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

Gastroesophageal Reflux in Neonates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788485
• Other study ID #: PH-MII in neonates
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux in Neonates

Intervention

Drug:
• Diosmectite
use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates

Locations

Country	Name	City	State
Egypt	Ain Shams University-Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 7 days
Secondary	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.	within 24 hours