Central Nervous System Complications of AnesthesiaEGAINNCT02182817
Exposure to General Anaesthesia in Infancy and Neurocognitive Development
An observational study of Central Nervous System Complications of Anesthesia and Impaired Cognition, run by KK Women's and Children's Hospital at 2 sites in Singapore.
Trial summary
This prospective cohort study aims to determine if apparently healthy children with no significant co-morbidities who undergo general anaesthesia for minor surgery before 15 months of age will develop measurable deficits in neurocognitive development compared to apparently healthy children with no significant… Read more about this study
- Who is it for?
- Ages 1 day to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Central Nervous System Complications of Anesthesia, Impaired Cognition
- How many people
- 250 participants
- Where
- 2 sitesSingapore
- Study dates
- Nov 2013to Dec 2021
- 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 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full-term infants with no significant co-morbidities presenting for minor surgery at KK Womens' and children's hospital, Singapore
Who may be able to join
- Infants born > 36 weeks gestation
- No significant co-morbidities
- Who undergo general sevoflurane anaesthesia for minor surgery lasting <150 minutes (including herniotomies, orchidopexies, circumcisions and pyloromyotomies) before 15 months of age
Who cannot join
- Prematurity <36 weeks gestation
- Birth weight less than 2400g
- Presence of a genetic or chromosomal disorder
- Disorder of the central nervous system, including any seizure disorder
- Major congenital cardiac defects
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore Institute of Clinical Sciences
Singapore, 117609
KK Women's and Children's Hospital. 100 Bukit Timah Road
Singapore, 229899
About this study
Official title: Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
This prospective cohort study aims to determine if apparently healthy children with no significant co-morbidities who undergo general anaesthesia for minor surgery before 15 months of age will develop measurable deficits in neurocognitive development compared to apparently healthy children with no significant co-morbidities who do not undergo general anaesthesia or surgery.
Read the detailed description
We hypothesize that healthy children exposed to general anaesthesia for minor surgery before 15 months of age will have significantly lower neurocognitive scores at 6,18, 24 and 36 months of age compared with age, and gender matched healthy children from the GUSTO cohort without prior exposure to general anaesthesia or surgery. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population).
- Keywords
- General Anaesthesia, Neurocognitive Development, Behaviour
- Medical subject headings
- Cognition Disorders, Behavior
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 |
|---|---|---|
| GA-Exposed Group | Exposure to general anaesthesia below 15 months of age | |
| Unexposed Group | Children not exposed to general anaesthesia or surgery from GUSTO cohort. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
Bayley's Scale of Infant Development-III
Measured: 24 months of age
Secondary outcomes (5)
Neurocognitive Assessment: Deferred Imitation
Deferred imitation is used to assess declarative memory
Measured: 6 and 18 months of age
Neurocognitive Assessment: Habituation
Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.
Measured: 6 and 18 months of age
Behavioural Assessment: Child behaviour checklist
Measured: 24 months of age
Event Related Potential
Auditory Oddball
Measured: 6 and 18 months of age
Visual Expectation
Measured: 6 and 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System Complications of AnesthesiaStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Responsible party
- Sponsor
- Investigators
- Choon L Bong, MBChB FRCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182817
- Sponsor's protocol ID
- EGAIN 2013/552/D
- Acronym
- EGAIN
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
- ClinicalTrials.gov ID
- NCT02182817
- Acronym / sponsor ID
- EGAIN / EGAIN 2013/552/D
- Keywords
- General Anaesthesia, Neurocognitive Development, Behaviour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Study start
- Nov 2013
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Jul 2014 (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.
This prospective cohort study aims to determine if apparently healthy children with no significant co-morbidities who undergo general anaesthesia for minor surgery before 15 months of age will develop measurable deficits in neurocognitive development compared to apparently healthy children with no significant co-morbidities who do not undergo general anaesthesia or surgery.
Detailed description
We hypothesize that healthy children exposed to general anaesthesia for minor surgery before 15 months of age will have significantly lower neurocognitive scores at 6,18, 24 and 36 months of age compared with age, and gender matched healthy children from the GUSTO cohort without prior exposure to general anaesthesia or surgery. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA-Exposed Group | – | –Exposure to general anaesthesia below 15 months of age |
| Unexposed Group | – | –Children not exposed to general anaesthesia or surgery from GUSTO cohort. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population) |
Who may qualify
- Ages
- 1 day to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full-term infants with no significant co-morbidities presenting for minor surgery at KK Womens' and children's hospital, Singapore
Key inclusion criteria (3 listed)
- Infants born > 36 weeks gestation
- No significant co-morbidities
- Who undergo general sevoflurane anaesthesia for minor surgery lasting <150 minutes (including herniotomies, orchidopexies, circumcisions and pyloromyotomies) before 15 months of age
Key exclusion criteria (5 listed)
- Prematurity <36 weeks gestation
- Birth weight less than 2400g
- Presence of a genetic or chromosomal disorder
- Disorder of the central nervous system, including any seizure disorder
- Major congenital cardiac defects
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
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
Time frame: 24 months of age
Bayley's Scale of Infant Development-III
5 secondary outcomes
Neurocognitive Assessment: Deferred Imitation
Time frame: 6 and 18 months of age
Neurocognitive Assessment: Habituation
Time frame: 6 and 18 months of age
Behavioural Assessment: Child behaviour checklist
Time frame: 24 months of age
Event Related Potential
Time frame: 6 and 18 months of age
Visual Expectation
Time frame: 6 and 18 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Choon L Bong, MBChB FRCA principal investigator
KK Women's and Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Complications of Anesthesia and Impaired Cognition, run by KK Women's and Children's Hospital at 2 sites in Singapore.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Results are not available in the source record.
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?
Neurocognitive Assessment: Bayley's Scale of Infant Development-III (time frame: 24 months 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 21 Feb 2021.