Gastro-oesophageal Reflux
Conditions
Brief summary
The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to the hospital for impedance-pH monitoring are included in this study.
Interventions
OTHERAAD
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
OTHERBAAD
In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data will be analyzed by an experienced paediatric gastro-enterologist, blinded to the different treatment modalities
Eligibility
Sex/Gender
ALL
Age
1 Days to 365 Days
Healthy volunteers
No
Inclusion criteria
* Each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological GOR will be included
Exclusion criteria
* prematurity (gestational age less than 37 weeks), * the use of anti-reflux medication and reflux surgery (Nissen fundoplication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of refluxes | 20 minutes |
Secondary
| Measure | Time frame |
|---|---|
| number of acid refluxes | 20 minutes |
Other
| Measure | Time frame |
|---|---|
| number of non-acid refluxes | 20 minutes |
Countries
Belgium
Outcome results
None listed