GastroschisisPhase 3NCT02098915
Metoclopramide Pilot Trial
A Phase 3 study testing intravenous metoclopramide in people with Gastroschisis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Infants with gastroschisis typically have poor intestinal motility for the first weeks to months after birth. Prokinetic agents are often used in these infants to improve intestinal motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to support this practice remains weak. Read more about this study
- Who is it for?
- Ages 33 weeks and older
- Conditions the study is for
- Gastroschisis
- What is being tested?
- intravenous metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to 12 Dec 2019
- Phase
- Phase 3
- 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 33 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure)
- Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment
Who cannot join
- Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility)
- Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis)
- Gestational age <32 weeks
- Birth weight < 1500 gm
- Received an investigational product within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
Infants with gastroschisis typically have poor intestinal motility for the first weeks to months after birth. Prokinetic agents are often used in these infants to improve intestinal motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to support this practice remains weak. Investigators hypothesize that a prokinetic agent given intravenously (infused into a vein) may be effective in improving gut motility in children with gastroschisis.
Read the detailed description
The research question will be addressed in a pilot randomized double-blind placebo controlled clinical trial evaluating the efficacy of metoclopramide.Investigators will recruit 30 neonates (15 per arm) diagnosed with gastroschisis. There will be two arms to the trial: the experimental arm will receive intravenous metoclopramide and the control arm will receive placebo. Patients will receive prokinetic agent therapy, dosed according to weight, or placebo. Each subject will receive the intervention for 28 days or until achievement of full enteral feeding, whichever comes first. Primary outcome: Days to achieve full enteral feeding when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth. Secondary outcomes: 1. Duration (days) until initiation of enteral feeds. 2. Duration (days) on parenteral nutrition. 3. Weight gain, measured by grams per day per week during therapy. 4. Occurrence of adverse effects associated with the use of metoclopramide. 5. Rate of catheter-related sepsis episodes (line positive blood cultures necessitating antibiotic treatment or catheter removal). 6. Incidence of necrotizing enterocolitis (NEC) based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray. 7. Duration of hospitalization (number of days from admission until final hospital discharge).
Subjects can be withdrawn from the study if meet one of the following criteria:
- Subject develops extrapyramidal symptoms
- Subject has not established full enteral feeding by the end of day 28 of therapy
- Withdrawal of informed consent or refusal of further study participation by parent/legal guardian
- Serious adverse event which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Any clinical adverse event, laboratory abnormality or intercurrent illness which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Unpredictable discontinuation of metoclopramide drug supply
- Conditions
- Gastroschisis
- Being tested
- intravenous metoclopramide, Placebo
- Keywords
- gastroschisis, intestinal motility, prokinetic agents, intravenous metoclopramide, time to full enteral feeding
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous metoclopramideDrug
the experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age
PlaceboOther
equivalent volume to intravenous metoclopramide (dosed according to the current Sick Kids guidelines based upon weight and age ) of sterile sodium chloride 0.9% injection as a placebo
| Study group | Role | What they receive |
|---|---|---|
| intravenous metoclopramide | Experimental | the experimental arm will receive intravenous metoclopramide Receives: Drug: intravenous metoclopramide |
| control arm | Placebo comparator | the control arm will receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to achieve full enteral feeding
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Days to achieve full enteral feeding will be recorded when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (7)
Duration until initiation of enteral feeds
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) until initiation of enteral feeds will be recorded
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Duration on parenteral nutrition
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) on parenteral nutrition will be recorded
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Weight gain
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Weight gain, measured by grams per day per week during therapy will be recorded
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Occurrence of adverse effects
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Occurrence of adverse effects associated with the use of metoclopramide will be recorded.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Rate of catheter-related sepsis episodes
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Rate of catheter-related sepsis episodes during intravenous treatment (line positive blood cultures necessitating antibiotic treatment or catheter removal) will be recorded.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Incidence of necrotizing enterocolitis (NEC) during the therapy based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray will be recorded.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Duration of hospitalization
Duration of hospitalization (number of days from admission until final hospital discharge) will be recorded.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Why it stopped: Decision to prematurely close the trial was made because of poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Jacob Langer, The Hospital for Sick Children
- Investigators
- Jacob C Langer, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098915
- Sponsor's protocol ID
- 1000038585
- Other IDs
- 169334
- Status last verified
- Dec 2019
- First submitted
- 21 Mar 2014
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02098915
- Acronym / sponsor ID
- 1000038585
- Conditions
- Gastroschisis
- Keywords
- gastroschisis, intestinal motility, prokinetic agents, intravenous metoclopramide, time to full enteral feeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to prematurely close the trial was made because of poor recruitment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2014
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 28 Mar 2014 (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.
