title: Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux.
abstract: OBJECTIVE
  To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.
  
  
  METHODS
  Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period.
  
  
  RESULTS
  The reflux index fell significantly during omeprazole treatment compared with placebo (-8.9%+/-5.6%, -1.9%+/-2.0%, P<.001). Cry/fuss time decreased from baseline (267+/-119), regardless of treatment sequence (period 1, 203+/-99, P<.04; period 2, 188+/-121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8+/-1.6, 4.8+/-2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo.
  
  
  CONCLUSIONS
  Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.
authors.affiliation: Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, North Adelaide, SA 5006, Australia. moored@wch.sa.gov.au
authors.forename: David John
authors.initials: DJ
authors.lastname: Moore
authors.forename: Billy Siang-Kuo
authors.initials: BS
authors.lastname: Tao
authors.forename: David Robin
authors.initials: DR
authors.lastname: Lines
authors.forename: Craig
authors.initials: C
authors.lastname: Hirte
authors.forename: Margaret Lila
authors.initials: ML
authors.lastname: Heddle
authors.forename: Geoffrey Paul
authors.initials: GP
authors.lastname: Davidson
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004942:Esophagitis, Peptic; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D018730:Infant Behavior / Q000187:drug effects*; D008297:Male; D009853:Omeprazole / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole