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Dose-finding for dobutamine during transitional circulation in the very preterm infant
EU CTIS ID: 2023-504915-34-00
What this study is testing
To determine the minimum effective dose of dobutamine required to treat low SVC flow (<51 ml/k/min) in very preterm infants (short- term pharmacodynamic (PD) objective).
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Born up to 32(+6) weeks gestation
- Presence of haemodynamic 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 as described in section 5.4.
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 congenital heart defects).
- Infants carrying chromosomal anomalies
- Lack of parental signed informed consent
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.