GastroschisisNCT01506531
Silo Versus Primary Closure for Gastroschisis
A study testing silo for gastroschisis and Primary closure of gastroschisis in people with Gastroschisis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches. Read more about this study
- Who is it for?
- Ages 5 minutes to 2 days
- Conditions the study is for
- Gastroschisis
- What is being tested?
- silo for gastroschisis and Primary closure of gastroschisis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2018
- Phase
- Interventional
- 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 5 minutes to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gastroschisis
Who cannot join
- Born prior to 34 weeks estimated gestational age
- Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
- Inability to get parental permission before treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Bedside Silo Versus Attempted Operative Closure for Gastroschisis
The objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.
Read the detailed description
The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.
The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.
- Conditions
- Gastroschisis
- Being tested
- silo for gastroschisis, Primary closure of gastroschisis
- Keywords
- gastroschisis, silo, primary closure
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silo for gastroschisisProcedure or surgery
silo placed around abdominal contents in gastroschisis patients
Primary closure of gastroschisisProcedure or surgery
Primary closure of gastroschisis, if possible
| Study group | Role | What they receive |
|---|---|---|
| primary closure of gastroschisis | Active comparator | Attempt primary skin closure of gastroschisis shortly after birth Receives: Procedure: Primary closure of gastroschisis |
| silo for gastroschisis | Active comparator | Surgical placement of silo over gastroschisis shortly after birth Receives: Procedure: silo for gastroschisis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
The length of time required for meeting discharge criteria
Measured: 1-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506531
- Sponsor's protocol ID
- 11 09-156
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2012
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Silo Versus Attempted Operative Closure for Gastroschisis
- ClinicalTrials.gov ID
- NCT01506531
- Acronym / sponsor ID
- 11 09-156
- Conditions
- Gastroschisis
- Keywords
- gastroschisis, silo, primary closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Jan 2012 (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 objective of this study is to scientifically evaluate two different closure strategies for gastroschisis to determine if there is a difference in the two approaches.
Detailed description
The hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay.
The primary outcome variable between the two techniques will be length of hospitalization. The likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary closure of gastroschisis | Active comparator | Procedure: Primary closure of gastroschisisAttempt primary skin closure of gastroschisis shortly after birth |
| silo for gastroschisis | Active comparator | Procedure: silo for gastroschisisSurgical placement of silo over gastroschisis shortly after birth |
Who may qualify
- Ages
- 5 minutes to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with gastroschisis
Key exclusion criteria (3 listed)
- Born prior to 34 weeks estimated gestational age
- Another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.
- Inability to get parental permission before treatment.
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 |
|---|---|---|
| silo for gastroschisissilo placed around abdominal contents in gastroschisis patients | Procedure or surgery | silo for gastroschisis |
| Primary closure of gastroschisisPrimary closure of gastroschisis, if possible | Procedure or surgery | primary closure of gastroschisis |
Primary outcome
Length of hospitalization
Time frame: 1-6 weeks
The length of time required for meeting discharge criteria
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 10 Jan 2019.
- 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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silo for gastroschisis and Primary closure of gastroschisis in people with Gastroschisis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 3 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 10 Jan 2019. 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 United States. 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?
Length of hospitalization (time frame: 1-6 weeks). 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 10 Jan 2019.