Actively Recruiting
Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-03-17
30
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
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 1/2, 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 ml/kg/min 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours or until discontinuation by physician
Participants receive intravenous dobutamine at assigned doses. The infusion duration and weaning are determined by the attending physician according to local policies.
Continuous hospital monitoring during infusion
Duration - Up to 12 months
Participants are monitored for safety and adverse events through study completion.
Periodic follow-up visits as needed
Trial Site Locations
Total: 3 locations
1
Hospital Universitario Quironsalud
Madrid, Spain, 28002
Actively Recruiting
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
3
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Adelina Pellicer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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