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

NCT ID: NCT02184780

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

468 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-09-30

Brief Summary

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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. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive outcomes at 6, 18, 24 and 36 months.
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.

Detailed Description

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Early exposure to general anesthesia is associated long-term neurocognitive and behavioral abnormalities. However the impact of obstetric and perinatal exposure to anaesthesia and analgesia on long term neurocognitive outcomes in the absence of concurrent events (e.g. fetal hypoxia) is unknown. We aim to determine the impact of perinatal exposure to anaesthesia and analgesia on neurocognitive outcomes in early childhood by analyzing information already obtained from the local prospective observational cohort study: Growing up in Singapore Towards Healthy Outcomes (GUSTO). GUSTO is a large prospective cohort trial currently conducted in Singapore examining maternal and neonatal outcomes including metabolic, psychological and developmental outcomes.

Information on infants' neurocognitive outcomes up to 24 months old are already available and we will correlate these outcomes to

1. The infants' perinatal exposure to anaesthesia and analgesia, as obtained from hospital records, and
2. Maternal anxiety and depression, as observed from analysis of questionnaires already available from GUSTO.

We hypothesize that:

1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive outcomes at 6, 18, 24 and 36 months.
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

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Anaesthesia Neurodevelopment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Choon L Bong, MBChB

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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CIRB/2013/644/D

Identifier Type: -

Identifier Source: org_study_id

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