Recruitment

Recruitment Status
Unknown status

Summary

Conditions
  • Chronic Cough
  • Gastroesophageal Reflux
  • Regurgitation
  • Vomiting
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Max Age
12
Gender
Both

Description

Primary outcomes This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from gastroesophageal reflux (GER) the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativi...

Primary outcomes This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from gastroesophageal reflux (GER) the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of GER (I-GERQ Annex A). Secondary outcomes To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance, basing on questionnaire results.

Locations

Naples, 80131
Naples, 80131

Tracking Information

NCT #
NCT01858584
Collaborators
Not Provided
Investigators
  • Principal Investigator: Annamaria Staiano Federico II University
  • Annamaria Staiano Federico II University