Gastro-esophageal Reflux
Conditions
Keywords
gastro-esophageal reflux, GOR, GER, airway clearance techniques
Brief summary
The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.
Interventions
OTHERAssisted Autogenic Drainage (AAD)
OTHERbouncing and AAD
OTHERbouncing
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 365 Days
Healthy volunteers
Yes
Inclusion criteria
* infants \< 1 year * acid reflux monitoring
Exclusion criteria
* gestational age \<24 w * anti-reflux medication * Nissen fundoplication * no parental consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Refluxes | 15 minutes | number of refluxes will be counted over a period of 15 minutes ( treatment time ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Reflux Episodes | 15 minutes | duration of reflux episodes will be measured during 15 min of treatment time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heartrate | 15 minutes | heartrate will be measured during 15 min of treatment time |
| Sa02 | 15 minutes | SaO2 will be measured during 15 minutes of treatment time |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assisted Autogenic Drainage (AAD) airway clearance technique for infants :Assisted Autogenic Drainage
Assisted Autogenic Drainage (AAD) | 50 |
| Bouncing Combined With AAD airway clearance technique for infants : bouncing combined with AAD
bouncing combined with AAD | 50 |
| Bouncing bouncing . intervention to relax the infant
bouncing | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | Assisted Autogenic Drainage (AAD) | Bouncing Combined With AAD | Bouncing | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 22 Participants | 69 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 28 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 0 / 52 | 0 / 54 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 | 0 / 54 |
Outcome results
Primary
Number of Refluxes
number of refluxes will be counted over a period of 15 minutes ( treatment time )
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Autogenic Drainage (AAD) | Number of Refluxes | 0.48 number of refluxes | Standard Deviation 1.36 |
| Bouncing Combined With AAD | Number of Refluxes | 1.14 number of refluxes | Standard Deviation 2.55 |
| Bouncing | Number of Refluxes | 1.62 number of refluxes | Standard Deviation 3.8 |
Secondary
Duration of Reflux Episodes
duration of reflux episodes will be measured during 15 min of treatment time
Time frame: 15 minutes
Other Pre-specified
Heartrate
heartrate will be measured during 15 min of treatment time
Time frame: 15 minutes
Other Pre-specified
Sa02
SaO2 will be measured during 15 minutes of treatment time
Time frame: 15 minutes