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New treatment option for Infant, Premature, Diseases
Official title Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
ClinicalTrials.gov ID: NCT06878742
What this study is testing
What is Intravenous dobutamine 5 mcg/kg/min?
Intravenous dobutamine 5 mcg/kg/min is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for infant, premature, diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 72
You may be able to join 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 likely can't join 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...
- Infants with chromosomal anomalies
- Lack of parental signed informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 72 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.