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

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ClinicalTrials.gov Identifier: NCT01139853
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : September 28, 2015
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

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.

Condition or disease Intervention/treatment Phase
Pyloric Stenosis Device: Nasogastric Tube Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2010
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Feasibility [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. post-operative length of stay [ Time Frame: 1 year ]
  2. rates of post-operative emesis [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01139853     History of Changes
Other Study ID Numbers: POINTS
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
pyloric stenosis
nasogastric tube

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