Exposure to General Anaesthesia in Infancy and Neurocogni... | NCT02182817

Studies
Exposure to General Anaesthesia in Infancy and Neurocognitive Development

NCT02182817

Sponsor

KK Women's and Children's Hospital

Status

Unknown status

Last Update Posted

Feb 21, 2021Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Central Nervous System Complications of Anesthesia
Impaired Cognition

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jul 2019Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 10, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Name	Class
Institute for Human Development and Potential (IHDP), Singapore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurocognitive Assessment: Bayley's Scale of Infant Development-III	Bayley's Scale of Infant Development-III	24 months of age

Secondary Outcomes

Measure	Description	Time Frame
Neurocognitive Assessment: Deferred Imitation	Deferred imitation is used to assess declarative memory	6 and 18 months of age
Neurocognitive Assessment: Habituation	Determines if an infant shows 'novelty preference' when stimuli are shown repeatedly.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

15 Months

Standard Ages

Child

Study Population

Full-term infants with no significant co-morbidities presenting for minor surgery at KK Womens' and children's hospital, Singapore

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Choon L Bong, MBChB FRCA	KK Women's and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore Institute of Clinical Sciences		Singapore		117609	Singapore
KK Women's and Children's Hospital. 100 Bukit Timah Road

Condition Browse Module

MeSH Terms

ID	Term
D003072	Cognition Disorders
D001519	Behavior

Ancestor Terms

ID	Term
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

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Browse Branches

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