Enterocolitis, NecrotizingToSCiNNCT04713579
Timing of Stoma Closure in Neonates
An observational study of Enterocolitis, Necrotizing and Atresia; Bowel, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Enterocolitis, Necrotizing, Atresia; Bowel, Gastroschisis
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2021to 31 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Workstream 1: clinicians involved in caring for infants with stomas in UK surgical units. Workstream 2.1: Infants who have had a stoma formed as part of emergency surgery before 44 weeks post-conceptual age. Workstream 2.2: clinicians involved in caring for infants recruited to WS 2.1. Workstream 2.3: Parents of premature and term infants who have had an stoma in the last three years; clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.
Who may be able to join
- Neonatologists in surgical NICUs, neonatal surgeons, neonatal dieticians and neonatal surgical nurses.
- Workstream 2.1
- Infants having a stoma as part of emergency surgery before 44 weeks post-conceptual age: Group A preterm infants who have stomas formed for necrotising enterocolitis, spontaneous intestinal perforation or other intestinal pathology, and Group B infants (usually born closer to term) who have congenital anomalies that lead to bowel obstruction (e.g. intestinal atresias; meconium ileus and other conditions such as complicated gastroschisis).
- Lead surgeons and neonatologists caring for infants recruited to WS 2.1.
- Workstream 2.3
- Parents of premature and term infants who have had an stoma in the last three years (including parents of infants recruited to WS 2.1).
- Clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.
Who cannot join
- Cases where a stoma is part of a planned treatment pathway e.g. for an anorectal malformation or Hirschsprung's disease.
- Infants who have a stoma formed after 44 weeks post-conceptual age.
- Workstream 2.2
- Parents who do not speak English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester
About this study
Official title: Timing of Stoma Closure in Neonates (ToSCiN)
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or "close" the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be better; however surgery is safer when babies are older and bigger so later closure may be better.
This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes).
The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies to help decide whether a clinical trial is possible.
Read the detailed description
Neonates undergoing emergency abdominal surgery frequently require stoma formation. Reversing (closing) these stomas with a second operation is an essential part of the infant's recovery. The timing of this closure is highly variable around the United Kingdom (UK) and the best time remains unclear. Current evidence is of low methodological quality and presents mixed conclusions: determining the best time has significant potential benefits for: (i) infant health outcomes (short-term e.g. avoiding complications and long-term e.g. growth and neurodevelopment); ii) families (e.g. reduced Neonatal Intensive Care Unit (NICU) stay); and iii) healthcare providers (e.g. reduced costs). Ideally, a clinical trial to compare early and late closure would be conducted but this is likely to be challenging and may not be feasible or acceptable to parents and clinicians.
Aims and objectives:
This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes).
Methods:
The study will use a mixed-methods approach comprising three parallel workstreams (WS). WS 1 will be a national survey of clinician perspectives of neonatal stoma closure. WS 2 will use an observational cohort study, interviews, questionnaires and focus groups. WS 3 will analyse three existing large databases (National Neonatal Research Database (NNRD), Health Episode Statistics (HES) and British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CASS)).
The findings of these WS will be combined and presented at a final, trial design meeting where conclusions about trial feasibility will be reached and if appropriate, an outline of a trial protocol agreed.
Anticipated impact and dissemination:
The principal impact will be determining whether or not a definitive trial can go ahead: if the study demonstrates that a trial is feasible then the investigators will use their findings to design a trial that is acceptable to parents and clinicians; that includes the most appropriate infants; that measures outcomes important to parents and clinicians and ultimately, answers the question: when is the best time to close an infant's stoma? Findings will be disseminated at national meetings of relevant professionals, through social media (including patient groups), to funding bodies and in open access publications.
