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RECRUITINGPHASE1/PHASE2

Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant

NCT06878742•Instituto de Investigación Hospital Universitario La Paz

Summary

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).

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

Locations (3)

Hospital Universitario Quironsalud

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Key Dates

Start Date

June 24, 2024

Primary Completion Date

June 1, 2029

Completion Date

June 1, 2029

Last Updated

March 17, 2025

Enrollment

ESTIMATED participants

Conditions

Infant, Premature, DiseasesCirculatory and Respiratory Physiological Phenomena

Interventions

Intravenous dobutamine 5 mcg/kg/min

DRUG

Intravenous dobutamine 7.5 mcg/kg/min

DRUG

Intravenous dobutamine 10 mcg/kg/min

DRUG

Intravenous dobutamine 12.5 mcg/kg/min

DRUG

Intravenous dobutamine 15 mcg/kg/min

DRUG

Contacts

Adelina Pellicer, MD

CONTACT

917277416 adelina.pellicer@salud.madrid.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Inclusion Criteria

Exclusion Criteria

Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

Pain Assessment During Less-Invasive-Surfactant-Administration

Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

Optical Detection Infiltration/Extravasation in Neonates (ODINE)