Methoclopramide for Gastroesophageal Reflux in Premature Infants

Sponsor

Nathalie Charpak (Other)

Overall Status

Completed

CT.gov ID

NCT02907632

Collaborator

Hospital Universitario San Ignacio (Other), Pontificia Universidad Javeriana (Other)

490

Enrollment

Location

Arms

21.2

Actual Duration (Months)

23.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Financial Disclosure: The study will be funded through the Kangaroo Foundation with the collaboration of the " Hospital Universitario San Ignacio", Bogota, Colombia.

Study Design

Study Type:

Interventional

Actual Enrollment :

490 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 :

Apr 26, 2017

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Incidence of regurgitation episodes [Until 40 weeks Post Menstrual Age]
Reported by the parents of the infants in a diary.

Secondary Outcome Measures

Episodes of apnea [Until 40 weeks Post Menstrual Age]
Reported in clinical history
Bronchoaspiration [Until 40 weeks Post Menstrual Age]
Reported in clinical history
Postprandial irritability [Until 40 weeks Post Menstrual Age]
Reported by the parents of the infants in a diary
The infant rejects feeding [Until 40 weeks Post Menstrual Age]
Reported by the parents of the infants in a diary
Alteration in the postprandial posture [Until 40 weeks Post Menstrual Age]
Reported by the parents of the infants in a diary

Other Outcome Measures

extrapyramidal symptoms [Until 40 weeks Post Menstrual Age]
Reported in clinical history

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 100 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.