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Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

Information source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemodynamic Instability

Intervention: Dobutamine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Adelina Pellicer

Official(s) and/or principal investigator(s):
María Carmen Bravo, PhDMD, Principal Investigator, Affiliation: Fundación Investigación Biomédica HULP

Summary

Low systemic flow as measured by Doppler-echocardiography has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low systemic flow in preterm infants with dobutamine has any effect on the cerebral circulation and in newborn prognosis.

Clinical Details

Official title: Randomised Double Blind Clinical Trial of Dobutamine Versus Placebo for Low Superior Vena Cava Flow Treatment in Low Birth Weight Infants: Systematic Assessment of Cerebral and Systemic Hemodynamics Effects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Low SVCF prevalence

Secondary outcome:

Required dose for achieving SVCF-OP (≥40 cc/kg/min)

Required dose for achieving SVCF-OP-60 (≥40 cc/kg/min maintained during 60 minutes)

NIRS variables

Doppler-cranial ultrasonography (PD-CUS) variables.

Invasive or non-invasive arterial blood pressure

Central and peripheral temperature

Heart rate

Respiratory rate

Other echocardiographic variables

Biochemistry markers

Structural brain damage markers:

Mortality and neurodevelopment variables

Detailed description: While rates of survival for very preterm infants are increasing, a significant number of these patients suffer from neurodevelopmental disabilities. The pathophysiology of brain injury in the preterm infant is unclear, although haemodynamic disturbances during the period of transitional circulation after birth leading to ischemia-reperfusion events seem to play an important role. Up to one third of infants born under 30 weeks of gestation develop low systemic flow as measured by Doppler-echocardiography (low superior vena cava flow, SVCF); this finding has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this hemodynamic condition is beneficial or not. This study aims to evaluate if treating low systemic flow in preterm infants with dobutamina, DB, (inotrope-sympathicomimetic drug) has any effect on the cerebral circulation; specific interest of our research would be to target DB dose for individual patient´s response. Secondly, by means of two non-invasive technologies (cerebral and cardiac ultrasonography-Doppler and near infrared spectroscopy, NIRS), the investigators search to characterise eventual differences in brain perfusion patterns during the adaptation to the transitional circulation that might be associated with the development of brain injury in the most vulnerable population.

Eligibility

Minimum age: N/A. Maximum age: 12 Hours. Gender(s): Both.

Criteria:

Inclusion criteria

- Newborn infants born at ≤ 28 weeks of gestational age.

- Newborn infants born at > 28 weeks of gestational age and ≤ 30 weeks of gestational

age with moderate-severe respiratory distress syndrome, defined as the necessity of respiratory support with a mean pressure ≥ 4 cm H2O or FiO2 ≥ 0. 3

- Admission at the NICU in the first 6 hours of life

- Inotrope treatment absent

- Inform consent signed

Exclusion criteria

- Early systemic hypotension, defined as a mean arterial pressure (MAP) lower than the

gestational age, during at least 60 minutes and maintained after volume infusion

- Major congenital malformation

- Informed consent declined

Locations and Contacts

La Paz University Hospital, Madrid 28046, Spain
Additional Information

Related publications:

Osborn DA, Evans N, Kluckow M, Bowen JR, Rieger I. Low superior vena cava flow and effect of inotropes on neurodevelopment to 3 years in preterm infants. Pediatrics. 2007 Aug;120(2):372-80.

Starting date: September 2010
Last updated: March 6, 2015

Page last updated: August 20, 2015

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