Methoclopramide for Gastroesophageal Reflux in Premature Infants
Status:
Completed
Trial end date:
2019-01-31
Target enrollment:
Participant gender:
Summary
Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants
that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants
discharged with their mothers in continuous skin to skin contact and strict outpatient follow
up). For over 20 years, the use of Metoclopramide has been systematic among all preterm
infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of
this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen
the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC
Program before 40 weeks of gestational age. Design: Randomized, double blind trial,
controlled with placebo. Eligible Population: Premature infants that are followed and treated
in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before
40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg,
every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between
January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported
by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial
irritability, the infant rejects feeding, alteration in the postprandial posture and the
frequency and severity of adverse effects associated with the use of Metoclopramide such as
extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and
median will be compared according to the distribution and for nominal variables, a chi
squared test or fisher test will be carried out.
Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent
will be requested to parents. An independent committee from the work group will be in charge
of carrying out the follow-up of the safety and progression of the study. A methodological
expert, a thematic expert, a statistician and an expert in bioethics will constitute the
committee.
Financial Disclosure: The study will be funded through the Kangaroo Foundation with the
collaboration of the " Hospital Universitario San Ignacio", Bogotá, Colombia.
Phase:
Phase 4
Details
Lead Sponsor:
Nathalie Charpak
Collaborators:
Hospital Universitario San Ignacio Pontificia Universidad Javeriana