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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04788485

Enrollment

Registered

2021-03-09

Start date

2017-09-01

Completion date

2021-03-01

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux in Neonates

Brief summary

study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment

Detailed description

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

Interventions

DRUGDiosmectite

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

0 Days to 30 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates	within 7 days	efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring.

Secondary

Measure	Time frame	Description
Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH	within 24 hours	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026