| Protocol ID | NCT03053388 |
| Registration Date | 2017-02-15 |
| Status | completed |
| Sponsor | Beyond Air Inc. |
| Country | Israel |
| Industry | industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2017-03-05 |
| Last Patient Out | 2018-04-28 |
| Publication | n |
| Gender % | ALL |
| Mean Age | - 12 Months |
NCT03053388
Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis
| Field |
GLM
glm-5.1 7970ms / 9558 tok |
OPENAI
gpt-4o 3808ms / 9409 tok |
CLAUDE
claude-sonnet-4-20250514 7859ms / 10947 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | respiratory | respiratory | respiratory | OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial does not measure symptoms directly or use validated symptom instruments; it focuses on hospital length of stay, clinical scores, and oxygen saturation.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study measures clinical improvement using Modified Tal score, oxygen saturation, and length of stay, but these are physiological/clinical parameters rather than specific symptom measures like pain, nausea, dyspnea, fatigue, anxiety, or depression.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome of measuring hospital Length of Stay (LOS) is a cost proxy.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures hospital length of stay (LOS) in hours, which is commonly used as a cost proxy in healthcare economic evaluations.
|
OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — Nitric oxide is an inhaled pharmacologic agent being investigated for its antimicrobial and bronchodilatory properties in bronchiolitis, which does not fit into the more specific subcategories like chemotherapy or controlled substances.
|
other
off label use → other
shaky reasoning✓ Unanimous
Initial: off label use
Requery: other — Nitric Oxide is used pharmacologically for its antimicrobial properties, but it does not fit into categories like controlled substances or off label use.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — Nitric oxide is a pharmacologic gas that has FDA approval for specific conditions like persistent pulmonary hypertension in newborns, but in this trial it's being evaluated for bronchiolitis which is not a standard approved indication, making it fall under the 'other' category for pharmacologic interventions.
|
OK |