Treatment of hypotension of prematurity: a non-blinded cohort clinical trial
Completed
- Conditions
- hypotensionlow blood pressure100422581002892010011954
- Registration Number
- NL-OMON34563
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Preterm infants with gestational age <30wks admitted to the neonatal intensive care developing mean bloodpressure < gestational age in weeks (current guideline) during the first 72 hours of life.
Exclusion Criteria
Prior to inclusion indirect clinical (capillary refill;urine production) or direct laboratory evidence (lactate) of poor organ/tissue perfusion, intra uterine exposure to excessive maternal vasoactive medication , severe clinically or microbiologically proven sepsis or congenital malformations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine whether refraining (group B) from anti-hypotensive treatment has a<br /><br>negative, positive or no effect on the composite outcome of mortality and<br /><br>neurodevelopmental outcome (determined by BSID-III) at 24 months of age. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures will include 1) differences between the groups in<br /><br>the incidence of PIVH during the first 7 postnatal days detected by head<br /><br>ultrasound, 2) differences in the incidence of white matter injury PVL and gray<br /><br>matter injury not detected within the first 7 days by ultrasound using advanced<br /><br>MRI parameters of the brain at the adjusted postmenstrual age of 40 weeks as<br /><br>well as the ability to maintain CBF autoregulation during the first three<br /><br>postnatal days.</p><br>