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

Launched by INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called dobutamine in very premature infants, specifically those born before 33 weeks of pregnancy. The goal is to find the smallest amount of dobutamine that can help improve blood flow in these infants during their first three days after birth, a critical time when their bodies are adjusting to life outside the womb. This study is currently looking for participants and aims to help doctors better manage the condition of low blood flow in these tiny patients.

To be eligible for the trial, infants must be born at 32 weeks of pregnancy or earlier and show signs of low blood flow, which is measured in a specific way. Parents or legal guardians will need to give their consent for their child to participate. It's important to note that some infants may not be eligible, such as those who are not expected to survive or have certain serious health conditions. If enrolled, participants will be closely monitored to ensure their safety throughout the study. This research could provide valuable information to support the health of premature infants in the future.

Gender

ALL

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:
• • 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