title: Racemic adrenaline and inhalation strategies in acute bronchiolitis.
abstract: BACKGROUND
  Acute bronchiolitis in infants frequently results in hospitalization, but there is no established consensus on inhalation therapy--either the type of medication or the frequency of administration--that may be of value. We aimed to assess the effectiveness of inhaled racemic adrenaline as compared with inhaled saline and the strategy for frequency of inhalation (on demand vs. fixed schedule) in infants hospitalized with acute bronchiolitis.
  
  
  METHODS
  In this eight-center, randomized, double-blind trial with a 2-by-2 factorial design, we compared inhaled racemic adrenaline with inhaled saline and on-demand inhalation with fixed-schedule inhalation (up to every 2 hours) in infants (<12 months of age) with moderate-to-severe acute bronchiolitis. An overall clinical score of 4 or higher (on a scale of 0 to 10, with higher scores indicating more severe illness) was required for study inclusion. Any use of oxygen therapy, nasogastric-tube feeding, or ventilatory support was recorded. The primary outcome was the length of the hospital stay, with analyses conducted according to the intention-to-treat principle.
  
  
  RESULTS
  The mean age of the 404 infants included in the study was 4.2 months, and 59.4% were boys. Length of stay, use of oxygen supplementation, nasogastric-tube feeding, ventilatory support, and relative improvement in the clinical score from baseline (preinhalation) were similar in the infants treated with inhaled racemic adrenaline and those treated with inhaled saline (P>0.1 for all comparisons). On-demand inhalation, as compared with fixed-schedule inhalation, was associated with a significantly shorter estimated mean length of stay--47.6 hours (95% confidence interval [CI], 30.6 to 64.6) versus 61.3 hours (95% CI, 45.4 to 77.2; P=0.01) - as well as less use of oxygen supplementation (in 38.3% of infants vs. 48.7%, P=0.04), less use of ventilatory support (in 4.0% vs. 10.8%, P=0.01), and fewer inhalation treatments (12.0 vs. 17.0, P<0.001).
  
  
  CONCLUSIONS
  In the treatment of acute bronchiolitis in infants, inhaled racemic adrenaline is not more effective than inhaled saline. However, the strategy of inhalation on demand appears to be superior to that of inhalation on a fixed schedule. (Funded by Medicines for Children; ClinicalTrials.gov number, NCT00817466; EudraCT number, 2009-012667-34.).
authors.affiliation: Department of Pediatrics, Oslo University Hospital, Oslo, Norway.
authors.forename: Håvard Ove
authors.initials: HO
authors.lastname: Skjerven
authors.forename: Jon Olav Gjengstø
authors.initials: JO
authors.lastname: Hunderi
authors.forename: Sabine Kristin
authors.initials: SK
authors.lastname: Brügmann-Pieper
authors.forename: Anne Charlotte
authors.initials: AC
authors.lastname: Brun
authors.forename: Hanne
authors.initials: H
authors.lastname: Engen
authors.forename: Leif
authors.initials: L
authors.lastname: Eskedal
authors.forename: Marius
authors.initials: M
authors.lastname: Haavaldsen
authors.forename: Bente
authors.initials: B
authors.lastname: Kvenshagen
authors.forename: Jon
authors.initials: J
authors.lastname: Lunde
authors.forename: Leif Bjarte
authors.initials: LB
authors.lastname: Rolfsjord
authors.forename: Christian
authors.initials: C
authors.lastname: Siva
authors.forename: Truls
authors.initials: T
authors.lastname: Vikin
authors.forename: Petter
authors.initials: P
authors.lastname: Mowinckel
authors.forename: Kai-Håkon
authors.initials: KH
authors.lastname: Carlsen
authors.forename: Karin C
authors.initials: KC
authors.lastname: Lødrup Carlsen
mesh_terms: D000208:Acute Disease; D000280:Administration, Inhalation; D000367:Age Factors; D001988:Bronchiolitis / Q000188:drug therapy* / Q000628:therapy; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004837:Epinephrine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000150:complications; D007223:Infant; D007536:Isomerism; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D010102:Oxygen Inhalation Therapy; D064705:Racepinephrine; D012121:Respiration, Artificial; D012737:Sex Factors; D012965:Sodium Chloride / Q000008:administration & dosage*
chemical_list: D012965:Sodium Chloride; D064705:Racepinephrine; D004837:Epinephrine