Dose-finding for dobutamine during transitional circulation in the very preterm infant

Phase 1

Conditions: eonates with haemodynamic insufficiency
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: CTIS2023-504915-34-00

Lead Sponsor: Hospital Universitario La Paz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

Born up to 32(+6) weeks gestation, Presence of haemodynamic 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 as described in section 5.4.

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 carrying chromosomal anomalies, Lack of parental signed informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the minimum effective dose of dobutamine required to treat low SVC flow (<51 ml/k/min) in very preterm infants (short- term pharmacodynamic (PD) objective).;Secondary Objective: To assess the proportion of infants who maintain an acceptable haemodynamic status with the dobutamine infusion alone in the first 72h from birth (efficacy), To evaluate the safety of dobutamine for the whole study population as well as for the seven treatment groups separately, To determine the individual variables that explain the interindividual pharmacokinetic (PK)/PD variability.;Primary end point(s): Short-term PD endpoint: Minimum dobutamine dose to reach and maintain an SVC flow above 55 ml/k/min on an echocardiogram performed at 1 and 3 hours after effective infusion of the allocated dose [A].

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status [B] with the dobutamine infusion alone in the first 72 hours from birth.;Secondary end point(s):Absolute and relative frequencies of adverse events (AEs) and severe adverse events (SAEs), to be recorded and compared between groups;Secondary end point(s):To determine the correlation between PK and PD.