Management of Hypotension In the Preterm Infant (HIP)
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ClinicalTrials.gov Identifier: NCT01482559 |
Recruitment Status :
Terminated
(Study ceased enrolling due to poor overall recruitment. Long-term follow up of enrolled participants ongoing.)
First Posted : November 30, 2011
Last Update Posted : October 2, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypotension Low Blood Pressure Intraventricular Hemorrhage of Prematurity | Drug: Dopamine hydrochloride Drug: Dextrose 5% | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | February 2015 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | October 2019 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: dextrose 5%
IV Infusion
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Drug: Dextrose 5%
IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
Other Name: Placebo |
Experimental: Dopamine Hydrochloride
IV Infusion
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Drug: Dopamine hydrochloride
Active drug substance 1.5 mg in 1 mL IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
Other Name: ATC Code: C01CA04 |
- First Co-Primary Outcome Measure: Survival to 36 weeks postmenstrual age free of severe brain injury [ Time Frame: 36 weeks ]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.
- Second Co-Primary Outcome Measure: Survival without moderate or serious disability as defined using consensus criteria for neurodevelopmental impairment. [ Time Frame: 2 years of age ]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).
- All cause mortality at 36 weeks gestational age [ Time Frame: 36 weeks gestational age ]

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Ages Eligible for Study: | 23 Weeks to 27 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482559
Belgium | |
University Hospital Antwerp | |
Antwerp, Edegem, Belgium, B-2650 | |
Katholieke Universiteit Leuven | |
Oude God, Leuven, Belgium, 3000 | |
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2R3 | |
Canada, Quebec | |
Centre hospitalier universitaire Sainte-Justine | |
Montreal, Quebec, Canada, H1T 1C9 | |
Czechia | |
Univerzita Karlova v Praze | |
Prague, Czechia, 11636 | |
Ireland | |
Coombe Women and Infants University Hospital | |
Dublin 8, Dublin, Ireland, 8 | |
Cork University Maternity Hospital | |
Cork, Ireland | |
Royal College of Surgeons in Ireland | |
Dublin, Ireland | |
University College Dublin | |
Dublin, Ireland | |
United Kingdom | |
Royal Maternity Hospital | |
Belfast, United Kingdom, BT12 6BA |
Study Director: | Eugene Dempsey | University College Cork | |
Principal Investigator: | Peter Filan | Cork University Maternity Hospital | |
Principal Investigator: | Gunnar Naulaers | KU Leuven | |
Principal Investigator: | Zybnek Stranak | Univerzita Karlova v Praze | |
Principal Investigator: | Keith Barrington | St. Justine's Hospital | |
Principal Investigator: | Colm O Donnell | University College Dublin | |
Principal Investigator: | Jan Miletin | Coombe Women and Infants University Hospital | |
Principal Investigator: | Po-Yin Cheung | University of Alberta | |
Principal Investigator: | David Corcoran | Royal College of Surgeons in Ireland | |
Principal Investigator: | Neil Marlow | University College, London | |
Principal Investigator: | Gerard Pons | Institut National de la Santé Et de la Recherche Médicale, France | |
Principal Investigator: | David Van Laere | Neonatale Intensieve Zorgen | |
Principal Investigator: | David Millar | Royal Maternity Hospital |
Responsible Party: | Dr. Gene Dempsey, Professor Eugene Dempsey, Consultant Neonatologist, University College Cork |
ClinicalTrials.gov Identifier: | NCT01482559 |
Other Study ID Numbers: |
HIP-FP7-BrePco 2010-023988-17 ( EudraCT Number ) |
First Posted: | November 30, 2011 Key Record Dates |
Last Update Posted: | October 2, 2019 |
Last Verified: | September 2019 |
Dopamine Intraventricular haemorrhage Periventricular Leukomalacia Neurodisability Infant |
Hypotension Hemorrhage Pathologic Processes Vascular Diseases Cardiovascular Diseases Dopamine Cardiotonic Agents Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |