Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period
Status:
Terminated
Trial end date:
2017-10-10
Target enrollment:
Participant gender:
Summary
Haemodynamic insufficiency after birth is seen commonly in babies born prematurely and is
associated with adverse outcomes. In current clinical practice, a combination of blood
pressure and clinical signs is used to guide therapy. However, blood pressure is a poor
surrogate of systemic and organ (brain) blood flow distribution during transitional
circulation. This state is characterised by increased peripheral vascular resistance and
increased afterload causing myocardial depression and impaired blood flow distribution in
spite of 'normal' blood pressure. Echocardiography-Doppler (Echo-D) measurement of superior
vena cava (SVC) flow has been proposed as a more clinically relevant marker of circulatory
impairment shortly after birth than systemic hypotension. When there is low SVC flow, several
small-scale clinical trials have suggested dobutamine as the optimal therapeutic option.
However the associations between SVC flow and short- and long- term outcomes are not strong
enough to allow SVC flow alone to be the basis for the inclusion of patients into a
confirmatory trial to demonstrate the efficacy and safety of dobutamine.
NeoCirc-001 - The primary objective is to answer some important questions required for the
design of a subsequent placebo-controlled trial (NeoCirc-003), which will evaluate the
effectiveness of a new neonatal formulation of dobutamine to treat haemodynamic insufficiency
in the first 72 hours after birth in babies born at less than 33 weeks' gestation.
Observational data will be collected from this population with a view to determining the
degree to which diagnostic measures influence treatment decisions. The primary outcome is
death or worst cranial ultrasound (CUS) appearance at or before 36 weeks' gestation.
NeoCirc-001A - The primary objective is to estimate the elimination half-life, and
consequently the time to steady-state of dobutamine in extremely premature neonates.
NeoCirc-001B - The primary objective is to construct a population pharmacokinetic
pharmacodynamic model that will be validated using samples collected during the confirmatory
trial (NeoCirc-003).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Collaborators:
Brighton and Sussex University Hospitals NHS Trust Datteln University Witten-Herdecke Gazi University Hannover Medical School Hospital Universitario La Paz Institut National de la Santé Et de la Recherche Médicale, France Iuliu Hatieganu University of Medicine and Pharmacy Onorach Clinical Dundee, Scotland Proveca Limited Daresbury, England Semmelweis University Servicio Vasco de Salud Osakidetza, Spain Tufts Medical Center University of Liverpool University of Luebeck University of Pecs Vest Children´s Hospital, Germany