Ignite Creation Date:
2024-05-06 @ 1:36 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01858584
Status:
UNKNOWN
Last Update Posted:
2013-05-30
First Post:
2013-05-17
Brief Title:
Prospective Comparative Randomized Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Prospective Comparative Randomized Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The results on the efficacy of the formulations based on alginic acid are controversial Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux GER and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonistH2RA and proton pump inhibitor PPI
Detailed 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 negativity of the symptom score 431 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None