Hypertrophic Pyloric StenosisSONPYLNCT05068622
Gastric Tube in Pyloric Stenosis
An observational study of Hypertrophic Pyloric Stenosis and Respiratory Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Hypertrophic Pyloric Stenosis, Respiratory Complication
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 13 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021
Who may be able to join
- all patients with hypertrophic pyloric stenosis
Who cannot join
- refusal of data collection and use from patient's parent or family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis
Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.
- Keywords
- Hypertrophic Pyloric Stenosis, gastric tube, Respiratory Complication
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with nasogastric tube before surgery | Not described | |
| patients without nasogastric tube before surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of respiratory complications before surgery
respiratory complications are defined by antibiotic use and/or oxygenotherapy and/or infection in the lungs X-ray before surgery
Measured: baseline, pre-surgery
Secondary outcomes (3)
number of : pre-operative vomiting
Measured: baseline, pre-surgery
pre-operative comfort
pre-operative comfort is evaluated by the EDIN scale
Measured: baseline, pre-surgery
pre-operative dehydration
Measured: baseline, pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start20 Sep 2021
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Pyloric StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068622
- Sponsor's protocol ID
- PI2021_843_0188
- Acronym
- SONPYL
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis
- ClinicalTrials.gov ID
- NCT05068622
- Acronym / sponsor ID
- SONPYL / PI2021_843_0188
- Keywords
- Hypertrophic Pyloric Stenosis, gastric tube, Respiratory Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with nasogastric tube before surgery | – | – |
| patients without nasogastric tube before surgery | – | – |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021
Key inclusion criteria (1 listed)
- all patients with hypertrophic pyloric stenosis
Key exclusion criteria (1 listed)
- refusal of data collection and use from patient's parent or family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of respiratory complications before surgery
Time frame: baseline, pre-surgery
respiratory complications are defined by antibiotic use and/or oxygenotherapy and/or infection in the lungs X-ray before surgery
3 secondary outcomes
number of : pre-operative vomiting
Time frame: baseline, pre-surgery
pre-operative comfort
Time frame: baseline, pre-surgery
pre-operative dehydration
Time frame: baseline, pre-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Pyloric Stenosis and Respiratory Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of respiratory complications before surgery (time frame: baseline, pre-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.