An international study to investigate the effectiveness of dobutamine in supporting the hearts of premature babies soon after birth.

Phase 1

• Conditions: Haemodynamic insufficiency (Haemodynamic insufficiency after birth is commonly seen in babies born prematurely. The condition has a significant clinical impact. A final common pathway is seen but the consequences of functional impairment are diverse. During the neonatal period haemodynamic insufficiency can lead to loss of existing function and the loss of function that is yet to be developed.); MedDRA version: 20.0Level: PTClassification code 10009196Term: Circulatory failure neonatalSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002875-25-ES
• Lead Sponsor: SERMAS-FIBHULP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-25
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Infants are eligible to be included in the study only if they meet all of the following criteria:
•24(+0) to 32(+6) weeks gestation
•Admitted in the neonatal intensive care unit
•Presence of haemodynamic insufficiency, defined as the presence of one or more of the following within first 72 hours after birth:
oMABP < GA-1 (two readings, 15min apart) OR
oLactate > 4 mm/l OR
oSVC flow <51 ml/kg/min
•Provision of signed and dated informed consent form by patient’s parent/mother or legally designated representative; which can be given antenatally as described in section 5.4.
Three notes of caution are necessary with respect to inclusion of infants into this trial:
•The treating physician needs to be at clinical” equipoise on providing the proposed trial of dobutamine-treatment or placebo to the infant; which can be justified as explained in section 2.1 above.
•To avoid over treatment, the treating physician needs to fully understand the determinant of the pathophysiology of circulatory impairment and use clinical judgment to decide treatment. For example during severe congenital anaemia a baby meeting the inclusion criteria will not be included and will instead get the required blood volume replacement first; and only afterwards could be considered for inclusion if still eligible.
•Deferred informed consent is plausible in this condition because it is in accord with Article 35 of the Regulation of the European Union on Clinical Trials (Regulations (EU) no536/2014), that states: Informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the trial, provided that this decision is taken at the time of the first intervention on the subject, in accordance with the protocol for that clinical trial and that all the following conditions are fulfilled:
oUrgency of the situation, caused by a sudden life-threatening or other serious medical condition
oScientific grounds to expect that participation of the subject in the trial will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement or in the diagnosis of its condition
oIt is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his/her legally designated representative
oThe investigator certifies that he or she is not aware of any objections to participate in the clinical trial previously expressed by the legally designated representative
oThe clinical trial relates directly to the subject’s medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the legally designated representative and to supply prior information, and the clinical trial is such a nature that it may be conducted exclusively in emergency situations
oThe clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the condition.
Informed consent shall be sought to continue the participation of the subject in the clinical trial, and information on the clinical trial shall be given to the parent or the legally designated representative.
Are the trial subjects under 18? yes
Number of subjects for this age range: 270
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following 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 commercial dobutamine treatment
•Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects).
•Infants in whom a surgical treatment is planned within 72 hours of birth
•Infants carrying chromosomal anomalies
•Lack of parental signed informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified