TREATMENT OF HYPOTENSION IN EXTREMELY PRETERM INFANTS: A MULTICENTER RANDOMIZED CONTROLLED TRIAL - ND
- Conditions
- HYPOTENSION IN EXTREMELY PRETERM INFANTSMedDRA version: 9.1Level: LLTClassification code 10049223
- Registration Number
- EUCTR2009-016653-17-IT
- Lead Sponsor
- AZIENDA UNITA` SANITARIA LOCALE N 12 DI VIAREGGIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
premature neonates 23-30 weeks gestation that present hypotension (BP < threshold for at least 10 minutes), and whose parents have given an informed consent to the study. The BP threshold for inclusion is based on GA (Attachment 1).
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Congenital heart diseases (except patent ductus arteriosus) identified by echocardiography; Severe /lethal congenital anomalies; Massive hemorrhage; neonates only offered supportive/palliative care; hypotension occurring > 3 days of life
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method