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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-03-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Gastroesophageal Reflux in Neonates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Neonates before adding smectite

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

Group Type ACTIVE_COMPARATOR

Diosmectite

Intervention Type DRUG

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

neonates after adding smectite

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

Group Type ACTIVE_COMPARATOR

Diosmectite

Intervention Type DRUG

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

Interventions

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Diosmectite

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

Intervention Type DRUG

Other Intervention Names

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Smecta

Eligibility Criteria

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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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No