Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood

NCT02184780 | Unknown

• 1 other identifier: CIRB/2013/644/D
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained from the local prospective observational cohort study: Growing up in Singapore Towards Healthy Outcomes (GUSTO). We hypothesize that:

1. 1.Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive outcomes at 6, 18, 24 and 36 months.
2. 2.Maternal anxiety and depression during the antenatal and post-partum period is associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.

Conditions

Anaesthesia; Neurodevelopment

Keywords

Neurodevelopment; General Anaesthesia; Infants; Epidural; Spinal; Anxiety and depression

Outcome Measures

Primary Outcomes (1)

• Neurocognitive score

  Composite Bayley-III Scores in the following domains tested at 24 months of age (cognitive, language, motor, socio-emotional, general adaptability) These scores are already available from the existing cohort and will be correlated with perinatal exposure to anaesthesia and analgesia and maternal anxiety and depression.

  24 months of age

Secondary Outcomes (1)

• Neurocognitive Score (Deferred Imitation)

  6, 18 and 24 months

Study Arms (1)

GUSTO Neurocognitive Cohort

This study involves retrospective analysis of data from an existing cohort of 600 infants who were enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore Towards Healthy Outcomes). GUSTO is a prospective observational cohort study done in Singapore, where subjects were followed up from in-utero up to 36 months of age and beyond. The infants have already undergone a rigorous battery of neurocognitive tests at 6, 18, 24 and 36 months of age and their detailed demographic and medical information are available.

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study involves retrospective analysis of data from an existing cohort of 600 infants who were enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore Towards Healthy Outcomes). GUSTO is a prospective observational cohort study done in Singapore, where subjects were followed up from in-utero up to 36 months of age and beyond. The infants have already undergone a rigorous battery of neurocognitive tests at 6, 18, 24 and 36 months of age and their detailed demographic and medical information are available.

You may qualify if:

• Infants who are enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore Towards Healthy Outcomes).

You may not qualify if:

• No information available on previous exposure (maternal exposure in utero, perinatal and postnatal exposure) to general anaesthesia, spinal or epidural anaesthesia.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Institute for Human Development and Potential (IHDP), Singapore: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Choon L Bong, MBChB

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 26, 2020

Record last verified: 2017-03

Locations

SG (1)