Recruiting NCT06878742
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min, Intravenous dobutamine 12.5 mcg/kg/min.
- Who it may be relevant to
- Registry conditions: Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena. Basic parameters: up to 72 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dose-finding for Dobutamine During Transitional Circulation in the Very Preterm Infant
Overview
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).
Interventions
- Drug Intravenous dobutamine 5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. - Drug Intravenous dobutamine 7.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. - Drug Intravenous dobutamine 10 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. - Drug Intravenous dobutamine 12.5 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. - Drug Intravenous dobutamine 15 mcg/kg/min
Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.
Primary outcome measures
- Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min [Time frame: 1 and 3 hours]
Secondary outcome measures (2)
- Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status [Time frame: 72 hours]
- Absolute and relative frequencies of adverse events and severe adverse events [Time frame: Through study completion, an average of 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 3 centers
- Hospital Universitario Quironsalud — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario La Paz — Madrid
Identifiers
NCT: NCT06878742 · HULP 6422