A Phase 4 interventional study of Diosmectite in Gastroesophageal Reflux in Neonates, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to participants aged 0 Days to 30 Days. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Ain Shams Maternity Hospital · Phase 4, Interventional, and Treatment
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
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
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newborns free of any congenital anomalies or inborn errors of metabolism
Infants had signs of reflux like:
Exclusion Criteria:
Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.
neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph
Drug: Diosmectite
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
Also known as: Smecta
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.
Time frame: within 7 days
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.
Time frame: within 24 hours
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ain Shams Maternity Hospital