A Phase 1/2 interventional study of Intravenous dobutamine 5 mcg/kg/min and Intravenous dobutamine 7.5 mcg/kg/min in Infant, Premature, Diseases and Circulatory and Respiratory Physiological Phenomena, sponsored by Instituto de Investigación Hospital Universitario La Paz. Recruiting at 3 sites in Spain. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 1/2, Interventional, and Treatment
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).
100 studies on the registry are indexed under Infant, Premature, Diseases; 16 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 64 interventional studies indexed under Infant, Premature, Diseases.
Browse Infant, Premature, Diseases studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Drug: Intravenous dobutamine 5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Drug: Intravenous dobutamine 7.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Drug: Intravenous dobutamine 10 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Drug: Intravenous dobutamine 12.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Drug: Intravenous dobutamine 15 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min
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"
Time frame: 1 and 3 hours
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status
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.
Time frame: 72 hours
Absolute and relative frequencies of adverse events and severe adverse events
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.
Time frame: Through study completion, an average of 12 months
Plan to share: No
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Instituto de Investigación Hospital Universitario La Paz