Gastro-oesophageal Reflux
Conditions
Brief summary
The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.
Interventions
20 min IPV freq 300/min, p 10cmH2O
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* infants from 0 to 12 months * impedance monitoring
Exclusion criteria
* gestational age \< 24w * anti-reflux medication * Nissen fundoplication * no parental consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Refluxes | during 20 minutes of IPV compared to mean number of refluxes during 20 minutes. | Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intrapulmonary Percussive Ventilation number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding
Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intrapulmonary Percussive Ventilation |
|---|---|
| Age, Categorical <=18 years | 50 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Gender Female | 25 Participants |
| Gender Male | 25 Participants |
| Region of Enrollment Belgium | 50 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Number of Refluxes
Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV
Time frame: during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
Population: All patients receiving IPV were their own controls
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapulmonary Percussive Ventilation | Number of Refluxes | 0.48 number of refluxes | Standard Deviation 0.76 |
| Control | Number of Refluxes | 0.97 number of refluxes | Standard Deviation 0.95 |