Dobutamine in the Treatment of Haemodynamic Insufficiency in the Immediate Postnatal Period
NCT ID: NCT03311178
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2014-05-30
2017-10-10
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dobutamine
Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).
Dobutamine
Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).
Interventions
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Dobutamine
Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).
Eligibility Criteria
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Inclusion Criteria
* neonates 24 to 32+6 weeks´ gestation,
* postnatal age \<72 hours;
Infants eligible for circulatory failure pathway:
* parental informed consent obtained;
* The infants will be assessed, as per routine clinical practice, for clinical signs indicating infants at risk of poor perfusion, and will be recruited if they develop haemodynamic insufficiency defined as: either two or more of: (i) Mean blood pressure (MBP) \< gestational age (GA)-1 mmHg (invasive/non-invasive, two readings 15 min apart); (ii) SVC flow \< 51 ml/kg/min; (iii) capillary refill time (CRT) \> 4 sec; (iv) Lactate \> 4 mmol/l (v) Base excess \<-9 mmol/l or: MBP \< GA -5 mmHg (invasive/non-invasive, two readings 15 min apart)
Exclusion Criteria
* congenital hydrops or malformations likely to affect cardiovascular adaptation;
* surgery planned within 72 hours of birth;
* chromosomal anomalies;
* informed consent form (ICF) not signed.
72 Hours
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Brighton and Sussex University Hospitals NHS Trust
OTHER
University of Luebeck
OTHER
Servicio Vasco de Salud Osakidetza, Spain
UNKNOWN
University of Liverpool
OTHER
Vest Children´s Hospital, Germany
UNKNOWN
Datteln University Witten-Herdecke
UNKNOWN
Iuliu Hatieganu University of Medicine and Pharmacy
OTHER
Semmelweis University
OTHER
University of Pecs
OTHER
Gazi University
OTHER
Tufts Medical Center
OTHER
Hannover Medical School
OTHER
Onorach Clinical Dundee, Scotland
UNKNOWN
Proveca Limited Daresbury, England
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
OTHER
Responsible Party
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Adelina Pellicer
Chief Investigator
Principal Investigators
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Adelina Pellicer, MD PhD
Role: STUDY_CHAIR
SERMAS La Paz University Hospital
Heike Rabe, MD PhD
Role: STUDY_DIRECTOR
Brighton and Sussex University Hospitals (BSUH)
Fernando Cabañas, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio Madrileño de Salud (SERMAS)
Locations
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La Paz University Hospital, Department of Neonatology
Madrid, , Spain
Countries
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References
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Kluckow M, Evans N. Low superior vena cava flow and intraventricular haemorrhage in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F188-94. doi: 10.1136/fn.82.3.f188.
Kluckow M, Evans N. Superior vena cava flow in newborn infants: a novel marker of systemic blood flow. Arch Dis Child Fetal Neonatal Ed. 2000 May;82(3):F182-7. doi: 10.1136/fn.82.3.f182.
Osborn DA, Paradisis M, Evans N. The effect of inotropes on morbidity and mortality in preterm infants with low systemic or organ blood flow. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD005090. doi: 10.1002/14651858.CD005090.pub2.
Dempsey EM, Barrington KJ. Treating hypotension in the preterm infant: when and with what: a critical and systematic review. J Perinatol. 2007 Aug;27(8):469-78. doi: 10.1038/sj.jp.7211774.
Other Identifiers
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Neocirculation 001
Identifier Type: -
Identifier Source: org_study_id