Finding the right dose of dobutamine for very preterm infants with low blood flow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine the minimum effective dose of dobutamine needed to treat hemodynamic insufficiency in very preterm infants born at or below 32 weeks of gestation during their first 72 hours after birth. The study will administer varying doses of intravenous dobutamine to assess their effectiveness in improving blood flow, specifically targeting low superior vena cava flow. The trial is conducted at a single center, focusing on a vulnerable population of premature infants who may experience significant circulatory challenges.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Universitario Quironsalud
  Madrid, Spain Recruiting
• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting
• Hospital Universitario La Paz
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Adelina Pellicer, MD
• Email: adelina.pellicer@salud.madrid.org
• Phone: 917277416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.