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Prolonged Sedation and/or Analgesia and 5-Year Neurodevelopment Outcome in Very Preterm InfantsResults From the EPIPAGE Cohort
Jean-Christophe Rozé, MD, PhD;
Sophie Denizot, MD;
Ricardo Carbajal, MD, PhD;
Pierre-Yves Ancel, MD, PhD;
Monique Kaminski, MD, PhD;
Catherine Arnaud, MD, PhD;
Patrick Truffert, MD, PhD;
Stéphane Marret, MD, PhD;
Jaqueline Matis, MD;
Gérard Thiriez, MD;
Gilles Cambonie, MD, PhD;
Monique André, MD;
Béatrice Larroque, MD, PhD;
Gérard Bréart, MD, PhD
Arch Pediatr Adolesc Med. 2008;162(8):728-733.
Objective To describe the long-term outcome of very preterm infants receiving prolonged sedation and/or analgesia and examine the relationship between prolonged sedation and/or analgesia and this long-term outcome.
Design A prospective population-based study (Etude EPIdémiologique sur les Petits Ages GEstationnels [EPIPAGE]). To reduce bias, the propensity score method was used.
Setting Nine regions of France.
Participants The study population included very preterm infants of fewer than 33 weeks' gestational age, born in 1997, who received mechanical ventilation and/or surgery.
Main Exposure Prolonged exposure to sedative and/or analgesic drugs in the neonatal period, defined as exposure of more than 7 days to sedative and/or opioid drugs.
Main Outcome Measure Presence of moderate or severe disability at 5 years of age.
Results The analysis concerns 1572 premature infants who received mechanical ventilation for whom information about exposure to prolonged sedation and/or analgesia in the neonatal period was available. A total of 115 were exposed and 1457 were not exposed. There was no significant difference between the number of patients lost to follow-up from the group of very preterm infants who were exposed to prolonged sedation and/or analgesia and the group who were not. Exposed very preterm infants had severe or moderate disability at 5 years (41/97; 42%) more often than those who were not exposed (324/1248; 26%). After adjustment for gestational age and propensity score, this association was no longer statistically significant (adjusted relative risk, 1.0; 95% confidence interval, 0.8-1.2).
Conclusion Prolonged sedation and/or analgesia is not associated with a poor 5-year neurological outcome after adjustment for the propensity score.
Author Affiliations: INSERM CIC004 and Department of Neonatal Medicine, Nantes University Hospital (Drs Rozé and Denizot); Centre National de Ressources de Lutte Contre la Douleur, Hôpital D'enfants Armand-Trousseau (Dr Carbajal); INSERM UMR S149, IFR69, Epidemiological Research Unit on Perinatal and Women's Health, Tenon University Hospital and Pierre et Marie Curie University, Paris (Drs Ancel, Kaminski, Larroque, and Bréart); Institut National de la Santé et de la Recherche Medicale, U558 Département de Santé Publique, Faculté de Médecine, Toulouse (Dr Arnaud); Department of Neonatal Medicine, Lille University Hospital, Lille (Dr Truffert); Department of Neonatalogy, Rouen University Hospital, Rouen (Dr Marret); Department of Neonatalogy, Strasbourg University Hospital, Strasbourg (Dr Matis); Department of Neonatal Medicine, Besancon University Hospital, Besancon (Dr Thiriez); Department of Neonatal Medicine, Montpellier University Hospital, Montpellier (Dr Cambonie); and Maternité Régionale, Nancy University Hospital, Nancy, France (Dr André).
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