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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01139853

Acronym

POINTS

Enrollment

Registered

2010-06-09

Start date

2010-01-31

Completion date

2015-01-31

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyloric Stenosis

Keywords

pyloric stenosis, nasogastric tube, pyloromyotomy

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.

Interventions

DEVICENasogastric Tube

Insertion of a 10 French Nasogastric tube prior to surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Feasibility	2 years

Secondary

Measure	Time frame
post-operative length of stay	1 year
rates of post-operative emesis	1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026