Methoclopramide for Gastroesophageal Reflux in Premature Infants

PHASE4CompletedINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

April 26, 2017

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
Gastroesophageal Reflux
Interventions
DRUG

Metoclopramide

"Metoclopramide Solution 4 mg / ml; 30 ml canister (1 drop equals 0.2 mg). Dose: 0.2 mg / kg / dose (1 drop per kg) every 8 hours orally 15 minutes before lactation.~Duration: Until the child completes 40 weeks of post menstrual age."

DRUG

Placebo

Oral solution: 1 drop per kg of placebo 15 minutes before lactation with identical presentation appearance, taste and color than Metoclopramide. Duration: Until the child completes 40 weeks of post menstrual age.

Trial Locations (1)

110231

Nathalie Charpak, Bogotá

All Listed Sponsors
collaborator

Hospital Universitario San Ignacio

OTHER

collaborator

Pontificia Universidad Javeriana

OTHER

lead

Nathalie Charpak

OTHER

NCT02907632 - Methoclopramide for Gastroesophageal Reflux in Premature Infants | Biotech Hunter | Biotech Hunter