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Trial record 2 of 10 for:    infant | Recruiting, Not yet recruiting, Available Studies | gerd

Methoclopramide for Gastroesophageal Reflux in Premature Infants

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ClinicalTrials.gov Identifier: NCT02907632
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Information provided by (Responsible Party):
Nathalie Charpak, Kangaroo Foundation

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.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Metoclopramide Drug: Placebo Phase 4

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 January 01 2017 and December 31 2017. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Metoclopramide for the Prevention of Gastroesophageal Reflux in Premature Infants Followed in an Outpatient Kangaroo Mother Care Clinic Before 40 Weeks of Gestational Age: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metoclopramide
Blind and randomized allocation to the experimental treatment: Metoclopramide
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.

Other Name: Plasil
Placebo Comparator: Placebo
Blind and randomized allocation to placebo
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.



Primary Outcome Measures :
  1. Incidence of regurgitation episodes [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported by the parents of the infants in a diary.


Secondary Outcome Measures :
  1. Episodes of apnea [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported in clinical history

  2. Bronchoaspiration [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported in clinical history

  3. Postprandial irritability [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported by the parents of the infants in a diary

  4. The infant rejects feeding [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported by the parents of the infants in a diary

  5. Alteration in the postprandial posture [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported by the parents of the infants in a diary


Other Outcome Measures:
  1. extrapyramidal symptoms [ Time Frame: Until 40 weeks Post Menstrual Age ]
    Reported in clinical history



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907632


Contacts
Contact: Nathalie Charpak, Dr. (571)3002116552 ncharpak@gmail.com
Contact: Adriana Montealegre, Dr. (571)3156701641 montealegrepomar@gmail.com

Locations
Colombia
Nathalie Charpak Recruiting
Bogotá, Cundinamarca, Colombia, 110231
Contact: Nathalie Charpak, Dr    573002116552    ncharpak@gmail.com   
Contact: Nathalie Charpak, Dr.       ncharpak@gmail.com   
Sponsors and Collaborators
Nathalie Charpak
Hospital Universitario San Ignacio
Pontificia Universidad Javeriana
Investigators
Study Director: Nathalie Charpak, Dr. Kangaroo Foundation Director

Publications of Results:
Responsible Party: Nathalie Charpak, Doctor, Kangaroo Foundation
ClinicalTrials.gov Identifier: NCT02907632     History of Changes
Other Study ID Numbers: 2015/71
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nathalie Charpak, Kangaroo Foundation:
Metoclopramide
Pro kinetic
Gastroesophageal Reflux
Premature Infant
Low Birth Weight
Kangaroo Mother Care Method

Additional relevant MeSH terms:
Gastroesophageal Reflux
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action