NCT06878742

Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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 weeks' gestation during transitional circulation (first 72 hours from birth).

Conditions

• Infant, Premature, Diseases
• Circulatory and Respiratory Physiological Phenomena

Interventions

Type	Name	Description
DRUG	Intravenous dobutamine 5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.
DRUG	Intravenous dobutamine 7.5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.
DRUG	Intravenous dobutamine 10 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.
DRUG	Intravenous dobutamine 12.5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.
DRUG	Intravenous dobutamine 15 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.

Timeline

• Start date: 2024-06-24
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

3 sites across 1 country: Spain