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

Early Phase 1CompletedNCT01139853

Hamilton Health Sciences Corporation50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pyloric Stenosis

Interventions

Nasogastric Tube

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility

Time frame: 2 years

Secondary Outcomes

post-operative length of stay

Time frame: 1 year

rates of post-operative emesis