MedTrace Logo

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

NCT06878742 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06878742 on ClinicalTrials.gov