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

Recruiting now · Phase 1/Phase 2

Conditions studied: Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena

In brief

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).

Key facts

Study ID

NCT06878742

Run by

Instituto de Investigación Hospital Universitario La Paz

People needed

30

Starts

2024-06-24

Expected to finish

2029-06-01

Last updated by the study team

2025-03-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Hospital Universitario Quironsalud — Madrid, Spain (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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