Management of Hypotension In the Extremely Preterm Infant
- Conditions
- ow Blood PressureMedDRA version: 20.0 Level: LLT Classification code 10024895 Term: Low blood pressure System Organ Class: 100000004866Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2010-023988-17-GB
- Lead Sponsor
- BrepCo Biopharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 340
•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 with the measuring dome at the level of the mid axillary
line when supine.
•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: 340
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 (excluding patent ductus arteriosus) and chromosomal
abnormalities. Infants known to require surgical treatment e.g.
congenital diaphragmatic hernia, tracheoesophageal fistula, omphalocele, gastroschisis. Hydrops Fetalis.
•Parenchymal haemorrhage or a grade III IVH (where over 50% of the ventricle is filled with blood).
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