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

This study has been completed.
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: September 25, 2015
Last verified: September 2015

June 7, 2010
September 25, 2015
January 2010
January 2015   (final data collection date for primary outcome measure)
Feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01139853 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
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.
Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pyloric Stenosis
Device: Nasogastric Tube
Insertion of a 10 French Nasogastric tube prior to surgery
  • Active Comparator: Nasogastric Tube
    10 French Nasogastric Tube inserted before surgery
    Intervention: Device: Nasogastric Tube
  • No Intervention: No Nasogastric Tube
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01139853
POINTS
No
Not Provided
Not Provided
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: Dr. Helene Flageole, MD, FRCSC McMaster Children's Hopsital
McMaster University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP