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study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
This is a prospective clinical trial conducted on 20 preterm neonates < 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates before adding smectite | Active Comparator | neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph |
|
| neonates after adding smectite | Active Comparator | neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmectite | Drug | use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates | efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring. | within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH | determine the reliability of signs such as cardio-respiratory events, apneas and dystonic neck posturing (Sandifer syndrome) in the diagnosis of GERD using Multichannel intraluminal impedance-pH monitoring. | within 24 hours |
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Inclusion Criteria:
• Newborns free of any congenital anomalies or inborn errors of metabolism
Infants had signs of reflux like:
Exclusion Criteria:
• Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University-Faculty of Medicine | Cairo | 11591 | Egypt |
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|
| ID | Term |
|---|---|
| C033214 | Smectite |
| C016752 | smecta |
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