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Hypotension in Preterm Infants (HIP) randomised trial
EM. Dempsey, KJ. Barrington, N. Marlow, CPF. O'Donnell, J. Miletin, G. Naulaers, PY. Cheung, JD. Corcoran, AF. El-Khuffash, GB. Boylan, V. Livingstone, G. Pons, J. Macko, D. Van Laere, H. Wiedermannova, Z. Straňák, HIP consortium
Language English Country Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 1997-01-01 to 6 months ago
Health & Medicine (ProQuest)
from 1997-01-01 to 6 months ago
- MeSH
- Dopamine administration & dosage adverse effects therapeutic use MeSH
- Double-Blind Method MeSH
- Gestational Age MeSH
- Hypotension drug therapy mortality MeSH
- Cardiotonic Agents administration & dosage adverse effects therapeutic use MeSH
- Humans MeSH
- Infant, Extremely Premature * MeSH
- Infant, Newborn MeSH
- Brain Injuries chemically induced MeSH
- Check Tag
- Humans MeSH
- Infant, Newborn MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
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 Pediatrics University of Alberta Edmonton Alberta Canada
Faculty of Medicine and Health Sciences Royal College of Surgeons in Ireland Dublin Ireland
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
References provided by Crossref.org
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- $a 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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