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

Ain Shams Maternity Hospital

Status and phase

Completed

Phase 4

Conditions

Gastroesophageal Reflux in Neonates

Treatments

Drug: Diosmectite

Study type

Interventional

Funder types

Other

Identifiers

NCT04788485

PH-MII in neonates

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

Under 30 days old

Volunteers

No Healthy Volunteers

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.