Hypotension in Preterm Infants (HIP) randomised trial
| Autor: | John David Corcoran, Geraldine B. Boylan, David Van Laere, Eugene M. Dempsey, Colm P F O'Donnell, Jan Miletin, Afif El-Khuffash, Keith J. Barrington, Hana Wiedermannova, Gunnar Naulaers, Jozef Macko, Po-Yin Cheung, Vicki Livingstone, Neil Marlow, Gérard Pons, Zbyněk Straňák |
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| Přispěvatelé: | HIP Consortium |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Cardiotonic Agents medicine.medical_treatment Dopamine Gestational Age TERM DIAGNOSIS Placebo Pediatrics THERAPY neonatology 03 medical and health sciences AGE 0302 clinical medicine Double-Blind Method 030225 pediatrics MANAGEMENT CARDIOVASCULAR SUPPORT Medicine Humans 030212 general & internal medicine Neonatology Saline Original Research OUTCOMES Science & Technology business.industry Postmenstrual Age Infant Newborn Obstetrics and Gynecology Gestational age General Medicine INOTROPES Blood pressure Anesthesia Brain Injuries Infant Extremely Premature cardiology Pediatrics Perinatology and Child Health Gestation Human medicine Bolus (digestion) Hypotension pharmacology business Life Sciences & Biomedicine EARLY BLOOD-PRESSURE |
| Zdroj: | Archives of Disease in Childhood. Fetal and Neonatal Edition Archives of disease in childhood : fetal and neonatal edition |
| ISSN: | 1468-2052 1359-2998 |
| Popis: | ObjectiveTo 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.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants 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.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe 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).ConclusionThough 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 numberNCT01482559, EudraCT 2010-023988-17. |
| Databáze: | OpenAIRE |
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