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Feasibility of Aerosol Drug Delivery to Sleeping Infants: A Prospective Observational Study — Amirav I et al1

Background:
  • Delivery of inhaled medications to infants may be very challenging due to crying and mask rejection
  • It has been suggested that aerosol administration during sleep may be less frightening for the child
  • Previous studies with current masks proved disappointing since most awoke and rejected the mask
Methods:
  • Infants ages <12 months (N=13) were given normal saline aerosol (99m Tc) placebo generated by a Respimat® pMDI
  • Aerosol delivery system consisted of SootherMaskTM attached to an InspiraChamber® VHC
  • Both right lung and total lung aerosol deposition were quantified scintigraphically. First, the child’s pacifier + SootherMask were given to and accepted by the child, and the child fell asleep; then the pMDI + VHC were gently mated to the SootherMask
  • Two successive ‘puffs’ from the pMDI were fired into the VHC; the mask was kept on the infant’s face for one minute; scintiscans (anterior/posterior for 60 seconds) followed each treatment
  • Aerosol deposition in each area was expressed as a percent of total radioactivity emitted at the pMDI mouthpiece
Results:
  • Ten of 13 initially enrolled infants completed the study
  • Reasons for non-completion were: one infant did not fall asleep during observation period; one infant awoke/excessive movement prevented image acquisition; one infant had a respiratory illness requiring exclusion from study evaluation
  • Characteristic scintigraph: green circle denotes the stomach, red circle denotes upper airways, solid yellow denotes the right lung
  • Children accepted SootherMask with their own pacifiers prior to connecting it to the VHC
  • Aerosol administration using SootherMask in sleeping infants, inhaling through the nose, achieved potentially ‘therapeutic’ lung deposition
    • Aerosol delivery: Mean percent (±SD) of total emitted dose, averaged 1.6±0.5% in the right lung, indicating good lung deposition
Scintigraph From Study Demonstrating Aerosol Deposition1
Average Aerosol Deposition (%) With SootherMask in a Clinical Study (N=10)1
Right Lung (YELLOW) Both Lungs Stomach (GREEN) Upper Airway (RED)
1.61 ± 0.56 4.17 ± 1.27 1.42 ± 0.97 16.75 ± 7.81
  • All infants readily accepted the SootherMask and did not awaken, cry or demonstrate fear of the mask or the aerosol therapy

Study Conclusion: SootherMask achieved potentially ‘therapeutic’ lung deposition in sleeping children inhaling through the nose


 
  INSPIRACHAMBER, INSPIRAMASK and SOOTHERMASK are registered to InspiRx, Inc.
INDICATIONS FOR USE

InspiraChamber Anti-Static Valved Holding Chamber (VHC) is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The intended environments are the home, hospitals and clinics.

Cautions:
  • Do not leave InspiraChamber, SootherMask or InspiraMask unattended with children.
Notes:
  • Storage and operating range: 5°C–40°C (41°F–104°F) at 15–95% relative humidity.
  • Inspect the device for cracks, debris, or damage that will prevent proper function after each cleaning. REPLACE IMMEDIATELY if any damages are observed. Environmental conditions, storage and proper cleaning can affect device life span.
  • This medical device is for single-patient use.
  • The intended patient population for InspiraChamber with Mouthpiece is three (3) years and older who have been prescribed pMDI medications.
  • The size of the SootherMask or InspiraMask should be determined by the size of the patient’s face.
  • If medication build-up is observed in your chamber, wash the inside of the chamber with a soft cloth according to the Instructions for Use to ensure proper performance.