Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
Status:
Completed
Trial end date:
2020-04-02
Target enrollment:
Participant gender:
Summary
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of
Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
The proposed study judiciously expands these observations for use of NO treatment in
pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing
strategy used in this study has been selected to minimize the potential for adverse effects.
The inclusion of two doses in the proposed pilot study is intended to determine a dose
response effect and select a dose that is optimally safe and effective. The primary endpoint
evaluation of time to fit for discharge will provide an effective objective measurement for
the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
Primary objective:
• Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via
inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to
Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis,
compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment
therapy as measured by Adverse Events (AE) - number and percentage of subjects that
experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to
receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and
un-blinded team members.The blinded staff will be performing the study assessment procedures
and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5
and 30+5 from the date of enrollment of the subject into the study.