What is dobutamine studying for very preterm infants with low blood flow?

Dobutamine is being studied to find the smallest effective dose to improve blood flow in very preterm infants born before 33 weeks. This trial evaluates how different doses affect circulation during the first 72 hours after birth. The research is sponsored by Instituto de Investigación Hospital Universitario La Paz.

Who may be eligible for this very preterm infant clinical trial?

Eligible participants are babies born before 33 weeks of gestation with low superior vena cava blood flow under 51 ml/kg/min and less than 72 hours old. Babies with serious congenital malformations or those already on dobutamine treatment are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this very preterm infant clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Families can expect the study to cover treatments and assessments related to the trial.

Actively Recruiting

Phase 1

Phase 2

Age: 0 - 72Hours

All Genders

ID06878742

Finding the Lowest Effective Dose of Dobutamine to Treat Low Blood Flow in Very Preterm Infants During Their First 72 Hours

Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-03-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying very preterm infants born before 33 weeks of gestation to find the smallest effective dose of dobutamine needed to treat low blood flow in the superior vena cava during the first 72 hours after birth. This condition, called hemodynamic insufficiency, affects blood circulation in newborns during transitional circulation. The study is a phase 12, single-center dose-finding trial aiming to improve care for these vulnerable infants. Participants will receive intravenous dobutamine at one of five increasing doses 5, 7.5, 10, 12.5, or 15 micrograms per kilogram per minute. The attending physician will decide when to reduce or stop the infusion following local guidelines. Each dose group is studied to determine the minimum dobutamine dose that raises and maintains superior vena cava flow above 55 mlkgmin within 1 to 3 hours. During the study, researchers will monitor the infants blood flow and clinical status for up to 72 hours and track any adverse events for about 12 months on average. The primary measurement is the minimum dobutamine dose needed to maintain adequate blood flow. Secondary outcomes include how many infants achieve stable circulation and the frequency of any side effects. The study will help define safe and effective doses for treating this condition in very preterm babies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 72Hours

All Genders

Eligibility Criteria

You may qualify if you...

Born with up to 32(+6) weeks gestation
Presence of hemodynamic insufficiency, defined as superior vena cava flow less than 51 ml/kg/min
Signed informed consent by parent or legally designated representative, which can be given before birth

You will not qualify if you...

Neonates considered non-viable with a decision not to provide life support
Severe congenital hydrops fetalis requiring chest or peritoneal drainage before recruitment
Infants already receiving dobutamine treatment
Congenital malformations likely to affect cardiovascular adaptation, including diaphragmatic hernia, gastroschisis, or congenital heart defects
Chromosomal anomalies
Lack of signed parental informed consent

Research Team

Adelina Pellicer, MD

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