Overview

This trial is active, not recruiting.

Conditions anaesthesia, neurodevelopment
Sponsor KK Women's and Children's Hospital
Collaborator Singapore Institute for Clinical Sciences
Start date September 2013
End date September 2016
Trial size 468 participants
Trial identifier NCT02184780, CIRB/2013/644/D

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.

Primary Outcomes

Measure
Neurocognitive score
time frame: 24 months of age

Secondary Outcomes

Measure
Neurocognitive Score (Deferred Imitation)
time frame: 6, 18 and 24 months

Eligibility Criteria

Male or female participants from 2 years up to 4 years old.

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.

Additional Information

Official title Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO Study)
Principal investigator Choon L Bong, MBChB
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by KK Women's and Children's Hospital.