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

Last updated: March 10, 2025
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Intravenous dobutamine 12.5 mcg/kg/min

Intravenous dobutamine 10 mcg/kg/min

Intravenous dobutamine 7.5 mcg/kg/min

Clinical Study ID

NCT06878742
HULP 6422
  • Ages < 72
  • All Genders

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).

Eligibility Criteria

Inclusion

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 legallydesignated representative, which can be given antenatally.

Exclusion

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 drainagebefore recruitment

  • Infants already on dobutamine treatment

  • Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heartdefects)

  • Infants with chromosomal anomalies

  • Lack of parental signed informed consent

Study Design

Total Participants: 30
Treatment Group(s): 5
Primary Treatment: Intravenous dobutamine 12.5 mcg/kg/min
Phase: 1/2
Study Start date:
June 24, 2024
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud

    Madrid, 28002
    Spain

    Active - Recruiting

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