Status:
RECRUITING
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Infant, Premature, Diseases
Circulatory and Respiratory Physiological Phenomena
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE1
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06878742
Start Date
June 24 2024
End Date
June 1 2029
Last Update
March 17 2025
Active Locations (3)
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1
Hospital Universitario Quironsalud
Madrid, Spain, 28002
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
3
Hospital Universitario La Paz
Madrid, Spain, 28046