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

I

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)

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

Trial contacts and locations

3

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Central trial contact

Adelina Pellicer, MD

Data sourced from clinicaltrials.gov

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