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

This study is currently recruiting participants.
Verified July 2011 by McMaster University
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT01139853
First received: June 7, 2010
Last updated: June 17, 2012
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pyloric Stenosis
 Device: Nasogastric Tube
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-operative length of stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • rates of post-operative emesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Device: Nasogastric Tube
Insertion of a 10 French Nasogastric tube prior to surgery

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139853

Contacts
Contact: Julia Pemberton, MSc 905-521-2100 ext 76692 pemberj@mcmaster.ca

Locations
Canada, Ontario
McMaster University Medical Center Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Helene Flageole, MD, FRCSC     905-521-2100 ext 75244     flageol@mcmaster.ca    
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Dr. Helene Flageole, MD, FRCSC McMaster Children's Hopsital
  More Information

Additional Information:
MPSRC-McMaster Pediatric Surgery Research Collaborative  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT01139853     History of Changes
Other Study ID Numbers: POINTS
Study First Received: June 7, 2010
Last Updated: June 17, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
pyloric stenosis
nasogastric tube
pyloromyotomy

Additional relevant MeSH terms:
Constriction, Pathologic
Pyloric Stenosis
Gastric Outlet Obstruction
Pathological Conditions, Anatomical
 Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013