Finding the right dose of dobutamine for very preterm infants with low blood flow
Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
This study is testing the right amount of dobutamine to help very premature babies with low blood flow during their first few days after birth.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 72 Hours |
| Sex | All |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz Academic / other |
| Locations | 3 sites (Madrid and 2 other locations) |
| Trial ID | NCT06878742 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at or below 32 weeks of gestation who exhibit signs of hemodynamic insufficiency.
Not a fit: Patients who are considered non-viable or have severe congenital conditions that affect cardiovascular adaptation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored treatment approach for very preterm infants suffering from low blood flow, potentially improving their survival and health outcomes.
How similar studies have performed: While this approach is focused on a specific population, similar studies targeting hemodynamic insufficiency in preterm infants have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.