Gastroesophageal RefluxPhase 4NCT02907632
Methoclopramide for Gastroesophageal Reflux in Premature Infants
A Phase 4 study testing Metoclopramide in people with Gastroesophageal Reflux, run by Nathalie Charpak at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 100 days
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteColombia
- Study dates
- 26 Apr 2017to 31 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants followed at ambulatory Kangaroo Mother Care Program(KMCP) in Hospital San Ignacio, Bogotá, Colombia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Metoclopramide, Placebo
- Keywords
- Metoclopramide, Pro kinetic, Gastroesophageal Reflux, Premature Infant, Low Birth Weight, Kangaroo Mother Care Method
- Medical subject headings
- Gastroesophageal Reflux, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Plasil
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | Blind and randomized allocation to the experimental treatment: Metoclopramide Receives: Drug: Metoclopramide |
| Placebo | Placebo comparator | Blind and randomized allocation to placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of regurgitation episodes
Reported by the parents of the infants in a diary.
Measured: Until 40 weeks Post Menstrual Age
Secondary outcomes (5)
Episodes of apnea
Reported in clinical history
Measured: Until 40 weeks Post Menstrual Age
Bronchoaspiration
Reported in clinical history
Measured: Until 40 weeks Post Menstrual Age
Postprandial irritability
Reported by the parents of the infants in a diary
Measured: Until 40 weeks Post Menstrual Age
The infant rejects feeding
Reported by the parents of the infants in a diary
Measured: Until 40 weeks Post Menstrual Age
Alteration in the postprandial posture
Reported by the parents of the infants in a diary
Measured: Until 40 weeks Post Menstrual Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start26 Apr 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathalie Charpak
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Responsible party
- Sponsor-investigator, Nathalie Charpak, Kangaroo Foundation
- Investigators
- Nathalie Charpak, Dr., Study director, Kangaroo Foundation Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907632
- Sponsor's protocol ID
- 2015/71
- Status last verified
- Aug 2020
- First submitted
- 13 Sep 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16882832Tighe 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.
PubMed 19445547Montealegre-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.
PubMed 34693501
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02907632
- Acronym / sponsor ID
- 2015/71
- Conditions
- Gastroesophageal Reflux
- Keywords
- Metoclopramide, Pro kinetic, Gastroesophageal Reflux, Premature Infant, Low Birth Weight, Kangaroo Mother Care Method
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Nathalie CharpakUniversity, hospital or other
- Collaborators
- Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: MetoclopramideBlind and randomized allocation to the experimental treatment: Metoclopramide |
| Placebo | Placebo comparator | Drug: PlaceboBlind and randomized allocation to placebo |
Who may qualify
- Ages
- 1 day to 100 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants followed at ambulatory Kangaroo Mother Care Program(KMCP) in Hospital San Ignacio, Bogotá, Colombia.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramideAlso: PlasilMetoclopramide 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. | Drug | Metoclopramide |
| PlaceboOral 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. | Drug | Placebo |
Primary outcome
Incidence of regurgitation episodes
Time frame: Until 40 weeks Post Menstrual Age
Reported by the parents of the infants in a diary.
5 secondary outcomes
Episodes of apnea
Time frame: Until 40 weeks Post Menstrual Age
Bronchoaspiration
Time frame: Until 40 weeks Post Menstrual Age
Postprandial irritability
Time frame: Until 40 weeks Post Menstrual Age
The infant rejects feeding
Time frame: Until 40 weeks Post Menstrual Age
Alteration in the postprandial posture
Time frame: Until 40 weeks Post Menstrual Age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Results publication: PubMed 16882832Hibbs 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.
- Results publication: PubMed 19445547Tighe 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.
- Derived from this study: PubMed 34693501Montealegre-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Charpak, Dr. study director
Kangaroo Foundation Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide in people with Gastroesophageal Reflux, run by Nathalie Charpak at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of regurgitation episodes (time frame: Until 40 weeks Post Menstrual Age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907632, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.