Brain Autoregulation Research Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-30
SponsorBradley Marino
About this trial
Randomized, multi-site, study assessing the feasibility of lower limit of autoregulation targeted mean arterial pressure (MAP) vs. standard MAP management in neonates undergoing cardiac surgery with cardiopulmonary bypass. After eligibility screening and consent, subjects will be randomized to either the intervention (study) or control group.
Eligibility criteria
Qualifiers
All neonates (<30 days of age)
Undergoing cardiothoracic surgery with cardiopulmonary bypass
Disqualifiers
Less than full term (<37 weeks gestation)
Weight < 2.50kg
Genetic abnormality or syndrome except heterotaxy syndrome
Major non-cardiac anomalies (e.g. congenital diaphragmatic hernia, - omphalocele, holoprosencephaly, anencephaly)
Trial design
Treatments tested in this trial
- Surgery with Active MAP Management
- Surgery without Active MAP Management
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bradley Marino
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov