Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants (NeoCirc-002)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Drug: Intravenous dobutamine 12.5 mcg/kg/min; Drug: Intravenous dobutamine 5 mcg/kg/min; Drug: Intravenous dobutamine 15 mcg/kg/min; Drug: Intravenous dobutamine 10 mcg/kg/min; Drug: Intravenous dobutamine 7.5 mcg/kg/min

Study type: Interventional

Funder types: Other

Identifiers

NCT06878742

HULP 6422

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: Under 72 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Dobutamine dose A

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dobutamine 5 mcg/kg/min

Dobutamine dose B

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dobutamine 7.5 mcg/kg/min

Dobutamine dose C

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dobutamine 10 mcg/kg/min

Dobutamine dose D

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dobutamine 12.5 mcg/kg/min

Dobutamine dose E

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dobutamine 15 mcg/kg/min