Management of Hypotension In the Extremely Preterm Infant
- Conditions
- ow Blood PressureMedDRA version: 17.1Level: LLTClassification code 10024895Term: Low blood pressureSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-023988-17-CZ
- Lead Sponsor
- BrepCo Biopharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 830
•Gestational age from 23 weeks at birth to less than 28 completed weeks (i.e. up to and including 27 weeks and 6 days).
•Within 72 hours of birth.
•An indwelling arterial line, suitably calibrated and zeroed, to monitor blood pressure.
•A pre-trial cranial ultrasound scan free of grade III-IV IVH or cystic PVL.
•A mean blood pressure (BP) 1 mmHg or more below a mean BP value equivalent to the GA in completed weeks, which persists over a 15 minute period.
Are the trial subjects under 18? yes
Number of subjects for this age range: 830
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
•Infant is considered non-viable by attending clinicians.
•Life-threatening congenital abnormalities including congenital heart disease and chromosomal abnormalities.
•Infants known to require surgical treatment.
•Hydrops Fetalis.
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