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

Pyloric Stenosis Clinical Trial

— POINTS  

Official title:

Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139853
• Other study ID #: POINTS
• Status: Completed
• Phase: Phase 0
• First received: June 7, 2010
• Last updated: September 25, 2015
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Device:
• Nasogastric Tube
Insertion of a 10 French Nasogastric tube prior to surgery

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility		2 years	No
Secondary	post-operative length of stay		1 year	No
Secondary	rates of post-operative emesis		1 year	No

External Links

•   MPSRC-McMaster Pediatric Surgery Research Collaborative