An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency in the immediate postnatal period

• Conditions: babies with evidence of haemodynamic insufficiency within 72 hours after birth; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-002845-12-HU
• Lead Sponsor: SERMAS (Hospital la Paz)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-17
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

-neonates 24 to 32+6 weeks´ gestation,
-postnatal age <72 hours;
-parental informed consent;
-clinical signs indicating infants at risk of poor perfusion (i.e. evidence of haemodynamic insufficiency) defined as:
-either two or more of:
(i) Mean blood pressure (MBP) < gestational age (GA)-1 mmHg (invasive/non-invasive, two readings 15 min apart);
(ii) SVC flow < 51 ml/kg/min;
(iii) CRT > 4 sec;
(iv) Lactate > 4 mmol/l
(v) Base excess <-9 mmol/l

-or: MBP < GA -5 mmHg (invasive/non-invasive, two readings 15 min apart)
Are the trial subjects under 18? yes
Number of subjects for this age range: 198
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 Number of subjects for this age range

Exclusion Criteria

NeoCirc-001 -
-non-viability;
-congenital hydrops or malformations likely to affect cardiovascular adaptation;
-surgery planned within 72 hours of birth;
-chromosomal anomalies;
-informed consent form (ICF) not signed.

Study & Design

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