Management of Hypotension In the Preterm Infant

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.

Conditions

• Hypotension
• Low Blood Pressure
• Intraventricular Hemorrhage of Prematurity

Interventions

DRUG

Dopamine hydrochloride

Active drug substance 1.5 mg in 1 mL IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min

DRUG

Dextrose 5%

IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min

Sponsors & Collaborators

• Cork University Hospital

  collaborator OTHER

• Coombe Women and Infants University Hospital

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• National Maternity Hospital, Ireland

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Institute for the Care of Mother and Child, Prague, Czech Republic

  collaborator OTHER

• GABO:mi

  collaborator INDUSTRY

• BrePco Biopharma Limited

  collaborator OTHER

• University College, London

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Clininfo S.A.

  collaborator INDUSTRY

• University College Cork

  lead OTHER

Principal Investigators

• Eugene Dempsey · University College Cork

• Peter Filan · Cork University Maternity Hospital

• Gunnar Naulaers · KU Leuven

• Zybnek Stranak · Univerzita Karlova v Praze

• Keith Barrington · St. Justine's Hospital

• Colm O Donnell · University College Dublin

• Jan Miletin · Coombe Women and Infants University Hospital

• Po-Yin Cheung · University of Alberta

• David Corcoran · Royal College of Surgeons in Ireland

• Neil Marlow · University College, London

• Gerard Pons · Institut National de la Santé Et de la Recherche Médicale, France

• David Van Laere · Neonatale Intensieve Zorgen

• David Millar · Royal Maternity Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

27 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2017-09-30

Completion

2019-10-31

Countries

• Belgium
• Canada
• Czechia
• Ireland
• United Kingdom

Study Locations