Methoclopramide for Gastroesophageal Reflux in Premature Infants
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Premature Birth
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Justification: Gastroesophageal Reflux (GER) is a condition that affects the majority of
      premature infants that are followed at the Kangaroo Mother Care Program. The incidence of GRE
      in premature infants can oscillate between 22 and 85% depending on the criteria used to
      diagnose GER, which can vary among healthcare professionals.

      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. These protocols were
      established according to the recommendations emitted by the Cochrane Collaboration in 2006,
      nevertheless according to new studies published in the last years, the controversial evidence
      referring the use of metoclopramide given the eventual possibility of adverse effects and the
      lack of evidence in premature infants, it is necessary to evaluate whether it is pertinent to
      continue the use of metoclopramide in premature infants and the risk of adverse effects.

      Objective: 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 KMC 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 April 1 2017 and January 31 2019. Intervention: Blind and
      randomized allocation to the experimental treatment (metoclopramide 0.2 mg per kg, every 8
      hours, 15 minutes before every feeding up to 40 weeks of gestational age) or placebo.

      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.Intervention: Blind and randomized allocation to the experimental treatment
      (metoclopramide 0.2 mg per kg, every 8 hours, 15 minutes before every feeding up to 40 weeks
      of gestational age) or placebo.

      Expected Results: Reliable information regarding the use of metoclopramide in premature
      infants for the prevention of regurgitation episodes associated to apnea, cyanosis,
      irritability, rejection of feeding efforts, bronchoaspiration and poor weight gain as well as
      adverse effects.

      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", Bogota, Colombia.
    

Intervention name(s): Metoclopramide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Plasil
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metoclopramide; Pro kinetic; Gastroesophageal Reflux; Premature Infant; Low Birth Weight; Kangaroo Mother Care Method