Methoclopramide for Gastroesophageal Reflux in Premature Infants

NCT02907632 | Completed Phase 4 DMC

• 1 other identifier: 2015/71
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux

Keywords

Metoclopramide; Pro kinetic; Gastroesophageal Reflux; Premature Infant; Low Birth Weight; Kangaroo Mother Care Method

Outcome Measures

Primary Outcomes (1)

• Incidence of regurgitation episodes

  Reported by the parents of the infants in a diary.

  Until 40 weeks Post Menstrual Age

Secondary Outcomes (5)

• Episodes of apnea

  Until 40 weeks Post Menstrual Age

• Bronchoaspiration

  Until 40 weeks Post Menstrual Age

• Postprandial irritability

  Until 40 weeks Post Menstrual Age

• The infant rejects feeding

  Until 40 weeks Post Menstrual Age

• Alteration in the postprandial posture

  Until 40 weeks Post Menstrual Age

Other Outcomes (1)

• extrapyramidal symptoms

  Until 40 weeks Post Menstrual Age

Study Arms (2)

Metoclopramide

EXPERIMENTAL

Blind and randomized allocation to the experimental treatment: Metoclopramide

Drug: Metoclopramide

Placebo

PLACEBO COMPARATOR

Blind and randomized allocation to placebo

Drug: Placebo

Interventions

Metoclopramide DRUG

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.

Also known as: Plasil

Metoclopramide

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 1 Day - 100 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants followed at ambulatory Kangaroo Mother Care Program(KMCP) in Hospital San Ignacio, Bogotá, Colombia.

You may not qualify if:

• Hipoxic- Ischemic Encephalopathy. Periventricular Leukomalacia (PVL). Intraventricular hemorrhage grade 3 or 4. Severe dystonia Seizures. Liver failure. Renal insufficiency. Previous adverse events with the use of Metoclopramide. Parents don´t agree participation.

Sponsors & Collaborators

• Nathalie Charpak: lead
• Hospital Universitario San Ignacio: collaborator
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Nathalie Charpak

Bogotá, Cundinamarca, 110231, Colombia

Location

Related Publications (3)

• Hibbs AM, Lorch SA. Metoclopramide for the treatment of gastroesophageal reflux disease in infants: a systematic review. Pediatrics. 2006 Aug;118(2):746-52. doi: 10.1542/peds.2005-2664.

  PMID: 16882832 RESULT

• Tighe MP, Afzal NA, Bevan A, Beattie RM. Current pharmacological management of gastro-esophageal reflux in children: an evidence-based systematic review. Paediatr Drugs. 2009;11(3):185-202. doi: 10.2165/00148581-200911030-00004.

  PMID: 19445547 RESULT

• Montealegre-Pomar ADP, Charpak N. Randomized Clinical Trial of Metoclopramide as Prophylaxis of Gastroesophageal Reflux Disease in Preterm Infants. Paediatr Drugs. 2021 Nov;23(6):591-599. doi: 10.1007/s40272-021-00475-x. Epub 2021 Oct 25.

  PMID: 34693501 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Premature Birth

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Nathalie Charpak, Dr.

  Kangaroo Foundation Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 20, 2016
• Study Start: April 26, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)