title: Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study.
abstract: OBJECTIVE
  Delivery of inhaled medications to infants is usually very demanding and is often associated with crying and mask rejection. It has been suggested that aerosol administration during sleep may be an attractive alternative. Previous studies in sleeping children were disappointing as most of the children awoke and rejected the treatment. The SootherMask (SM) is a new, gentle and innovative approach for delivering inhaled medication to infants and toddlers. The present pilot study describes the feasibility of administering inhaled medications during sleep using the SM.
  
  
  METHODS
  Prospective observational study.
  
  
  METHODS
  Out patients.
  
  
  METHODS
  13 sleeping infants with recurrent wheezing who regularly used pacifiers and were <12 months old.
  
  
  METHODS
  Participants inhaled technetium99mDTPA-labelled normal saline aerosol delivered via a Respimat Soft Mist Inhaler (SMI) (Boehringer-Ingelheim, Germany) and SM + InspiraChamber (IC; InspiRx Inc, New Jersey, USA).
  
  
  RESULTS
  The two major outcomes were the acceptability of the treatment and the lung deposition (per cent of emitted dose).
  
  
  RESULTS
  All infants who fulfilled the inclusion criteria successfully received the SM treatment during sleep without difficulty. Mean lung deposition (±SD) averaged 1.6±0.5% in the right lung.
  
  
  CONCLUSIONS
  This study demonstrated that the combination of Respimat, IC and SM was able to administer aerosol therapy to all the sleeping infants who were regular pacifier users with good lung deposition. Administration of aerosols during sleep is advantageous since all the sleeping children accepted the mask and ensuing aerosol therapy under these conditions, in contrast to previous studies in which there was frequent mask rejection using currently available devices.
  
  
  BACKGROUND
  NCT01120938.
authors.affiliation: Pediatric Department, Ziv Medical Center, Faculty of Medicine, Bar-Ilan University, Safed, Israel.
authors.forename: Israel
authors.initials: I
authors.lastname: Amirav
authors.forename: Michael T
authors.initials: MT
authors.lastname: Newhouse
authors.forename: Anthony
authors.initials: A
authors.lastname: Luder
authors.forename: Asaf
authors.initials: A
authors.lastname: Halamish
authors.forename: Hamza
authors.initials: H
authors.lastname: Omar
authors.forename: Miguel
authors.initials: M
authors.lastname: Gorenberg
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D001249:Asthma / Q000188:drug therapy*; D016503:Drug Delivery Systems / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D008168:Lung; D008297:Male; D008397:Masks; D009330:Nebulizers and Vaporizers / Q000592:standards*; D010865:Pilot Projects; D011446:Prospective Studies; D012135:Respiratory Sounds; D012890:Sleep
chemical_list: D000336:Aerosols