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

University of Ulm

Status and phase: Unknown; Phase 4

Conditions: Arterial Hypotension

Treatments: Drug: Dopamine; Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01427686

ULMNEONIRS01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Dobutamine

Active Comparator group

Description:

Start Dobutamine. If no success switch to Dopamine.

Treatment:

Drug: Dobutamine

Dopamine

Active Comparator group

Description:

Start Dopamine. If no success switch to Dobutamine.

Treatment:

Drug: Dopamine