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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dobutamine dose A | Experimental | 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. |
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| Dobutamine dose B | Experimental | 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. |
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| Dobutamine dose C | Experimental | 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. |
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| Dobutamine dose D | Experimental | 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. |
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| Dobutamine dose E | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous dobutamine 5 mcg/kg/min | Drug | Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 1 and 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adelina Pellicer, MD | Contact | 917277416 | adelina.pellicer@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Quironsalud | Recruiting | Madrid | 28002 | Spain |
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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.
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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.
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| Intravenous dobutamine 7.5 mcg/kg/min | Drug | Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. |
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| Intravenous dobutamine 10 mcg/kg/min | Drug | Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. |
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| Intravenous dobutamine 12.5 mcg/kg/min | Drug | Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. |
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| Intravenous dobutamine 15 mcg/kg/min | Drug | Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min. |
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| 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:
| Through study completion, an average of 12 months |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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