(duplicate) The HIP Trial - Hypotension in the Preterm Infant: Final V
Research type
Research Study
Full title
Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn
IRAS ID
202215
Contact name
David Sweet
Contact email
Sponsor organisation
BrepCo Biopharma Ltd
Eudract number
2010-023988-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 6 days
Research summary
Research Summary
The HIP trial is a study taking place in a number of centres around the world and is a trial comparing two different strategies for the management of hypotension ( low blood pressure) in extremely low gestational age newborns (babies delivered less than 28 weeks ). Low blood pressure (hypotension) is a common problem in the premature newborn and can affect over 50% of all babies delivered less than 28 weeks.
In this study, infants whose blood pressure becomes low within the first 72 hours of life will be randomly assigned to one of 2 approaches: Approach 1 - infants will receive a drug called Dopamine and fluid (saline) OR approach 2 - infants will receive a placebo (consisting of sugar and water) and fluid (saline).
Both approaches (either receiving Dopamine or saline only) are used in neonatal units all over the world. This research study is trying to find out which is better.
Summary of Results
https://cordis.europa.eu/docs/results/260/260777/periodic4-attachment-2-publishable-summary.pdf
REC name
HSC REC B
REC reference
17/NI/0058
Date of REC Opinion
26 May 2017
REC opinion
Further Information Favourable Opinion