Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02184780
Other study ID # CIRB/2013/644/D
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2013
Est. completion date September 2020

Study information

Verified date March 2017
Source KK Women's and Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 468
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 4 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
KK Women's and Children's Hospital Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurocognitive score 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. 24 months of age
Secondary Neurocognitive Score (Deferred Imitation) 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. 6, 18 and 24 months
See also
  Status Clinical Trial Phase
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT02920749 - Study of Anaesthesia Costs and Recovery Profiles N/A
Completed NCT02025153 - Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain N/A
Completed NCT02265822 - Melatonin Premedication in Children Undergoing Surgery Phase 4
Completed NCT01457274 - "Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy N/A
Completed NCT00521612 - Sevoflurane vs. Isoflurane for Low-Flow General Anaesthesia for Abdominal Surgery N/A
Completed NCT00455117 - Effect of Parecoxib on Post-craniotomy Pain Phase 4
Completed NCT02150460 - A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria Phase 4
Completed NCT01041352 - Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position N/A
Terminated NCT02801799 - Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration Phase 1
Completed NCT02923427 - I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery N/A
Completed NCT01971996 - Measuring the Effect of External Pressure on the Regional Cerebral Oxygen Saturation Monitored by Near-infrared Spectroscopy(NIRS) Technology N/A
Completed NCT01076790 - Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli Phase 4
Completed NCT01022151 - Aminophylline and Cognitive Function After Sevoflurane Anaesthesia Phase 2
Completed NCT02442609 - Internet for Anesthesia Information : a Patient Questionaire N/A
Recruiting NCT02125838 - Laryngeal Mask Supreme During Laparoscopic Gynecologic Surgery Phase 4
Completed NCT01780571 - CPAP/PSV Preoxygenation in Obese Patients N/A
Completed NCT03380715 - A Comparison Between Co-phenylcaine Nasal Spray and Nasal Nebulization Prior to Rigid Nasoendoscopic Examination N/A
Recruiting NCT04070404 - Quality of Preoxygenation in Emergency Surgery
Completed NCT02350348 - NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia