NCT01858584

Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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 antagonist(H2RA) 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 (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.

Conditions

• Gastroesophageal Reflux
• Regurgitation
• Vomiting
• Chronic Cough

Interventions

Type	Name	Description
DRUG	Gastrotuss	Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water. dosage: * Infants weighing \<5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional * Infants weighing\> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day
DIETARY_SUPPLEMENT	thickened milk	Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• First posted: 2013-05-21
• Last updated: 2013-05-30

Locations

1 site across 1 country: Italy