search
Back to results

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

Primary Purpose

Gastroesophageal Reflux in Neonates

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Diosmectite
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux in Neonates

Eligibility Criteria

0 Days - 30 Days (Child)All SexesDoes not accept 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.

Sites / Locations

  • Ain Shams University-Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neonates before adding smectite

neonates after adding smectite

Arm Description

neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph

neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 5, 2021
Last Updated
March 9, 2021
Sponsor
Ain Shams Maternity Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04788485
Brief Title
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Official Title
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux in Neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neonates before adding smectite
Arm Type
Active Comparator
Arm Description
neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
Arm Title
neonates after adding smectite
Arm Type
Active Comparator
Arm Description
neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
Intervention Type
Drug
Intervention Name(s)
Diosmectite
Other Intervention Name(s)
Smecta
Intervention Description
use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
Primary Outcome Measure Information:
Title
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
Description
efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring.
Time Frame
within 7 days
Secondary Outcome Measure Information:
Title
Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University-Faculty of Medicine
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs