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Metoclopramide Pilot Trial

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ClinicalTrials.gov Identifier: NCT02098915
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Jacob Langer, The Hospital for Sick Children

Brief 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. Investigators hypothesize that a prokinetic agent given intravenously (infused into a vein) may be effective in improving gut motility in children with gastroschisis.

Condition or disease Intervention/treatment Phase
Gastroschisis Drug: intravenous metoclopramide Other: Placebo Phase 3

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Subjects can be withdrawn from the study if meet one of the following criteria: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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
Study Start Date : March 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: intravenous metoclopramide
the experimental arm will receive intravenous metoclopramide
Drug: intravenous metoclopramide
the experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age

Placebo Comparator: control arm
the control arm will receive placebo
Other: Placebo
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration until initiation of enteral feeds [ 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. Duration (days) until initiation of enteral feeds will be recorded

  2. Duration on parenteral nutrition [ 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. Duration (days) on parenteral nutrition will be recorded

  3. Weight gain [ 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. Weight gain, measured by grams per day per week during therapy will be recorded

  4. Occurrence of adverse effects [ 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. Occurrence of adverse effects associated with the use of metoclopramide will be recorded.

  5. Rate of catheter-related sepsis episodes [ 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. Rate of catheter-related sepsis episodes during intravenous treatment (line positive blood cultures necessitating antibiotic treatment or catheter removal) will be recorded.

  6. Incidence of necrotizing enterocolitis (NEC) [ 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. 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.

  7. Duration of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Duration of hospitalization (number of days from admission until final hospital discharge) will be recorded.



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Ages Eligible for Study:   33 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure)
  2. Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment

Exclusion Criteria:

  1. Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility)
  2. Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis)
  3. Gestational age <32 weeks
  4. Birth weight < 1500 gm
  5. Received an investigational product within the past 30 days

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): NCT02098915


Contacts
Contact: Christopher Tomlinson, MD 416-813-2474 ext 302474 christopher.tomlinson@sickkids.ca
Contact: Eveline Lapidus-Krol, MSc 416-813-6542 ext 306542 eveline.lapidus-krol@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Christopher Tomlinson, MD    416-813-2474 ext 302474    christopher.tomlinson@sickkids.ca   
Contact: Eveline Lapidus-Krol, Msc    416-813-6542 ext 306542    eveline.lapidus-krol@sickkids.ca   
Principal Investigator: Jacob C Langer, MD         
Sub-Investigator: Christopher Tomlinson, MD         
Sub-Investigator: Eveline Lapidus-Krol, MSc         
Sub-Investigator: Paul Wales, MD         
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Jacob C Langer, MD University of Toronto

Responsible Party: Jacob Langer, Jacob C Langer, MD, FRCSC, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02098915     History of Changes
Other Study ID Numbers: 1000038585
169334 ( Other Identifier: Health Canada )
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Keywords provided by Jacob Langer, The Hospital for Sick Children:
gastroschisis
intestinal motility
prokinetic agents
intravenous metoclopramide
time to full enteral feeding

Additional relevant MeSH terms:
Hernia, Abdominal
Hernia
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
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