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

Phase 1

Recruiting

• Conditions: Infant, Premature, Diseases; Circulatory and Respiratory Physiological Phenomena
• Interventions: Drug: 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

• Registration Number: NCT06878742
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Study First Submitted: 2024-12-02
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dobutamine dose A	Intravenous dobutamine 5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Dobutamine dose B	Intravenous dobutamine 7.5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Dobutamine dose C	Intravenous dobutamine 10 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Dobutamine dose D	Intravenous dobutamine 12.5 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.
Dobutamine dose E	Intravenous dobutamine 15 mcg/kg/min	Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min. Weaning and stopping of the dobutamine infusion will be determined by the attending physician, following local policies.

Primary Outcome Measures

Name	Time	Method
Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min	1 and 3 hours	Short-term pharmacodynamics (PD) endpoint: Minimum dobutamine dose to reach and maintain a superior vena cava (SVC) flow above 55 ml/kg/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose.; The effective start of the infusion (t0) will be calculated as the time at which the infusion pump is switched on plus the empirical value for the interval arising from the dead space. We summarize t0 as "the time at which dobutamine is expected to reach the circulation"

Secondary Outcome Measures

Name	Time	Method
Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status	72 hours	Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth.; Acceptable hemodynamic status is defined as the achievement and maintenance of dose success during the first 72 h from birth. The loss of such acceptable haemodynamic status occurs whenever there is a change in therapeutic strategy that involves cardiovascular treatment other than dobutamine alone due to exceeded safety parameters, treatment failure of the investigational infusion or the need for rescue treatment or death; any additional fluid bolus is considered as cardiovascular treatment.
Absolute and relative frequencies of adverse events and severe adverse events	Through study completion, an average of 12 months	Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups.; AEs are defined as any untoward medical occurrence in a patient or clinical investigation patients administered a medicinal product, which does not necessarily have a causal relationship with this treatment (the study medication).; SAEs are defined as any untoward medical occurrence that at any dose: * Results in death,; * Is life-threatening; * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity, or; * Is a congenital anomaly/birth defect.; * Other important medical events.

Trial Locations

Locations (3)

Hospital Universitario Quironsalud; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain