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Clinical Trials/NCT02184780
NCT02184780
Unknown
Not Applicable

Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO Study)

KK Women's and Children's Hospital1 site in 1 country468 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anaesthesia
Sponsor
KK Women's and Children's Hospital
Enrollment
468
Locations
1
Primary Endpoint
Neurocognitive score
Last Updated
6 years ago

Overview

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. 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

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KK Women's and Children's Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Neurocognitive score

Time Frame: 24 months of age

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.

Secondary Outcomes

  • Neurocognitive Score (Deferred Imitation)(6, 18 and 24 months)

Study Sites (1)

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