Trial Outcomes & Findings for Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (NCT NCT04064684)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Between the time of enrollment and day 28 after enrollment

Results posted on

2022-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Budesonide Administered by Nebulizer Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Placebo Administered by Nebulizer Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Budesonide Administered by Nebulizer n=1 Participants Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Placebo Administered by Nebulizer n=1 Participants Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Total n=2 Participants Total of all reporting groups
Age, Continuous	6 months STANDARD_DEVIATION 0 • n=113 Participants	4 months STANDARD_DEVIATION 0 • n=163 Participants	5 months STANDARD_DEVIATION 1.4 • n=160 Participants
Sex: Female, Male Female	0 Participants n=113 Participants	1 Participants n=163 Participants	1 Participants n=160 Participants
Sex: Female, Male Male	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	1 Participants n=113 Participants	1 Participants n=163 Participants	2 Participants n=160 Participants
Race (NIH/OMB) White	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment United States	1 participants n=113 Participants	1 participants n=163 Participants	2 participants n=160 Participants

PRIMARY outcome

Timeframe: Between the time of enrollment and day 28 after enrollment

Outcome measures

Outcome measures
Measure	Budesonide Administered by Nebulizer n=1 Participants Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Placebo Administered by Nebulizer n=1 Participants Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
Number of Ventilator-free Days (VFD)	20 days	17 days

SECONDARY outcome

Timeframe: Day one to last day of last day of mechanical ventilation (up to 10 days)

Population: For the participant in the budesonide arm, data for this outcome measure was not collected on days 9 and 10.

Oxygenation index (OI) is calculated as (\[FiO2 x Mean Airway Pressure\] / PaO2). FiO2 stands for inspired fraction of oxygen, and PaO2 stands for pressure/arterial pressure of oxygen. An oxygenation index of 4-8 indicates mild ARDS, an oxygenation index of 8-16 indicates moderate ARDS, and an oxygenation index greater than 16 indicates severe ARDS.

Outcome measures

Outcome measures
Measure	Budesonide Administered by Nebulizer n=1 Participants Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Placebo Administered by Nebulizer n=1 Participants Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
Oxygenation Index (OI) day 4	4 index Standard Deviation 0	6.4 index Standard Deviation 0
Oxygenation Index (OI) day 5	3.2 index Standard Deviation 0	14.4 index Standard Deviation 0
Oxygenation Index (OI) day 1	11 index Standard Deviation 0	12 index Standard Deviation 0
Oxygenation Index (OI) day 2	11 index Standard Deviation 0	8 index Standard Deviation 0
Oxygenation Index (OI) day 3	8 index Standard Deviation 0	11.4 index Standard Deviation 0
Oxygenation Index (OI) day 6	3.5 index Standard Deviation 0	11.5 index Standard Deviation 0
Oxygenation Index (OI) day 7	5 index Standard Deviation 0	10 index Standard Deviation 0
Oxygenation Index (OI) day 8	2.8 index Standard Deviation 0	8.7 index Standard Deviation 0
Oxygenation Index (OI) day 9	—	5 index Standard Deviation 0
Oxygenation Index (OI) day 10	—	5 index Standard Deviation 0

SECONDARY outcome

Timeframe: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment

Population: Data for this outcome measure were not collected for either participant.

5-7.5 mild ARDS, 7.5-12.3 moderate ARDS. \> 12.3 severe ARDS, formula FiO2\*Mean airway pressure/Saturation of O2 Oxygen saturation index (OI) is calculated as (\[FiO2 x Mean Airway Pressure\] / Saturation of oxygen). FiO2 stands for inspired fraction of oxygen. An oxygen saturation index of 5-7.5 indicates mild ARDS, an oxygen saturation index of 7.5-12.3 indicates moderate ARDS, and an oxygen saturation index greater than 12.3 indicates severe ARDS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)

Outcome measures

Outcome measures
Measure	Budesonide Administered by Nebulizer n=1 Participants Budesonide: Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.	Placebo Administered by Nebulizer n=1 Participants Placebo: Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days. Nebulizer: The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)	46 days	17 days

SECONDARY outcome

Timeframe: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)