Actively Recruiting

Phase 1
Phase 2
Age: 0 - 72Hours
All Genders
NCT06878742

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

Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-03-17

30

Participants Needed

3

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 72Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born with up to 32(+6) weeks gestation
  • Presence of hemodynamic insufficiency, defined as SVC flow <51 ml/kg/min
  • Signed and dated informed consent form provided by a parent or legally designated representative, which can be given before birth
Not Eligible

You will not qualify if you...

  • Neonates considered non-viable with a decision not to provide life support
  • Infants with severe congenital hydrops fetalis requiring chest or peritoneal drainage before recruitment
  • Infants already receiving 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 signed parental informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital Universitario Quironsalud

Madrid, Spain, 28002

Actively Recruiting

2

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

3

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

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Research Team

A

Adelina Pellicer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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