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

March 9, 2021 updated by: Hend Fayez Ahmed, Ain Shams Maternity Hospital
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain Shams University-Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Neonates before adding smectite
neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
Drug: Diosmectite
use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
Other Names:
  • Smecta
ACTIVE_COMPARATOR: neonates after adding smectite
neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
Drug: Diosmectite
use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
Other Names:
  • Smecta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
Time Frame: within 7 days
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
Time Frame: 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.
within 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

February 25, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (ACTUAL)

March 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-MII in neonates

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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