Metoclopramide Use in Very Low Birth Weight Newborns | NCT00242450

Studies
Metoclopramide Use in Very Low Birth Weight Newborns

NCT00242450

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Aug 25, 2017Actual

Enrollment

Phase

Phase 4

Conditions

Infant, Premature

Interventions

Metoclopramide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002Actual

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Oct 19, 2005

First Submission Date that Met QC Criteria

Oct 19, 2005

First Posted Date

Oct 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2017

Last Update Posted Date

Aug 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

During the first 7 days of life very small babies will receive the drug metoclopramide or a salt solution through an intravenous line. They will also begin to receive a very small amount of breast milk or formula within the first 72 hours of life, in addition toother nourishment that is provided by an intravenous line, according to standard hospital procedure. We think that the babies who receive the medication may reach full oral feeds than babies who receive the salt solution.

Detailed Description

Clinically stable, premature babies (birth weight between 500 and 1,250g) will be randomized to receive metoclopramide (0.1 mg/kg IV q8h)or an equal volume of placebo for 7 days.A transition feeding schedule will begin within the first 72 hours of life. The time to full feeds for the 2 groups will be analyzed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Metoclopramide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Days required to attainment of full feeds.

Secondary Outcomes

Measure	Description	Time Frame
Weight at full enteral feeds (g).
Weight at discharge (g).
Duration of TPN (days).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

birth weight 500 to 1,250g
clinically stable
no contraindications to initiating minimal enteral feeding

Exclusion Criteria:

birth weight > 1,250g
clinically unstable
any major congenital anomaly
significant GI pathology
severe IUGR
cholestasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

72 Hours

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orlando daSilva, MD	University of Westen Ontario	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Joseph's Hospital		London	Ontario	N6A 4V2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9549642	Background	Kearns GL, van den Anker JN, Reed MD, Blumer JL. Pharmacokinetics of metoclopramide in neonates. J Clin Pharmacol. 1998 Feb;38(2):122-8. doi: 10.1002/j.1552-4604.1998.tb04400.x.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D062366	para-Aminobenzoates