- Conditions
- Enterocolitis, Necrotizing, Atresia; Bowel, Gastroschisis, Meconium Ileus, Premature Birth, Bowel Obstruction
- Being tested
- No intervention - observational study
- Keywords
- Stoma closure, Infant, Neonatal
- Medical subject headings
- Enterocolitis, Necrotizing, Intestinal Atresia, Gastroschisis, Meconium Ileus, Premature Birth, Intestinal Obstruction, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational studyOther
There is no intervention in this study as it is purely observational.
| Study group | Role | What they receive |
|---|---|---|
| Premature infants | Infants born prematurely requiring a stoma for condition such as necrotizing enterocolitis (NEC) or spontaneous intestinal perforation (SIP). Receives: Other: No intervention - observational study | |
| Term Infants | Infants born closer to term requiring a stoma e.g. for congenital causes of bowel obstruction such as intestinal atresia, gastroschisis or meconium ileus Receives: Other: No intervention - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a future trial comparing early and late stoma closure
The key research question 'Is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' will be answered by completing the series of secondary outcome measures using qualitative mixed research methods
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
To establish current UK practice for stoma closure in neonates
Find out what is currently happening in the UK for stoma closure in babies
Measured: through study completion, an average of 1 year
To determine whether there is equipoise amongst clinicians (neonatal surgeons, and neonatologists) and allied health professionals (specialist nurses and dieticians) over when it is best to close stomas in neonates
Find out whether surgeons, neonatal doctors and other professionals like dietitians are genuinely uncertain about when it is best for stomas to be closed
Measured: through study completion, an average of 1 year
To determine the willingness of parents, neonatal surgeons and neonatologists to include neonates in a trial that would randomise to 'early' or 'late' stoma closure and identify potential barriers to recruitment.
Find out if parents, surgeons and neonatal doctors would be willing to include babies in a trial that would randomly allocate them (like tossing a coin) to 'early' or 'late' stoma closure
Measured: through study completion, an average of 1 year
To define 'early' and 'late' stoma closure for a potential trial.
Decide what is meant by 'early' and 'late' stoma closure for a potential trial
Measured: through study completion, an average of 1 year
Identify a group of babies for inclusion in a trial and find out how many of these babies could be included in the UK.
To define a population of neonates for inclusion in a trial (in whom there is significant uncertainty over timing) and determine how many babies are eligible for inclusion.
Measured: through study completion, an average of 1 year
Find the most appropriate design for a potential trial
To establish the most appropriate design and outcome measures for a trial.
Measured: through study completion, an average of 1 year
To assess the suitability of using routinely collected data for gathering clinical information for a trial.
Find out if current national databases could be used for gathering the required information for a potential trial
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start17 Feb 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocolitis, NecrotizingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Oxford, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Nick Lansdale, MB FRCS PhD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713579
- Sponsor's protocol ID
- B00984
- Other IDs
- G69250
- Acronym
- ToSCiN
- Status last verified
- Jan 2023
- First submitted
- 9 Nov 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Stoma Closure in Neonates (ToSCiN)
- ClinicalTrials.gov ID
- NCT04713579
- Acronym / sponsor ID
- ToSCiN / B00984
- Conditions
- Enterocolitis, Necrotizing, Atresia; Bowel, Gastroschisis, Meconium Ileus, Premature Birth, Bowel Obstruction
- Keywords
- Stoma closure, Infant, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Oxford, University of Liverpool
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Jan 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.
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or "close" the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be better; however surgery is safer when babies are older and bigger so later closure may be better.
This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes).
The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies to help decide whether a clinical trial is possible.
Detailed description
Neonates undergoing emergency abdominal surgery frequently require stoma formation. Reversing (closing) these stomas with a second operation is an essential part of the infant's recovery. The timing of this closure is highly variable around the United Kingdom (UK) and the best time remains unclear. Current evidence is of low methodological quality and presents mixed conclusions: determining the best time has significant potential benefits for: (i) infant health outcomes (short-term e.g. avoiding complications and long-term e.g. growth and neurodevelopment); ii) families (e.g. reduced Neonatal Intensive Care Unit (NICU) stay); and iii) healthcare providers (e.g. reduced costs). Ideally, a clinical trial to compare early and late closure would be conducted but this is likely to be challenging and may not be feasible or acceptable to parents and clinicians.
Aims and objectives:
This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes).
Methods:
The study will use a mixed-methods approach comprising three parallel workstreams (WS). WS 1 will be a national survey of clinician perspectives of neonatal stoma closure. WS 2 will use an observational cohort study, interviews, questionnaires and focus groups. WS 3 will analyse three existing large databases (National Neonatal Research Database (NNRD), Health Episode Statistics (HES) and British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CASS)).
The findings of these WS will be combined and presented at a final, trial design meeting where conclusions about trial feasibility will be reached and if appropriate, an outline of a trial protocol agreed.
Anticipated impact and dissemination:
The principal impact will be determining whether or not a definitive trial can go ahead: if the study demonstrates that a trial is feasible then the investigators will use their findings to design a trial that is acceptable to parents and clinicians; that includes the most appropriate infants; that measures outcomes important to parents and clinicians and ultimately, answers the question: when is the best time to close an infant's stoma? Findings will be disseminated at national meetings of relevant professionals, through social media (including patient groups), to funding bodies and in open access publications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature infants | – | Other: No intervention - observational studyInfants born prematurely requiring a stoma for condition such as necrotizing enterocolitis (NEC) or spontaneous intestinal perforation (SIP). |
| Term Infants | – | Other: No intervention - observational studyInfants born closer to term requiring a stoma e.g. for congenital causes of bowel obstruction such as intestinal atresia, gastroschisis or meconium ileus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Workstream 1: clinicians involved in caring for infants with stomas in UK surgical units. Workstream 2.1: Infants who have had a stoma formed as part of emergency surgery before 44 weeks post-conceptual age. Workstream 2.2: clinicians involved in caring for infants recruited to WS 2.1. Workstream 2.3: Parents of premature and term infants who have had an stoma in the last three years; clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.
Key inclusion criteria (7 listed)
- Neonatologists in surgical NICUs, neonatal surgeons, neonatal dieticians and neonatal surgical nurses.
- Workstream 2.1
- Infants having a stoma as part of emergency surgery before 44 weeks post-conceptual age: Group A preterm infants who have stomas formed for necrotising enterocolitis, spontaneous intestinal perforation or other intestinal pathology, and Group B infants (usually born closer to term) who have congenital anomalies that lead to bowel obstruction (e.g. intestinal atresias; meconium ileus and other conditions such as complicated gastroschisis).
- Lead surgeons and neonatologists caring for infants recruited to WS 2.1.
- Workstream 2.3
Key exclusion criteria (4 listed)
- Cases where a stoma is part of a planned treatment pathway e.g. for an anorectal malformation or Hirschsprung's disease.
- Infants who have a stoma formed after 44 weeks post-conceptual age.
- Workstream 2.2
- Parents who do not speak English.
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 |
|---|---|---|
| No intervention - observational studyThere is no intervention in this study as it is purely observational. | Other | Premature infants, Term Infants |
Primary outcome
Feasibility of a future trial comparing early and late stoma closure
Time frame: through study completion, an average of 1 year
The key research question 'Is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' will be answered by completing the series of secondary outcome measures using qualitative mixed research methods
7 secondary outcomes
To establish current UK practice for stoma closure in neonates
Time frame: through study completion, an average of 1 year
To determine whether there is equipoise amongst clinicians (neonatal surgeons, and neonatologists) and allied health professionals (specialist nurses and dieticians) over when it is best to close stomas in neonates
Time frame: through study completion, an average of 1 year
To determine the willingness of parents, neonatal surgeons and neonatologists to include neonates in a trial that would randomise to 'early' or 'late' stoma closure and identify potential barriers to recruitment.
Time frame: through study completion, an average of 1 year
To define 'early' and 'late' stoma closure for a potential trial.
Time frame: through study completion, an average of 1 year
Identify a group of babies for inclusion in a trial and find out how many of these babies could be included in the UK.
Time frame: through study completion, an average of 1 year
Find the most appropriate design for a potential trial
Time frame: through study completion, an average of 1 year
To assess the suitability of using routinely collected data for gathering clinical information for a trial.
Time frame: through study completion, an average of 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 18 Jan 2023.
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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.
Nick Lansdale, MB FRCS PhD principal investigator
Manchester University NHS Foundation Trust
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 Enterocolitis, Necrotizing and Atresia; Bowel, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 4 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 18 Jan 2023. 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 Kingdom. 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?
Feasibility of a future trial comparing early and late stoma closure (time frame: through study completion, an average of 1 year). 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 18 Jan 2023.