Neonates with haemodynamic insufficiency
Conditions
Brief summary
Short-term PD endpoint: Minimum dobutamine dose to reach and maintain an SVC flow above 55 ml/k/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose [A].
Detailed description
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status [B] with the dobutamine infusion alone in the first 72 hours from birth., Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups, To determine the correlation between PK and PD.
Interventions
DRUGDobutamine Generis 12.5 mg/mL Solution for Infusion
Sponsors
Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short-term PD endpoint: Minimum dobutamine dose to reach and maintain an SVC flow above 55 ml/k/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose [A]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status [B] with the dobutamine infusion alone in the first 72 hours from birth., Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups, To determine the correlation between PK and PD. | — |
Countries
Spain
Outcome results
None listed