Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance

Study Overview
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Brief Summary
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study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment

Detailed Description
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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

Official Title
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Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance

Conditions
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Gastroesophageal Reflux in Neonates

Intervention / Treatment
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* Drug: Diosmectite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Newborns free of any congenital anomalies or inborn errors of metabolism Infants had signs of reflux like: Typical or atypical crying and/or irritability Apparent life-threatening event Poor appetite; weight loss or poor growth (failure to thrive) Vomiting Bronchopulmonary dysplasia Wheezing, stridor Recurrent pneumonitis Sandifer syndrome (ie, posturing with opisthotonus or torticollis) Exclusion Criteria: • Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux. Patients with Hirshsprung disease or delayed passage of meconium. History of NEC in the baby.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neonates before adding smectite<br>neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph | Drug: Diosmectite<br>* use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates<br>* Other names: Smecta;|
| Active Comparator: neonates after adding smectite<br>neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph | Drug: Diosmectite<br>* use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates<br>* Other names: Smecta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |