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Completed

NCT Number: NCT04788485

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

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

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Key information

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University-Faculty of Medicine

Cairo, 11591, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diosmectite

Drug

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

Other names: Smecta

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2021
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.