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

Phase 4

Completed

• Conditions: Gastroesophageal Reflux in Neonates
• Interventions: Drug: Diosmectite

• Registration Number: NCT04788485
• Lead Sponsor: Ain Shams Maternity Hospital

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

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2021-02-25
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neonates before adding smectite	Diosmectite	neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
neonates after adding smectite	Diosmectite	neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ain Shams University-Faculty of Medicine; 🇪🇬 Cairo, Egypt