Objective To determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.
Design Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.
Setting 10 sites across Europe and Canada.
Participants Infants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.
Intervention Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).
Primary outcome Survival to 36 weeks of PMA without severe brain injury.
Results The trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).
Conclusion Though this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.
Trial registration number NCT01482559, EudraCT 2010-023988-17.
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Contributors EMD conceptualised, designed and coordinated the study, coordinated and supervised the data collection, analysed the data and drafted the initial manuscript, and revised the manuscript. JMi, GN, P-YC, JDC, AFE-K, GBB and ZS helped to conceptualise and design the study, coordinated and supervised the data collection, drafted the initial manuscript and revised the manuscript. KJB, NM, CPFO’D and DVL helped to conceptualise and design the study, drafted the initial manuscript and revised the manuscript. GP conceptualised and designed the study and revised the manuscript. VL made a substantial contribution to the analysis and interpretation of data and reviewed and revised the manuscript. JMa and HW coordinated and supervised the data collection, collected data, and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.
Funding This work was supported by the EU FP7/2007-2013 under grant agreement number 260777 (the HIP Trial) and the EU Seventh Framework Programme (260777).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The research ethics committee at all participating sites approved this trial.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available. It is currently not possible to share the HIP Trial data set.
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