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Clinical Trials/NCT01605279
NCT01605279CompletedPhase 2

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

Adelina Pellicer1 site in 1 country127 target enrollmentStarted: September 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
127
Locations
1
Primary Endpoint
Low SVCF prevalence

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
— to 12 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Dobutamine

Experimental

Patients with low SVCF in the first 12 hours of life will be randomised to receive dobutamine or placebo.

Intervention: Dobutamine (Drug)

Placebo

Placebo Comparator

Patients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Low SVCF prevalence

Time Frame: From birth to the 4th day of postnatal life

Low superior vena cava flow (SVCF) prevalence (\<40cc/kg/min ) assessed with echocardiography

Secondary Outcomes

  • Mortality and neurodevelopment variables(From birth until 2 years of corrected age)
  • Required dose for achieving SVCF-OP-60 (≥40 cc/kg/min maintained during 60 minutes)(From birth to the 4th day of postnatal life)
  • Doppler-cranial ultrasonography (PD-CUS) variables.(From birth to the 4th day of postnatal life)
  • Invasive or non-invasive arterial blood pressure(From birth to the 4th day of postnatal life)
  • Respiratory rate(From birth to the 4th day of postnatal life)
  • Other echocardiographic variables(From birth to the 4th day of postnatal life)
  • Biochemistry markers(From birth to the 4th day of postnatal life)
  • NIRS variables(From birth to 24 hours of life)
  • Heart rate(From birth to the 4th day of postnatal life)
  • Required dose for achieving SVCF-OP (≥40 cc/kg/min)(From birth to the 4th day of postnatal life)
  • Central and peripheral temperature(From birth to the 4th day of postnatal life)
  • Structural brain damage markers:(From birth to discharge (approximately around 10-15 weeks))

Investigators

Sponsor
Adelina Pellicer
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Adelina Pellicer

Principal investigator

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Study Sites (1)

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