Back to resultsPost-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis (POINTS)
Primary Purpose
Pyloric Stenosis
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nasogastric Tube
Sponsored by
About this trial
This is an interventional treatment trial for Pyloric Stenosis focused on measuring pyloric stenosis, nasogastric tube, pyloromyotomy
Eligibility Criteria
Inclusion Criteria:
- Male or female infant ≤ 6 months of age
- Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
- Amendable to circumumbilical pyloromyotomy
- Amendable to a minimum size 10 French nasogastric tube
- Able to undergo general anesthesia
- Parent or legal guardian able to give free and informed consent
Exclusion Criteria:
- Contraindicated for circumumbilical pyloromyotomy
- Contraindicated for a size 10 French nasogastric tube
- Prematurity before 35 weeks' gestation
- Bronchopulmonary dysplasia
- Viral infection in the past 7 days
- Cardiac malformation
- Patent ductus arteriosis
- Previous abdominal surgery
- Concurrent surgical procedure scheduled
- Parent or legal guardian unable to read, speak and understand English
- Co-enrolled in a different interventional trial
Sites / Locations
- McMaster University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Nasogastric Tube
No Nasogastric Tube
Arm Description
10 French Nasogastric Tube inserted before surgery
Outcomes
Primary Outcome Measures
Feasibility
Secondary Outcome Measures
post-operative length of stay
rates of post-operative emesis
Full Information
NCT ID
NCT01139853
First Posted
June 7, 2010
Last Updated
September 25, 2015
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT01139853
Brief Title
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
Acronym
POINTS
Official Title
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyloric Stenosis
Keywords
pyloric stenosis, nasogastric tube, pyloromyotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasogastric Tube
Arm Type
Active Comparator
Arm Description
10 French Nasogastric Tube inserted before surgery
Arm Title
No Nasogastric Tube
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Nasogastric Tube
Intervention Description
Insertion of a 10 French Nasogastric tube prior to surgery
Primary Outcome Measure Information:
Title
Feasibility
Time Frame
2 years
Secondary Outcome Measure Information:
Title
post-operative length of stay
Time Frame
1 year
Title
rates of post-operative emesis
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female infant ≤ 6 months of age
Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
Amendable to circumumbilical pyloromyotomy
Amendable to a minimum size 10 French nasogastric tube
Able to undergo general anesthesia
Parent or legal guardian able to give free and informed consent
Exclusion Criteria:
Contraindicated for circumumbilical pyloromyotomy
Contraindicated for a size 10 French nasogastric tube
Prematurity before 35 weeks' gestation
Bronchopulmonary dysplasia
Viral infection in the past 7 days
Cardiac malformation
Patent ductus arteriosis
Previous abdominal surgery
Concurrent surgical procedure scheduled
Parent or legal guardian unable to read, speak and understand English
Co-enrolled in a different interventional trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Helene Flageole, MD, FRCSC
Organizational Affiliation
McMaster Children's Hopsital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25783381
Citation
Flageole HH, Pemberton J. Post-Operative Impact of Nasogastric Tubes on length of stay in infants with pyloric Stenosis (POINTS): A prospective randomized controlled pilot trial. J Pediatr Surg. 2015 Oct;50(10):1681-5. doi: 10.1016/j.jpedsurg.2015.02.023. Epub 2015 Feb 19.
Results Reference
derived
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Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
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