drugset / Trial / NCT01482559

Management of Hypotension In the Preterm Infant

Phase 3 Terminated 58 enrolled University College Cork BrePco Biopharma Limited · collab Clininfo S.A. · collab Coombe Women and Infants University Hospital · collab Cork University Hospital · collab GABO:mi · collab Institut National de la Santé Et de la Recherche Médicale, France · collab Institute for the Care of Mother and Child, Prague, Czech Republic · collab KU Leuven · collab National Maternity Hospital, Ireland · collab Royal College of Surgeons, Ireland · collab St. Justine's Hospital · collab University College, London · collab University Hospital, Antwerp · collab University of Alberta · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-02
Primary completion: 2017-09
Completion: 2019-10

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study ceased enrolling due to poor overall recruitment. Long-term follow up of enrolled participants ongoing.”

paper In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). PMID 33627329 ↗

Publications

Dempsey EM, Barrington KJ, Marlow N, O'Donnell CPF, Miletin J, Naulaers G, Cheung PY, Corcoran JD, El-Khuffash AF, Boylan GB, Livingstone V, Pons G, Macko J, Van Laere D, Wiedermannova H, Stranak Z; HIP consortium. Hypotension in Preterm Infants (HIP) randomised trial. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):398-403. doi: 10.1136/archdischild-2020-320241. Epub 2021 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dopamine	Small molecule	5 ug/kg	Intravenous
Subject	Dopamine	Small molecule	20 ug/kg	Intravenous