Effect of Dobutamine as Compared to Dopamine on Cerebral Oxygenation, Mean Arterial Pressure and Cerebral Hemodynamics in Term and Preterm Neonates With Arterial Hypotension
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cerebral tissue oxygen saturation
Study Overview
Brief Summary
The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.
The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 44 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •fluid refractory arterial hypotension
- •newborn infant below 44 weeks postmenstrual age
- •parental informed consent
Exclusion Criteria
- •preterm infant below 28 weeks postmenstrual age during the first week of life
- •congenital life-threatening malformations
- •decision for palliative care
- •hemorrhagic shock
- •other obvious cause for arterial hypotension that requires immediate specific treatment, e.g. tension pneumothorax
Arms & Interventions
Dobutamine
Start Dobutamine. If no success switch to Dopamine.
Intervention: Dobutamine (Drug)
Dopamine
Start Dopamine. If no success switch to Dobutamine.
Intervention: Dopamine (Drug)
Outcomes
Primary Outcomes
Cerebral tissue oxygen saturation
Time Frame: during study medication
Cerebral tissue oxygen saturation (and derived parameters FTOE, HbD and Total Hb as secondary outcomes) measured by near-infrared spectroscopy after achieving normal blood pressure
Secondary Outcomes
- Cardiac output(during study medication)
Investigators
Manuel Schmid
Dr. med.
University of Ulm