Overview

Management of Hypotension In the Preterm Infant

Status:
Terminated
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
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 versus a restricted with placebo approach). HYPOTHESIS: A restricted approach to the management of hypotension in extremely low gestational age newborns will result in improved neonatal and long-term developmental outcomes. PRIMARY OBJECTIVE: To determine whether a restricted approach to the management of hypotension compared to using dopamine as first line pressor agent in infants born less than 28 weeks of gestation within the first 72 hrs after birth (transitional period), improves survival without significant brain injury at 36 weeks postmenstrual age (PMA) and improves survival without moderate or severe neurodevelopmental disability at 2 years corrected age.
Phase:
Phase 3
Details
Lead Sponsor:
University College Cork
Collaborators:
BrePco Biopharma Limited
Clininfo S.A.
Coombe Women and Infants University Hospital
Cork University Hospital
GABO:mi
Institut National de la Santé Et de la Recherche Médicale, France
Institute for the Care of Mother and Child, Prague, Czech Republic
Katholieke Universiteit Leuven
KU Leuven
National Maternity Hospital, Ireland
Royal College of Surgeons, Ireland
Royal Jubilee Maternity Service, Belfast
St. Justine's Hospital
University College, London
University Hospital, Antwerp
University of Alberta
Treatments:
Dopamine
Dopamine Agents