Infants with gastroschisis typically have poor intestinal motility for the first weeks to months after birth. Prokinetic agents are often used in these infants to improve intestinal motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to support this practice remains weak. Investigators hypothesize that a prokinetic agent given intravenously (infused into a vein) may be effective in improving gut motility in children with gastroschisis.
Detailed description
The research question will be addressed in a pilot randomized double-blind placebo controlled clinical trial evaluating the efficacy of metoclopramide.Investigators will recruit 30 neonates (15 per arm) diagnosed with gastroschisis. There will be two arms to the trial: the experimental arm will receive intravenous metoclopramide and the control arm will receive placebo. Patients will receive prokinetic agent therapy, dosed according to weight, or placebo. Each subject will receive the intervention for 28 days or until achievement of full enteral feeding, whichever comes first. Primary outcome: Days to achieve full enteral feeding when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth. Secondary outcomes: 1. Duration (days) until initiation of enteral feeds. 2. Duration (days) on parenteral nutrition. 3. Weight gain, measured by grams per day per week during therapy. 4. Occurrence of adverse effects associated with the use of metoclopramide. 5. Rate of catheter-related sepsis episodes (line positive blood cultures necessitating antibiotic treatment or catheter removal). 6. Incidence of necrotizing enterocolitis (NEC) based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray. 7. Duration of hospitalization (number of days from admission until final hospital discharge).
Subjects can be withdrawn from the study if meet one of the following criteria:
- Subject develops extrapyramidal symptoms
- Subject has not established full enteral feeding by the end of day 28 of therapy
- Withdrawal of informed consent or refusal of further study participation by parent/legal guardian
- Serious adverse event which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Any clinical adverse event, laboratory abnormality or intercurrent illness which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Unpredictable discontinuation of metoclopramide drug supply
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous metoclopramide | Experimental | Drug: intravenous metoclopramidethe experimental arm will receive intravenous metoclopramide |
| control arm | Placebo comparator | Other: Placebothe control arm will receive placebo |
Who may qualify
- Ages
- 33 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure)
- Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment
Key exclusion criteria (5 listed)
- Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility)
- Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis)
- Gestational age <32 weeks
- Birth weight < 1500 gm
- Received an investigational product within the past 30 days
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 |
|---|---|---|
| intravenous metoclopramidethe experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age | Drug | intravenous metoclopramide |
| Placeboequivalent volume to intravenous metoclopramide (dosed according to the current Sick Kids guidelines based upon weight and age ) of sterile sodium chloride 0.9% injection as a placebo | Other | control arm |
Primary outcome
Days to achieve full enteral feeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Days to achieve full enteral feeding will be recorded when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth
7 secondary outcomes
Duration until initiation of enteral feeds
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Duration on parenteral nutrition
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Weight gain
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Occurrence of adverse effects
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Rate of catheter-related sepsis episodes
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Duration of hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study was stopped early (reason given: Decision to prematurely close the trial was made because of poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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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.
Jacob C Langer, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous metoclopramide in people with Gastroschisis, run by The Hospital for Sick Children at 1 site in Canada.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Dec 2019. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Decision to prematurely close the trial was made because of poor recruitment.). Results are not available in the source record.
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?
Days to achieve full enteral feeding (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2019.