---
title: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
nct_id: NCT01139853
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: Hamilton Health Sciences Corporation
study_type: INTERVENTIONAL
primary_condition: Pyloric Stenosis
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01139853.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01139853"
ct_last_update_post_date: 2015-09-28
last_seen_at: "2026-05-12T06:25:30.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis

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

**NCT ID:** [NCT01139853](https://clinicaltrials.gov/study/NCT01139853)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Hamilton Health Sciences Corporation
- **Collaborators:** McMaster University
- **Conditions:** Pyloric Stenosis
- **Start Date:** 2010-01
- **Completion Date:** 2015-01
- **CT.gov Last Update:** 2015-09-28

## 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.

## Eligibility

- **Maximum age:** 6 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Nasogastric Tube** (ACTIVE_COMPARATOR) — 10 French Nasogastric Tube inserted before surgery
- **No Nasogastric Tube** (NO_INTERVENTION)

## Interventions

- **Nasogastric Tube** (DEVICE) — Insertion of a 10 French Nasogastric tube prior to surgery

## Primary Outcomes

- **Feasibility** _(time frame: 2 years)_

## Secondary Outcomes

- **post-operative length of stay** _(time frame: 1 year)_
- **rates of post-operative emesis** _(time frame: 1 year)_

## Locations (1)

- McMaster University Medical Center, Hamilton, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mcmaster university medical center|hamilton|ontario|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01139853.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01139853*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*