Circulatory and Respiratory Physiological Phenomena, Infant, Premature, Diseases
Conditions
Keywords
Hemodynamic insuffiency, Low superior vena cava flow
Brief summary
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
Interventions
DRUGIntravenous dobutamine 5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.
DRUGIntravenous dobutamine 7.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.
DRUGIntravenous dobutamine 10 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.
DRUGIntravenous dobutamine 12.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.
DRUGIntravenous dobutamine 15 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NeoCirc-002 is a single center, dose finding trial to define the minimum effective dose of dobutamine to treat early hemodynamic insufficiency in the preterm infant (less than 33 completed weeks' gestation), defined as presence of low SVC flow (\<51 ml/k/min) within the first 72 hours from birth. The trial is a low-intervention clinical trial since dobutamine is the standard treatment for circulatory failure in preterm infants during transitional circulation, the dosages studied are within the standard therapeutic range, and the diagnostic supplementary procedures are in routine clinical practice.
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
Inclusion criteria
* Born with up to 32(+6) weeks gestation * Presence of hemodynamic insufficiency, defined as SVC flow \<51 ml/kg/min. * Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.
Exclusion criteria
* Neonates considered non-viable, with a clinical decision not to provide life support * Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment * Infants already on dobutamine treatment * Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects) * Infants with chromosomal anomalies * Lack of parental signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min | 1 and 3 hours | Short-term pharmacodynamics (PD) endpoint: Minimum dobutamine dose to reach and maintain a superior vena cava (SVC) flow above 55 ml/kg/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose. The effective start of the infusion (t0) will be calculated as the time at which the infusion pump is switched on plus the empirical value for the interval arising from the dead space. We summarize t0 as the time at which dobutamine is expected to reach the circulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status | 72 hours | Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth. Acceptable hemodynamic status is defined as the achievement and maintenance of dose success during the first 72 h from birth. The loss of such acceptable haemodynamic status occurs whenever there is a change in therapeutic strategy that involves cardiovascular treatment other than dobutamine alone due to exceeded safety parameters, treatment failure of the investigational infusion or the need for rescue treatment or death; any additional fluid bolus is considered as cardiovascular treatment. |
| Absolute and relative frequencies of adverse events and severe adverse events | Through study completion, an average of 12 months | Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups. AEs are defined as any untoward medical occurrence in a patient or clinical investigation patients administered a medicinal product, which does not necessarily have a causal relationship with this treatment (the study medication). SAEs are defined as any untoward medical occurrence that at any dose: * Results in death, * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect. * Other important medical events. |
Countries
Spain
Contacts
Primary ContactAdelina Pellicer, MD
Outcome results
None listed