Clinical trial NCT02184780: Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood
Official title: Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anaesthesia
Neurodevelopment
Keywords: Neurodevelopment
General Anaesthesia
Infants
Epidural
Spinal
Anxiety and depression
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Human Development and Potential (IHDP), Singapore
First posted: 2014-07-09
Enrollment: 468
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Neurocognitive score
timeFrame: 24 months of age
Secondary outcomes:
measure: Neurocognitive Score (Deferred Imitation)
timeFrame: 6, 18 and 24 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Choon L Bong, MBChB
role: PRINCIPAL_INVESTIGATOR
References: