Status:
COMPLETED
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Lead Sponsor:
Ain Shams Maternity Hospital
Conditions:
Gastroesophageal Reflux in Neonates
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE4
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 refl...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04788485
Start Date
September 1 2017
End Date
March 1 2021
Last Update
March 11 2021
Active Locations (1)
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1
Ain Shams University-Faculty of Medicine
Cairo, Egypt, 11591