Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Dobutamine as Compared to Dopamine on Cerebral Oxygenation, Mean Arterial Pressure and Cerebral Hemodynamics in Term and Preterm Neonates With Arterial Hypotension

Conditions
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Arterial Hypotension

Intervention / Treatment
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* Drug: Dobutamine
* Drug: Dopamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dobutamine<br>Start Dobutamine. If no success switch to Dopamine. | Drug: Dobutamine<br>* Start Dobutamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dopamine.<br>|
| Active Comparator: Dopamine<br>Start Dopamine. If no success switch to Dobutamine. | Drug: Dopamine<br>* Start Dopamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dobutamine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygen saturation | 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 | during study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry | during treatment | 
| Cardiac output | Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry | during study medication |