Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
POINTS
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2010
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedSeptember 28, 2015
September 1, 2015
5 years
June 7, 2010
September 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility
2 years
Secondary Outcomes (2)
post-operative length of stay
1 year
rates of post-operative emesis
1 year
Study Arms (2)
Nasogastric Tube
ACTIVE COMPARATOR10 French Nasogastric Tube inserted before surgery
No Nasogastric Tube
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamilton Health Sciences Corporationlead
- McMaster Universitycollaborator
Study Sites (1)
McMaster University Medical Center
Hamilton, Ontario, L8N3Z5, Canada
Related Publications (1)
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.
PMID: 25783381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Helene Flageole, MD, FRCSC
McMaster Children's Hopsital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
September 28, 2015
Record last verified: 2015-09