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NCT Number: NCT01139853

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

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.

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Key information

Conditions

Pyloric Stenosis Digestive System Diseases Gastric Outlet Obstruction Gastrointestinal Diseases Stomach Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

McMaster University Medical Center

Hamilton, Ontario, L8N3Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female infant ≤ 6 months of age
  • Primary diagnosis of Pyloric Stenosis confirmed by ultrasound
  • Amendable to circumumbilical pyloromyotomy
  • Amendable to a minimum size 10 French nasogastric tube
  • Able to undergo general anesthesia
  • Parent or legal guardian able to give free and informed consent

Exclusion criteria

  • Contraindicated for circumumbilical pyloromyotomy
  • Contraindicated for a size 10 French nasogastric tube
  • Prematurity before 35 weeks' gestation
  • Bronchopulmonary dysplasia
  • Viral infection in the past 7 days
  • Cardiac malformation
  • Patent ductus arteriosis
  • Previous abdominal surgery
  • Concurrent surgical procedure scheduled
  • Parent or legal guardian unable to read, speak and understand English
  • Co-enrolled in a different interventional trial

Treatment and study plan

Nasogastric tube

Device

Insertion of a 10 French Nasogastric tube prior to surgery

Primary outcomes

  1. Feasibility

    Time frame: 2 years

Secondary outcomes

  1. post-operative length of stay

    Time frame: 1 year

  2. rates of post-operative emesis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Acronym: POINTS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2010
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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