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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gastric Tube in Pyloric Stenosis

NCT05068622

Hypertrophic Pyloric Stenosis Respiratory Complication

UNKNOWN

The Impact of Nasogastric Indwelling Versus Oral Intermittent Tube Feeding Methods on Premature Infants

NCT00798824

Premature Infants

COMPLETED NA

Gastric Lipase Enhanced Nasogastric Tube Study in Neonates

NCT04271995

Neonatal Disorder

COMPLETED

Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

NCT00365703

Infant, Premature

COMPLETED NA

Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study

NCT06274944

Premature Birth

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pyloric Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasogastric Tube

10 French Nasogastric Tube inserted before surgery

Group Type ACTIVE_COMPARATOR

Nasogastric Tube

Intervention Type DEVICE

Insertion of a 10 French Nasogastric tube prior to surgery

No Nasogastric Tube

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasogastric Tube

Insertion of a 10 French Nasogastric tube prior to surgery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No