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

This study has been completed.
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation ) Identifier:
First received: June 7, 2010
Last updated: September 25, 2015
Last verified: September 2015

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:

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 ]

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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


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

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
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Please refer to this study by its identifier: NCT01139853

Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: Dr. Helene Flageole, MD, FRCSC McMaster Children's Hopsital
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation ) Identifier: NCT01139853     History of Changes
Other Study ID Numbers: POINTS
Study First Received: June 7, 2010
Last Updated: September 25, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
pyloric stenosis
nasogastric tube

Additional relevant MeSH terms:
Constriction, Pathologic
Gastric Outlet Obstruction
Pyloric Stenosis
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical
Stomach Diseases processed this record on October 08, 2015