- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02184780
Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO)
Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO Study)
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:
- Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive outcomes at 6, 18, 24 and 36 months.
- Maternal anxiety and depression during the antenatal and post-partum period is associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.
연구 개요
상세 설명
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
- The infants' perinatal exposure to anaesthesia and analgesia, as obtained from hospital records, and
- Maternal anxiety and depression, as observed from analysis of questionnaires already available from GUSTO.
We hypothesize that:
- Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive outcomes at 6, 18, 24 and 36 months.
- Maternal anxiety and depression during the antenatal and post-partum period is associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 229899
- KK Women's and Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Neurocognitive score
기간: 24 months of age
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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.
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24 months of age
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Neurocognitive Score (Deferred Imitation)
기간: 6, 18 and 24 months
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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.
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6, 18 and 24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Choon L Bong, MBChB, KK Women's and Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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