Pyloric StenosisEarly Phase 1POINTSNCT01139853
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis
A Early Phase 1 study testing Nasogastric Tube in people with Pyloric Stenosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Pyloric Stenosis
- What is being tested?
- Nasogastric Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jan 2015
- Phase
- Early Phase 1
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
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.
- Conditions
- Pyloric Stenosis
- Being tested
- Nasogastric Tube
- Keywords
- pyloric stenosis, nasogastric tube, pyloromyotomy
- Medical subject headings
- Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric TubeDevice
Insertion of a 10 French Nasogastric tube prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric Tube | Active comparator | 10 French Nasogastric Tube inserted before surgery Receives: Device: Nasogastric Tube |
| No Nasogastric Tube | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Measured: 2 years
Secondary outcomes (2)
post-operative length of stay
Measured: 1 year
rates of post-operative emesis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pyloric StenosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Dr. Helene Flageole, MD, FRCSC, Principal investigator, McMaster Children's Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139853
- Sponsor's protocol ID
- POINTS
- Acronym
- POINTS
- Status last verified
- Sep 2015
- First submitted
- 7 Jun 2010
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Flageole HH, Pemberton J. Post-Operative Impact of Nasogastric Tubes on length of stay in infants with pyloric Stenosis (POINTS): A prospective randomized controlled pilot trial. J Pediatr Surg. 2015 Oct;50(10):1681-5. doi: 10.1016/j.jpedsurg.2015.02.023. Epub 2015 Feb 19.
PubMed 25783381
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT01139853
- Acronym / sponsor ID
- POINTS / POINTS
- Conditions
- Pyloric Stenosis
- Keywords
- pyloric stenosis, nasogastric tube, pyloromyotomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jun 2010 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasogastric Tube | Active comparator | Device: Nasogastric Tube10 French Nasogastric Tube inserted before surgery |
| No Nasogastric Tube | No intervention | – |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric TubeInsertion of a 10 French Nasogastric tube prior to surgery | Device | Nasogastric Tube |
Primary outcome
Feasibility
Time frame: 2 years
2 secondary outcomes
post-operative length of stay
Time frame: 1 year
rates of post-operative emesis
Time frame: 1 year
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 28 Sep 2015.
- Derived from this study: PubMed 25783381Flageole HH, Pemberton J. Post-Operative Impact of Nasogastric Tubes on length of stay in infants with pyloric Stenosis (POINTS): A prospective randomized controlled pilot trial. J Pediatr Surg. 2015 Oct;50(10):1681-5. doi: 10.1016/j.jpedsurg.2015.02.023. Epub 2015 Feb 19.
Related trials for Pyloric Stenosis
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
Recruiting
Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer
Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
Not yet recruiting
Prophylactic PPI Use After EUS-GE Procedure
Malignant Gastric Outlet Obstruction
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.
Dr. Helene Flageole, MD, FRCSC principal investigator
McMaster Children's Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nasogastric Tube in people with Pyloric Stenosis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 6 inclusion and 11 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 28 Sep 2015. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01139853, which also lists 1 linked publication.
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 28 Sep 2015.