Status:
TERMINATED
Management of Hypotension In the Preterm Infant
Lead Sponsor:
University College Cork
Collaborating Sponsors:
Cork University Hospital
Coombe Women and Infants University Hospital
Conditions:
Hypotension
Low Blood Pressure
Eligibility:
All Genders
23-27 years
Phase:
PHASE3
Brief Summary
The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in extremely low gestational age newborns (Standard with dopamine vers...
Detailed Description
While hypotension - low blood pressure (BP) - is commonly diagnosed and treated in the very preterm infant there is enormous variation in clinical practice.Hypotension is statistically associated with...
Eligibility Criteria
Inclusion
- Gestational age at birth 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, either umbilical or peripheral (e.g. radial, posterior tibial), suitably calibrated and zeroed, to monitor BP with the measuring dome at the level of the infant's mid-axillary line when supine
- A pre-trial cerebral ultrasound scan demonstrating no evidence of grade 3 or 4 haemorrhage intraventricular haemorrhage (IVH)(i.e. intraparenchymal echodensity or echolucency, with or without acquired cerebral ventriculomegaly)
- A mean blood pressure 1 mmHg or more below a mean BP value equivalent to the gestational age in completed weeks, which persists over a 15 minute period (mean BP \< gestational age)
Exclusion
- Considered non-viable by attending clinicians.
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus, small atrial and/or ventricular septal defect). Infants known to require surgical treatment e.g. congenital diaphragmatic hernia, trache-oesophageal fistula, omphalocele, gastroschisis. Neuromuscular disorders. Frank hypovolaemia. Hydrops Fetalis.
- Cranial ultrasound abnormality grade 3 IVH or more prior to enrolment
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01482559
Start Date
February 1 2015
End Date
October 1 2019
Last Update
October 2 2019
Active Locations (10)
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1
University Hospital Antwerp
Antwerp, Edegem, Belgium, B-2650
2
Katholieke Universiteit Leuven
Oude God, Leuven, Belgium, 3000
3
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
4
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada, H1T 1C9