Management of Hypotension In the Preterm Infant (HIP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University College Cork
Sponsor:
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
Institut National de la Santé Et de la Recherche Médicale, France
Neonatale Intensieve Zorgen
Royal Maternity Hospital
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: June 26, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Hypotension
Low Blood Pressure
Intraventricular Hemorrhage of Prematurity
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: August 2013
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:

  1. Gestational age at birth less than 28 completed weeks, i.e. up to and including 27 weeks and 6 days.
  2. Within 72 hours of birth
  3. 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
  4. 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)
  5. 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:

  1. Considered non-viable by attending clinicians.
  2. 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.
  3. Cranial ultrasound abnormality grade 3 IVH or more prior to enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Hospital Antwerp Not yet recruiting
Wilrijkstraat 10, Edegem, Belgium, B-2650
Contact: David Van Laere    00 32 3 821 58 07    David.VanLaere@uza.be   
Principal Investigator: David Van Laere         
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         
United Kingdom
Royal Maternity Hospital Not yet recruiting
Belfast, United Kingdom, BT12 6BA
Contact: David Millar       david.millar@belfasttrust.hscni.net   
Principal Investigator: David Millar         
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
Institut National de la Santé Et de la Recherche Médicale, France
Neonatale Intensieve Zorgen
Royal Maternity Hospital
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 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
  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: June 26, 2013
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
Intraventricular haemorrhage
Periventricular Leukomalacia
Neurodisability
Infant

Additional relevant MeSH terms:
Hemorrhage
Hypotension
Cerebral Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System 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 July 29, 2014