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Hemodynamic InstabilityPhase 2NCT01605279

Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

A Phase 2 study testing Dobutamine in people with Hemodynamic Instability, run by Adelina Pellicer at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 12 hours
Conditions the study is for
Hemodynamic Instability
What is being tested?
Dobutamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
1 siteSpain
Study dates
Sep 2010to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • La Paz University Hospital

    Madrid, Madrid, 28046

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Dobutamine, Placebo
Keywords
Low superior vena cava flow, Functional echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DobutamineDrug

    Also called DB

    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.

  • PlaceboDrug

    Also called PL

    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)

Study groups in NCT01605279
Study groupRoleWhat they receive
DobutamineExperimentalPatients with low SVCF in the first 12 hours of life will be randomised to receive dobutamine or placebo.
Receives: Drug: Dobutamine
PlaceboPlacebo comparatorPatients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Low SVCF prevalence

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

    Measured: From birth to the 4th day of postnatal life

Secondary outcomes (12)

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

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

    Measured: From birth to the 4th day of postnatal life

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

    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

    Measured: From birth to the 4th day of postnatal life

  3. NIRS variables

    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.

    Measured: From birth to 24 hours of life

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

    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.

    Measured: From birth to the 4th day of postnatal life

  5. Invasive or non-invasive arterial blood pressure

    Invasive or non-invasive arterial blood pressure

    Measured: From birth to the 4th day of postnatal life

  6. Central and peripheral temperature

    Central and peripheral temperature

    Measured: From birth to the 4th day of postnatal life

  7. Heart rate

    Heart rate

    Measured: From birth to the 4th day of postnatal life

  8. Respiratory rate

    Respiratory rate

    Measured: From birth to the 4th day of postnatal life

  9. Other echocardiographic variables

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

    Measured: From birth to the 4th day of postnatal life

  10. Biochemistry markers

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

    Measured: From birth to the 4th day of postnatal life

  11. Structural brain damage markers:

    • 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.

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

  12. Mortality and neurodevelopment variables

    • Mortality rate
    • Cerebral palsy
    • Neurodevelopmental delay

    Measured: From birth until 2 years of corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605279
Sponsor's protocol ID
NeoDobuta
Other IDs
2009-010901-35, 2009
Status last verified
Mar 2015
First submitted
22 May 2012
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1542/peds.2006-3398.

    PubMed 17671064

  • Bravo MC, Lopez-Ortego P, Sanchez L, Riera J, Madero R, Cabanas F, Pellicer A. Randomized, Placebo-Controlled Trial of Dobutamine for Low Superior Vena Cava Flow in Infants. J Pediatr. 2015 Sep;167(3):572-8.e1-2. doi: 10.1016/j.jpeds.2015.05.037. Epub 2015 Jun 24.

    PubMed 26116470

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dobutamine in people with Hemodynamic Instability, run by Adelina Pellicer at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low SVCF prevalence (time frame: From birth to the 4th day of postnatal life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605279, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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