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.

Clinical Pharmacology Groupe Hospitalier Cochin Broca Hôtel Dieu AP HP Paris France

Department of Neonatology Tomas Bata University in Zlin Zlin Zlínský Kraj Czech Republic

Department of Paediatric and Child Health and INFANT Research Centre University College Cork Cork Ireland

Department of Pediatrics and Neonatal Care Ostravska Univerzita Ostrava Moravskoslezský Czech Republic

Department of Pediatrics University of Alberta Edmonton Alberta Canada

Faculty of Medicine and Health Sciences Royal College of Surgeons in Ireland Dublin Ireland

Institute for the Care of Mother and Child 3rd Faculty of Medicine Charles University Prague Czech Republic

Institute for Womens Health University College London London UK

Neonatal Intensive Care Unit The National Maternity Hospital Dublin Ireland

Néonatologie Centre Hospitalier Universitaire Sainte Justine Montreal Quebec Canada

Neonatology Katholieke Universiteit Leuven Leuven Belgium

NICU UZ Antwerp Edegem Antwerp Belgium

Paediatric and Newborn Medicine Coombe Women and Infants University Hospital Dublin Ireland

J Perinatol. 2023 Feb;43(2):253-256. doi: 10.1038/s41372-022-01554-8. PubMed

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Machine Learning Detects Intraventricular Haemorrhage in Extremely Preterm Infants

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NCT01482559