebral oxygenation1002930510028920
- Registration Number
- NL-OMON37782
- Lead Sponsor
- Region Hovestaden, Department of Neonatology 5024, Rigshospitalet
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
Inclusion Criteria
preterm, gestational age <28 weeks, inborn, egiligible for inclusion within 3 hours after birth
Exclusion Criteria
congenital malformation, outborn, postnatal age more than 3 hours, no informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the burden of hypo- and hyperoxia in %hours during the<br /><br>first 72 hours after birth. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcomes are brain activity on an amplitude-integrated<br /><br>electroencephalogram (aEEG), blood biomarkers (brain fatty acid binding protein<br /><br>(BFABP), neuroketal, and S100*), serious adverse reactions (SARs), severe brain<br /><br>injury, and all cause mortality at term date (approximately three months after<br /><br>birth). The exploratory outcomes are burden of hypoxia, burden of hyperoxia,<br /><br>neonatal morbidities, brain injury score on magnetic resonance imaging (MRI),<br /><br>number of therapies implemented during the intervention, physiological<br /><br>variables (mean blood pressure (BP), pulse oximeter oxygen saturation (SpO2),<br /><br>and partial pressure of carbon dioxide (pCO2)), and psychomotor impairment<br /><br>according to neurodevelopmental scales at 24 months after term equivalent age<br /><br>(BSIDIII)</p><br>