Uncomplicated oesophageal reflux, infants 2-6 months, oesophageal pH monitoring
Conditions
Interventions
The included infants will be, based on study entry number, at random allocated to one of three study infant formulae. These products have the same basic composition, but differ in amount and type (hot
Sponsors
Saint Marina Hospital, Varna, Bulgaria
Eligibility
Inclusion criteria
Inclusion criteria: 1) 2-6 months of age with a score of I-GERQ more than 7, as defined by Orenstein. 2) Proven acid or non-acid reflux with pH-Z ambulatory 24-hour pH and impedance recorder 3) The signed informed consent by one/both parents / legal guardian 4) Available throughout the study period 5) Parents/guardian have the mental ability to understand and willingness to fulfil all the details of the protocol
Exclusion criteria
Exclusion criteria: 1) Preferred no breastfeeding at time of inclusion. When the inclusion of participants in not possible because of this criteria, 25% breast milk of total daily milk intake is allowed. 2) Cow’s milk protein allergy diagnosed as positive IgE and/or positive prick reactions to cow’s milk and/or eosinophilia in differential blood count, 3) Preterm birth, 4) Infants with a history of wheezing, aspiration pneumonia, apnea. 5) Anemia with hemoglobin less than 90g/l, as checked by finger prick. 6) Gastro-intestinal bleeding, diarrhoea 7) Infants with laryngitis, 8) Urinary tract infection 9) Weight gain for the last month of more than 100 g/week 10) Apparent life threatening events, 11) Neurologic deficits, 12) Infants with a known organic or metabolic cause of reflux, 13) Infants already receiving anti-reflux formulae or medications that can affect gastrointestinal tract motility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Components of 24-h Oesophageal pH Monitoring using a Digitrapper pH-Z ambulatory 24-hour pH and impedance recorder: • Percent total time pH < 4 • Percent Upright time pH < 4 • Percent Supine time pH < 4 • Number of reflux episodes • Number of reflux episodes ≥ 5 min • Longest reflux episode (minutes) • SI (symptom index for reflux) • SSI (symptom sensitivity index) • SAP (symptom associated probability) | — |
Secondary
| Measure | Time frame |
|---|---|
| The nuimber of visible refluxes and stool consistency as monitored by the parent using a 3-days diary. | — |
Contacts
Public ContactAnne Schaafsma
P.O.Box 226
Outcome results
None listed