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

NCT06878742 | Recruiting Phase 1

• 1 other identifier: HULP 6422
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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).

Conditions

Infant, Premature, Diseases; Circulatory and Respiratory Physiological Phenomena

Keywords

Hemodynamic insuffiency; Low superior vena cava flow

Outcome Measures

Primary Outcomes (1)

• Minimum dobutamine dose to reach and maintain a SVC flow above 55 ml/kg/min

  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"

  1 and 3 hours

Secondary Outcomes (2)

• Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status

  72 hours

• Absolute and relative frequencies of adverse events and severe adverse events

  Through study completion, an average of 12 months

Study Arms (5)

Dobutamine dose A

EXPERIMENTAL

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.

Drug: Intravenous dobutamine 5 mcg/kg/min

Dobutamine dose B

EXPERIMENTAL

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.

Drug: Intravenous dobutamine 7.5 mcg/kg/min

Dobutamine dose C

EXPERIMENTAL

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.

Drug: Intravenous dobutamine 10 mcg/kg/min

Dobutamine dose D

EXPERIMENTAL

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.

Drug: Intravenous dobutamine 12.5 mcg/kg/min

Dobutamine dose E

EXPERIMENTAL

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.

Drug: Intravenous dobutamine 15 mcg/kg/min

Interventions

Intravenous dobutamine 5 mcg/kg/min DRUG

Intravenous dobutamine will be administered at a dose of 5 mcg/kg/min.

Dobutamine dose A

Intravenous dobutamine 7.5 mcg/kg/min DRUG

Intravenous dobutamine will be administered at a dose of 7.5 mcg/kg/min.

Dobutamine dose B

Intravenous dobutamine 10 mcg/kg/min DRUG

Intravenous dobutamine will be administered at a dose of 10 mcg/kg/min.

Dobutamine dose C

Intravenous dobutamine 12.5 mcg/kg/min DRUG

Intravenous dobutamine will be administered at a dose of 12.5 mcg/kg/min.

Dobutamine dose D

Intravenous dobutamine 15 mcg/kg/min DRUG

Intravenous dobutamine will be administered at a dose of 15 mcg/kg/min.

Dobutamine dose E

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (3)

Hospital Universitario Quironsalud

Madrid, 28002, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Adelina Pellicer, MD

CONTACT

917277416; adelina.pellicer@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: NeoCirc-002 is a single center, dose finding trial to define the minimum effective dose of dobutamine to treat early hemodynamic insufficiency in the preterm infant (less than 33 completed weeks' gestation), defined as presence of low SVC flow (\<51 ml/k/min) within the first 72 hours from birth. The trial is a low-intervention clinical trial since dobutamine is the standard treatment for circulatory failure in preterm infants during transitional circulation, the dosages studied are within the standard therapeutic range, and the diagnostic supplementary procedures are in routine clinical practice.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: March 17, 2025
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)