Surgery in Early ChildhoodNCT02595801
Surgery in Early Life and Child Development at School-entry: A Population-based Study
An observational study of Surgery in Early Childhood, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Surgery in Early Childhood
- What is being tested?
- Surgery in early childhood
- How many people
- 188,628 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Nov 2015
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children attending public or Catholic school in Ontario who have completed the Early Development Instrument
Who may be able to join
- Completion of the Early Development Instrument in Ontario
Who cannot join
- Children with physical or developmental disabilities identified in the Early Development Instrument
- Not born in Canada
- Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
- Patients of a cardiology or cardiovascular service
Trial locations and contacts
1 site in 1 country.
About this study
The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.
The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.
The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.
- Conditions
- Surgery in Early Childhood
- Being tested
- Surgery in early childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery in early childhoodOther
Also called Surgery/Anesthesia in early childhood
Surgical interventions in early childhood (prior to completion of Early Development Instrument)
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Exposure to surgery prior to completion of Early Development Instrument Receives: Other: Surgery in early childhood | |
| Reference | No exposure to surgery prior to completion of Early Development Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early developmental vulnerability
Any major domain of the Early Development Instrument in the lowest 10th percentile
Measured: Assessed between five and six years of age
Secondary outcomes (2)
Performance in specific Early Development Instrument domains
Vulnerability (percentage in lowest 10th centile); mean score
Measured: Assessed between five and six years of age
Multiple challenge index
Vulnerability (percentage in lowest 10th centile) in ≥9 sub-domains of the Early Development Instrument
Measured: Assessed between five and six years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery in Early ChildhoodStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 188,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Institute for Clinical Evaluative Sciences
- Responsible party
- Principal investigator, James O'Leary, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595801
- Sponsor's protocol ID
- 1000046454
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery in Early Life and Child Development at School-entry: A Population-based Study
- ClinicalTrials.gov ID
- NCT02595801
- Acronym / sponsor ID
- 1000046454
- Conditions
- Surgery in Early Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188,628 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- McMaster University, Institute for Clinical Evaluative Sciences
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Nov 2015 (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 central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.
The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.
The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: Surgery in early childhoodExposure to surgery prior to completion of Early Development Instrument |
| Reference | – | –No exposure to surgery prior to completion of Early Development Instrument |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children attending public or Catholic school in Ontario who have completed the Early Development Instrument
Key inclusion criteria (1 listed)
- Completion of the Early Development Instrument in Ontario
Key exclusion criteria (4 listed)
- Children with physical or developmental disabilities identified in the Early Development Instrument
- Not born in Canada
- Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
- Patients of a cardiology or cardiovascular service
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 |
|---|---|---|
| Surgery in early childhoodAlso: Surgery/Anesthesia in early childhoodSurgical interventions in early childhood (prior to completion of Early Development Instrument) | Other | Exposed |
Primary outcome
Early developmental vulnerability
Time frame: Assessed between five and six years of age
Any major domain of the Early Development Instrument in the lowest 10th percentile
2 secondary outcomes
Performance in specific Early Development Instrument domains
Time frame: Assessed between five and six years of age
Multiple challenge index
Time frame: Assessed between five and six years of age
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 17 Nov 2015.
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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 Surgery in Early Childhood, run by The Hospital for Sick Children 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 1 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 17 Nov 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.
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?
Early developmental vulnerability (time frame: Assessed between five and six years of age). 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 17 Nov 2015.