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

• Conditions: Neurodevelopment; Anaesthesia

• Registration Number: NCT02184780
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Status Verified: 2017-03
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 468

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neurocognitive score	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 Outcome Measures

Name	Time	Method
Neurocognitive Score (Deferred Imitation)	6, 18 and 24 months	Neurocognitive scores as measured by deferred imitation, a test of memory and attention. 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.

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore