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

Early Phase 1

Completed

• Conditions: Pyloric Stenosis
• Interventions: Device: Nasogastric Tube

• Registration Number: NCT01139853
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasogastric Tube	Nasogastric Tube	10 French Nasogastric Tube inserted before surgery

Primary Outcome Measures

Name	Time	Method
Feasibility	2 years

Secondary Outcome Measures

Name	Time	Method
post-operative length of stay	1 year
rates of post-operative emesis	1 year

Trial Locations

Locations (1)

McMaster University Medical Center; 🇨🇦 Hamilton, Ontario, Canada