title: Neonatal abstinence syndrome in European and North American neonates: differences in clinical characteristics derived from a prospective randomized trial.
abstract: BACKGROUND
  Due to the steady increase of substance-dependent pregnant women the neonatal abstinence syndrome has become an increasingly important issue in neonatology. The present study investigates site-specific differences of detailed symptoms and treatment of neonatal abstinence syndrome within the context of an international multicenter clinical trial.
  
  
  METHODS
  Site specific neonatal data analyses from a prospective randomized, double-blind, double-dummy clinical trial (MOTHER study) was performed. A standardized NAS rating and treatment protocol was applied, while non-pharmacological care of NAS symptoms differed across the sites.
  
  
  RESULTS
  Urban US neonates exhibited most neurological symptoms (p<0.001) while in Europe autonomous, respiratory and gastrointestinal symptoms were found significantly more often compared to urban and/or rural US (p<0.05). Methadone produced significantly greater scores than buprenorphine in neurological, behavioural and respiratory symptoms regardless of the sites (ps<0.05). NAS treatment rates in all site clusters were similar for methadone-exposed neonates, while in Europe significantly more buprenorphine-exposed neonates were treated (p=0.001) than in US site clusters. Urban US neonates had significantly higher NAS scores (p<0.01) compared to rural US and European neonates, and needed significantly higher morphine doses (p<0.05) with longer treatment duration. Birth weight, length and head circumference did not differ significantly among the site clusters, but APGAR scores were significantly higher in European (p<0.01) neonates.
  
  
  CONCLUSIONS
  In addition to intrauterine medication exposure other aspects such as different addiction severity of the mothers, different treatment modalities including rooming-in as well as the frequency of NAS ratings may be influencing the course of NAS.
authors: Division of General Paediatrics and Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, Austria.
authors: L
authors: L
authors: Kirchner
authors: Division of General Paediatrics and Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, Austria.
authors: K
authors: K
authors: Graf-Rohrmeister
authors: Division of General Paediatrics and Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, Austria.
authors: K
authors: K
authors: Klebermass-Schrehof
authors: Division of General Paediatrics and Neonatology, Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, Austria.
authors: M
authors: M
authors: Weninger
authors: Faculty of Psychology, University of Vienna, Austria.
authors: R
authors: R
authors: Jagsch
authors: Addiction Clinic, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.
authors: V
authors: V
authors: Metz
authors: Addiction Clinic, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.
authors: A
authors: A
authors: Unger
authors: Addiction Clinic, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Austria.
authors: G
authors: G
authors: Fischer
mesh_terms: D003431:Cross-Cultural Comparison; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009357:Neonatal Abstinence Syndrome / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy; D009293:Opioid-Related Disorders / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy; D011247:Pregnancy; D011446:Prospective Studies; D012307:Risk Factors; D012424:Rural Population; D014481:United States; D014505:Urban Population