Objective To compare outcomes at hospital discharge for preterm infants born before 29 weeks of gestation who had at least one episode of isolated hypotension during their first 72 hours of life for which they did or did not receive antihypotensive treatment.
Design Etude Epidémiologique sur les Petits Ages Gestationnels 2 (EPIPAGE 2) French national prospective population-based cohort study in 2011.
Setting 60 neonatal intensive care units.
Patients All infants with a minimum mean arterial blood pressure less than gestational age (in weeks) (minMAP<GA) within 72 hours of birth. Infants whose reason for receiving antihypotensive treatments was isolated hypotension only were compared with untreated hypotensive infants by propensity score matching.
Treatments Fluid bolus and/or inotropes and/or corticosteroids.
Main outcomes and measures The primary outcome was survival at hospital discharge without major morbidity, defined as any of necrotising enterocolitis, severe cerebral abnormalities, severe bronchopulmonary dysplasia or severe retinopathy of prematurity.
Results Among the 1532 infants with available data, 662 had a minMAP<GA; 206 were treated for unknown or other reasons than isolated hypotension, 131 were treated for isolated hypotension only and 325 were untreated; 119 infants from each of these last two groups were matched. Treated infants had a significantly higher survival rate without major morbidity (61.3% vs 48.7%; OR, 1.67, 95% CI 1.00 to 2.78, p=0.049) and a lower rate of severe cerebral abnormalities (10.1% vs 26.5%, p=0.002).
Conclusions In this population, antihypotensive treatment was associated with improved short-term outcomes. Therapeutic abstention should be cautiously considered for early isolated hypotension in extremely premature infants.
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Collaborators Group information: members of the Hemodynamic EPIPAGE2 Study Group: Gilles Cambonie, MD, PhD (Department of Neonatal Medicine, Montpellier University Hospital, Montpellier, France); Jean-Christophe Rozé, MD, PhD (Department of Neonatal Medicine, Nantes University Hospital, Nantes, France); Pierre-Yves Ancel, MD, PhD (INSERM, U1153,Obstetrical, Perinatal and Pediatric Epidemiology Team, Epidemiology and Biostatistics Sorbonne, Paris, France); Laetitia Marchand-Martin, MS (INSERM, U1153, Obstetrical, Perinatal and Pediatric Epidemiology Team, Epidemiology and Biostatistics Sorbonne, Paris, France); Mélanie Durox, MSc (INSERM, U1153, Obstetrical, Perinatal and Pediatric Epidemiology Team, Epidemiology and Biostatistics Sorbonne, Paris, France); Veronique Gournay,MD, PhD (Pediatric Cardiology Unit, Nantes University Hospital, Nantes, France); Xavier Durrmeyer, MD, PhD (Department of Neonatal Medicine, Intercommunal Hospital, Creteil, France); Laurent Storme, MD, PhD (Department of Neonatal Medicine, Lille University Hospital, Lille, France); Raphael Porcher, PhD (INSERM, U1153, METHODS Team, Epidemiology and Statistics Sorbonne Paris Cité Research Center, Paris, France); Patrice Morville, MD (Department of Neonatal Medicine, Reims University Hospital, Reims, France);Olivier Brissaud, MD (Department of Neonatal Medicine, Bordeaux University Hospital, Bordeaux, France); Patrick Truffert, MD, PhD (Department of Neonatal Medicine, Lille University Hospital, Lille, France); Antoine Bouissou, MD (Department of Neonatal Medicine, Tours University Hospital, Tours, France); Isabelle Ligi, MD, PhD (Department of Neonatal Medicine, Marseille University Hospital, Marseille, France); Marie-Odile Marcoux, MD (Department of Neonatal Medicine, Toulouse University Hospital, Toulouse, France); Fabrice Cneude,MD (Department of Neonatal Medicine, Grenoble University Hospital, Grenoble, France); Geraldine Gascoin, MD, PhD (Department of Neonatal Medicine, Angers University Hospital); Gerard Thiriez, MD, PhD (Department of Neonatal Medicine, Besançon University Hospital, Besançon, France); Hugues Patural, MD ,PhD (Department of Neonatal Medicine, St Etienne University Hospital, St Etienne, France); Doriane Madeleneau, MD (Department of Neonatal Medicine, Cochin University Hospital, Paris, France); Antoine Burguet, MD, PhD (Department of Neonatal Medicine, Dijon University Hospital, Dijon, France) and Patrick Pladys, MD, PhD (Department of Neonatal Medicine, Rennes University Hospital, Rennes, France).
Contributors XD, RP, GC, J-CR, LS, P-YA and GC initiated and designed the protocol. XD and LM-M participated in the data collection. LM-M performed all data analysis and RP validated them. XD and GC wrote the first draft. All authors participated in data interpretation and reviewing of the manuscript. All the coauthors approved the final manuscript.
Funding This study was supported by the French Institute of Public Health Research /Institute of Public Health and its partners the French Health Ministry, the National Institute of Health and Medical Research, the National Institute of Cancer and the National Solidarity Fund for Autonomy; grant ANR-11-EQPX-0038 from the National Research Agency through the French Equipex Program of Investments in the Future and the PremUp Foundation.
Competing interests None declared.
Ethics approval EPIPAGE-2 was approved by the National Data Protection Authority (Commission Nationale de l'Informatique et des Libertés (CNIL) n°911009) and by two ethics committees: consultative committee on the treatment of information on personal health data for research purposes (approval granted 18 November 2010; reference 10.626) and the committee for the protection of people participating in biomedical research (approval granted 18 March 2011; reference Comité de Protection des Personnes (CPP) SC-2873).
Provenance and peer review Not commissioned; externally peer reviewed.
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