Trial Outcomes & Findings for The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis. (NCT NCT02126748)

Results Overview

Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

6 days

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intrapulmonary Percussive Ventilation 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Intrapulmonary Percussive Ventilation	Assisted Autogenic Drainage 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Assisted Autogenic Drainage	Control 20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Overall Study STARTED	33	34	36
Overall Study COMPLETED	31	31	31
Overall Study NOT COMPLETED	2	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrapulmonary Percussive Ventilation n=31 Participants 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day	Assisted Autogenic Drainage n=31 Participants 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day	Control n=31 Participants 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day	Total n=93 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	31 Participants n=7 Participants	31 Participants n=5 Participants	93 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment Belgium	31 participants n=5 Participants	31 participants n=7 Participants	31 participants n=5 Participants	93 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 days

Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)

Outcome measures

Outcome measures
Measure	Intrapulmonary Percussive Ventilation n=31 Participants 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Intrapulmonary Percussive Ventilation	Assisted Autogenic Drainage n=31 Participants 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Assisted Autogenic Drainage	Control n=31 Participants 20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
Length of Hospital Stay	3.5 days Standard Deviation 1.3	3.6 days Standard Deviation 1.4	4.5 days Standard Deviation 1.9

SECONDARY outcome

Timeframe: before treatment, immediately after treatment and 1h after treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before, after and 1h after intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before, after and 1h after treatment

oxygen saturation (SaO2) measured by pulse -oximetry

Outcome measures

Outcome data not reported

Adverse Events

Intrapulmonary Percussive Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Assisted Autogenic Drainage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Filip Van Ginderdeuren

Vrije Universiteit Brussel

Phone: +3224763916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place