Status:
COMPLETED
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Conditions:
Pyloric Stenosis
Eligibility:
All Genders
Up to 6 years
Phase:
EARLY_PHASE1
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 l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01139853
Start Date
January 1 2010
End Date
January 1 2015
Last Update
September 28 2015
Active Locations (1)
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1
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N3Z5