hypotension low blood pressure
Conditions
Interventions
Patients randomized to *Group A* will be treated for hypotension according to
the treatment protocol operative in the NICU at the UMCU. Patients randomized
to *Group B* will receive no cardiovascula
and/or urine output
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Preterm infants with gestational age
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether refraining (group B) from anti-hypotensive treatment has a negative, positive or no effect on the composite outcome of mortality and neurodevelopmental outcome (determined by BSID-III) at 24 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include 1) differences between the groups in the incidence of PIVH during the first 7 postnatal days detected by head ultrasound, 2) differences in the incidence of white matter injury PVL and gray matter injury not detected within the first 7 days by ultrasound using advanced MRI parameters of the brain at the adjusted postmenstrual age of 40 weeks as well as the ability to maintain CBF autoregulation during the first three postnatal days. | — |
Countries
Netherlands
Outcome results
None listed