Trial Outcomes & Findings for Safety Study of Airway Clearance Techniques in Infants. (NCT NCT02128867)
NCT ID: NCT02128867
Last Updated: 2015-03-17
Results Overview
number of refluxes will be counted over a period of 15 minutes ( treatment time )
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
15 minutes
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
Assisted Autogenic Drainage (AAD)
airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)
|
Bouncing Combined With AAD
airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD
|
Bouncing
bouncing as control group. intervention to relax the infant
bouncing
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
54
|
|
Overall Study
COMPLETED
|
50
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Airway Clearance Techniques in Infants.
Baseline characteristics by cohort
| Measure |
Assisted Autogenic Drainage (AAD)
n=50 Participants
airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)
|
Bouncing Combined With AAD
n=50 Participants
airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD
|
Bouncing
n=50 Participants
bouncing . intervention to relax the infant
bouncing
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 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
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 15 minutesnumber of refluxes will be counted over a period of 15 minutes ( treatment time )
Outcome measures
| Measure |
Assisted Autogenic Drainage (AAD)
n=50 Participants
airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD)
|
Bouncing Combined With AAD
n=50 Participants
airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD
|
Bouncing
n=50 Participants
bouncing as control group. intervention to relax the infant
bouncing
|
|---|---|---|---|
|
Number of Refluxes
|
0.48 number of refluxes
Standard Deviation 1.36
|
1.14 number of refluxes
Standard Deviation 2.55
|
1.62 number of refluxes
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 15 minutesduration of reflux episodes will be measured during 15 min of treatment time
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minutesheartrate will be measured during 15 min of treatment time
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minutesSaO2 will be measured during 15 minutes of treatment time
Outcome measures
Outcome data not reported
Adverse Events
Assisted Autogenic Drainage (AAD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bouncing Combined With AAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bouncing
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place