Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Recruiting
Phase 1
Phase 2
Interventional Study
Infant, Premature, Diseases
Circulatory and Respiratory Physiological Phenomena
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 72 Hours
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
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:…
Contacts