Management of Hypotension In the Preterm Infant (HIP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by University College Cork

Sponsor:

Collaborators:

Cork University Hospital

Coombe Women and Infants University Hospital

Royal College of Surgeons, Ireland

National Maternity Hospital, Ireland

University Hospital, Antwerp

Katholieke Universiteit Leuven

University of Alberta

St. Justine's Hospital

Institute for the Care of Mother and Child, Prague

Royal Jubilee Maternity Service, Belfast

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

ClinicalTrials.gov Identifier:

NCT01482559

First received: November 27, 2011

Last updated: January 27, 2015

Last verified: January 2015

History of Changes

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:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding Low Blood Pressure

Drug Information available for: Dopamine Dopamine hydrochloride Dextrose

Genetic and Rare Diseases Information Center resources: Periventricular Leukomalacia Leukomalacia

U.S. FDA Resources

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:	January 2015
Estimated Study Completion Date:	January 2018
Estimated Primary Completion Date:	January 2018 (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 (Child)
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 (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

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	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	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	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