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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
Sponsor:
Collaborators:
Cork University Hospital
Coombe Women and Infants University Hospital
Royal College of Surgeons, Ireland
National Maternity Hospital, Ireland
University Hospital, Antwerp
KU Leuven
University of Alberta
St. Justine's Hospital
Institute for the Care of Mother and Child, Prague, Czech Republic
GABO:mi
BrePco Biopharma Limited
University College, London
Institut National de la Santé Et de la Recherche Médicale, France
Clininfo S.A.
Information provided by (Responsible Party):
Dr. Gene Dempsey, University College Cork

Brief 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.


Condition or disease Intervention/treatment Phase
Hypotension Low Blood Pressure Intraventricular Hemorrhage of Prematurity Drug: Dopamine hydrochloride Drug: Dextrose 5% Phase 3

  Show Detailed Description

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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
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




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


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

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Responsible Party: Dr. Gene Dempsey, Professor Eugene Dempsey, Consultant Neonatologist, University College Cork
ClinicalTrials.gov Identifier: NCT01482559     History of Changes
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
Keywords provided by Dr. Gene Dempsey, University College Cork:
Dopamine
Intraventricular haemorrhage
Periventricular Leukomalacia
Neurodisability
Infant
Additional relevant MeSH terms:
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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