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

Ain Shams Maternity Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastroesophageal Reflux in Neonates

Interventions

DiosmectiteDRUG

use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates

Eligibility

Sex: ALLMin age: 0 DaysMax age: 30 Days

Medical Language ↔ Plain English

Inclusion Criteria: * • Newborns free of any congenital anomalies or inborn errors of metabolism * Infants had signs of reflux like: 1. Typical or atypical crying and/or irritability 2. Apparent life-threatening event 3. Poor appetite; weight loss or poor growth (failure to thrive) 4. Vomiting 5. Bronchopulmonary dysplasia 6. Wheezing, stridor 7. Recurrent pneumonitis 8. 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.

Locations (1)

Ain Shams University-Faculty of Medicine

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: within 7 days

Secondary Outcomes

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.

Time frame: within 24 hours

Data from ClinicalTrials.gov

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