Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis (POINTS)

September 25, 2015 updated by: Hamilton Health Sciences Corporation

Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial

The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • McMaster University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female infant ≤ 6 months of age
  2. Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
  3. Amendable to circumumbilical pyloromyotomy
  4. Amendable to a minimum size 10 French nasogastric tube
  5. Able to undergo general anesthesia
  6. Parent or legal guardian able to give free and informed consent

Exclusion Criteria:

  1. Contraindicated for circumumbilical pyloromyotomy
  2. Contraindicated for a size 10 French nasogastric tube
  3. Prematurity before 35 weeks' gestation
  4. Bronchopulmonary dysplasia
  5. Viral infection in the past 7 days
  6. Cardiac malformation
  7. Patent ductus arteriosis
  8. Previous abdominal surgery
  9. Concurrent surgical procedure scheduled
  10. Parent or legal guardian unable to read, speak and understand English
  11. Co-enrolled in a different interventional trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nasogastric Tube
10 French Nasogastric Tube inserted before surgery
Device: Nasogastric Tube
Insertion of a 10 French Nasogastric tube prior to surgery
NO_INTERVENTION: No Nasogastric Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
post-operative length of stay
Time Frame: 1 year
1 year
rates of post-operative emesis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster University

Investigators

  • Principal Investigator: Dr. Helene Flageole, MD, FRCSC, McMaster Children's Hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (ESTIMATE)

June 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POINTS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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