Study ceased enrolling due to poor overall recruitment. Long-term follow up of enrolled participants ongoing.
HIP
Management of Hypotension In Preterm Infants: The HIP Trial Protocol for a Randomized Controlled Trial of Hypotension Management in the Extremely Low Gestational Age Newborn
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
58
5 countries
10
Study Start
February 2015
Actual (reported)Primary Completion
September 2017
Actual (reported)Study Completion
October 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2011
Actual (reported)November 30, 2011
Actual (reported)February 2015
Actual (reported)September 2017
Actual (reported)October 2019
Actual (reported)First Co-Primary Outcome Measure: Survival to 36 weeks postmenstrual age free of severe brain injury
Survival to 36 weeks postmenstrual age free of severe brain injury (moderate or severe ventricular dilatation, intracerebral echodense lesions, and cystic periventricular leukomalacia) on cranial ultrasound at 36 weeks or discharge home which ever is the earlier.
36 weeks
Second Co-Primary Outcome Measure: Survival without moderate or serious disability as defined using consensus criteria for neurodevelopmental impairment.
Families will be offered routine appointments as per the local follow-up system. At 12-months, the physician will complete a simple disability assessment and all surviving infants will have a locally performed formal neurodisability assessment at 24 months age corrected for weeks of prematurity defined using criteria set out in the consensus statement "Health status...." (ww bapm.org/publications).
2 years of age
IV Infusion
IV Infusion
Active drug substance 1.5 mg in 1 mL IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
University Hospital Antwerp
Antwerp, Edegem, B-2650, Belgium
Katholieke Universiteit Leuven
Oude God, Leuven, 3000, Belgium
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, H1T 1C9, Canada
Univerzita Karlova v Praze
Prague, 11636, Czechia
Coombe Women and Infants University Hospital
Dublin, Dublin, 8, Ireland
Cork University Maternity Hospital
Cork, Ireland
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.
Eugene Dempsey
University College Cork
Peter Filan
Cork University Maternity Hospital
Gunnar Naulaers
KU Leuven
Zybnek Stranak
Univerzita Karlova v Praze
58 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2011
First Posted
November 30, 2011
Study Start
February 2015
Actual (reported)Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage
All cause mortality at 36 weeks gestational age
36 weeks gestational age
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Royal College of Surgeons in Ireland
Dublin, Ireland
University College Dublin
Dublin, Ireland
Royal Maternity Hospital
Belfast, BT12 6BA, United Kingdom
Keith Barrington
St. Justine's Hospital
Colm O Donnell
University College Dublin
Jan Miletin
Coombe Women and Infants University Hospital
Po-Yin Cheung
University of Alberta
David Corcoran
Royal College of Surgeons in Ireland
Neil Marlow
University College, London
Gerard Pons
Institut National de la Santé Et de la Recherche Médicale, France
David Van Laere
Neonatale Intensieve Zorgen
David Millar
Royal Maternity Hospital
Primary Completion
September 2017
Actual (reported)Study Completion
October 2019
Actual (reported)Last Updated
October 2, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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