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Completed

NCT Number: NCT01605279

Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

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.

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Key information

Conditions

Hemodynamic Instability

Age range

Up to 12 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

La Paz University Hospital

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dobutamine

Drug

Patients with low SVCF in the first 12 hours of life will be randomized to receive Dobutamine or Placebo. First dose: 5 microg/k/min; second dose: 10 microg/k/min; third dose: 15 microg/k/min; forth dose: 20 microg/k/min. Dobutamine concentration will be prepared in a 20 ml syringe and the dose will be adjusted so each 0.1 ml/kg per hour increase in flow rate would deliver the corresponding step-increase in the drug infusion dose. Dose increments will be 5, 10, 15, 20 microg/kg per minute The study drug was increased in a stepwise manner every 30 minutes until the optimal SVCF was attained and maintained for 60 minutes (SVCF-OP). Treatment duration: 24 hours of postnatal age, maintaining the infusion rate which achieves the SVCF-OP.

Other names: DB

Placebo

Drug

Patients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo (dextrose 5% in water, D5W, as Placebo)

Other names: PL

Primary outcomes

  1. 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

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

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

    Required dose of dobutamine for achieving superior vena cava flow optimum (SVCF-OP) that is SVCF ≥40 cc/kg/min

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

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

    Required dose of dobutamine for achieving superior vena cava flow optimum for 60 min (SVCF-OP-60), that is SVCF ≥40 cc/kg/min maintained during 60 minutes

  3. NIRS variables

    Time frame: From birth to 24 hours of life

    NIRS variables: TOI (tissue oxygenation index), ∆HbT (as a marker of changes in cerebral blood volume, ΔDHb (as a marker of changes in cerebral blood flow will be monitored continuously by NIRS.

  4. Doppler-cranial ultrasonography (PD-CUS) variables.

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

    Doppler-cranial ultrasonography (PD-CUS) variables. Changes in cerebral blood flow velocities and the resistance index in cerebral arteries will be evaluated. The effect of SVCF changes on these variables will be analysed.

  5. Invasive or non-invasive arterial blood pressure

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

    Invasive or non-invasive arterial blood pressure

  6. Central and peripheral temperature

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

    Central and peripheral temperature

  7. Heart rate

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

    Heart rate

  8. Respiratory rate

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

    Respiratory rate

  9. Other echocardiographic variables

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

    • Right and left ventricular output
    • Pulmonary pressure
    • Patent ductus arteriosus

  10. Biochemistry markers

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

    • Arterial, venous or capillary gasometry, serum lactate
    • Hemogram, ions, glycemia, creatinine, proteins, Troponine I, N-terminal probrain natriuretic peptide(NT-proBNP)

  11. Structural brain damage markers:

    Time frame: From birth to discharge (approximately around 10-15 weeks)

    • Intraventricular hemorrhage (IVH) grade 1.
    • IVH grade 2.
    • IVH grade 3.
    • Periventricular hemorrhagic infarction.
    • Moderate or severe periventricular echogenicity.
    • Persistent periventricular echogenicity.
    • Cyst periventricular echogenicity.

  12. Mortality and neurodevelopment variables

    Time frame: From birth until 2 years of corrected age

    • Mortality rate
    • Cerebral palsy
    • Neurodevelopmental delay

Sponsors and collaborators

Lead sponsor

Adelina Pellicer

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 24, 2012
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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