Management of Hypotension In the Preterm Infant (HIP)
This study is not yet open for participant recruitment.
Verified July 2012 by University College Cork
Sponsor:
University College Cork
Collaborators:
BrePco Biopharma Limited
Cork University Hospital
Katholieke Universiteit Leuven
Univerzita Karlova v Praze
St. Justine's Hospital
University College Dublin
Coombe Women and Infants University Hospital
University of Alberta
Royal College of Surgeons, Ireland
GABO:milliarium mbH & Co. KG
National de la Santé et de la Recherche Medicale
University College, London
Clininfo S.A.
Information provided by (Responsible Party):
Dr. Gene Dempsey, University College Cork
ClinicalTrials.gov Identifier:
NCT01482559
First received: November 27, 2011
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
The HIP trial is a large pragmatic, multinational, randomised trial of two different strategies for the management of hypotension in ELGA infants (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 | Intervention | Phase |
|---|---|---|
|
Hypotension Low Blood Pressure Prematurity of Fetus |
Drug: Dopamine hydrochloride Drug: Dextrose 5% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by University College Cork:
Primary Outcome Measures:
- First Co-Primary Outcome Measure: Survival to 36 weeks postmenstrual age free of severe brain injury [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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).
Secondary Outcome Measures:
- All cause mortality at 36 weeks gestational age [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 830 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: dextrose 5%
IV Infusion
|
Drug: Dextrose 5%
IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
Other Name: Placebo
|
|
Experimental: Dopamine Hydrochloride
IV Infusion
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 23 Weeks to 27 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 (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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482559
Contacts
| Contact: Eugene Dempsey | 00 353 21 4920525 | Gene.Dempsey@hse.ie |
| Contact: Niamh O Shea | 00 353 87 9696229 | N.oshea@ucc.ie |
Locations
| Belgium | |
| Katholieke Universiteit Leuven | Not yet recruiting |
| Oude God, Leuven, Belgium, 3000 | |
| Contact: Gunnar Naulaers 003216324010 gunnar.naulaers@uzleuven.be | |
| Principal Investigator: Gunnar Naulaers | |
| Canada, Alberta | |
| University of Alberta | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 2R3 | |
| Contact: Po-Yin Cheung 0017804923111 poyin@ualberta.ca | |
| Principal Investigator: Po-Yin Cheung | |
| Canada, Quebec | |
| Centre hospitalier universitaire Sainte-Justine | Not yet recruiting |
| Montreal, Quebec, Canada, H1T 1C9 | |
| Contact: Keith Barrington 0015143454931 keith.barrington@umontreal.ca | |
| Principal Investigator: Keith Barrington | |
| Czech Republic | |
| Univerzita Karlova v Praze | Not yet recruiting |
| Ovocný trh 5, Prague, Czech Republic, 11636 | |
| Contact: Zbyněk Straňák 00420224491111 z.stranak@seznam.cz | |
| Principal Investigator: Zbyněk Straňák | |
| Ireland | |
| Coombe Women and Infants University Hospital | Not yet recruiting |
| Dublin 8, Dublin, Ireland, 8 | |
| Contact: Jan Miletin 0035314085200 miletinj@yahoo.com | |
| Principal Investigator: Jan Miletin | |
| University College Dublin | Not yet recruiting |
| Dun Laoghaire, Rathdown, Dublin, Ireland | |
| Contact: Colm O Donnell 0035317167777 codonnell@nmh.ie | |
| Principal Investigator: Colm O Donnell | |
| Cork University Maternity Hospital | Not yet recruiting |
| Cork, Ireland | |
| Contact: Eugene Dempsey 00 353 21 4920525 gene.dempsey@hse.ie | |
| Contact: Niamh O Shea 00 353 879696229 n.oshea@ucc.ie | |
| Principal Investigator: Peter Filan | |
| Royal College of Surgeons in Ireland | Not yet recruiting |
| Dublin, Ireland | |
| Contact: David Corcoran 0035314022100 dcorcoran@rotunda.ie | |
| Principal Investigator: David Corcoran | |
Sponsors and Collaborators
University College Cork
BrePco Biopharma Limited
Cork University Hospital
Katholieke Universiteit Leuven
Univerzita Karlova v Praze
St. Justine's Hospital
University College Dublin
Coombe Women and Infants University Hospital
University of Alberta
Royal College of Surgeons, Ireland
GABO:milliarium mbH & Co. KG
National de la Santé et de la Recherche Medicale
University College, London
Clininfo S.A.
Investigators
| Study Director: | Eugene Dempsey | University College Cork |
| Principal Investigator: | Peter Filan | Cork University Maternity Hospital |
| Principal Investigator: | Gunnar Naulaers | Katholieke Universiteit 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 | National de la Santé et de la Recherche Medicale |
More Information
No publications provided
| Responsible Party: | Dr. Gene Dempsey, Dr Eugene Dempsey, Consultant Neonatologist, University College Cork |
| ClinicalTrials.gov Identifier: | NCT01482559 History of Changes |
| Other Study ID Numbers: | HIP-FP7-BrePco, 2010-023988-17 |
| Study First Received: | November 27, 2011 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Ireland: Irish Medicines Board Ireland: Research Ethics Committee Belgium: Ethics Committee Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by University College Cork:
|
Dopamine IVH PVL Neurodisability Infant |
Additional relevant MeSH terms:
|
Hypotension Vascular Diseases Cardiovascular Diseases Dopamine Dopamine Agents Cardiotonic Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013