Clinical trial NCT05196750: Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
Official title: Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Behavior
Keywords: Obstetric Anaesthesia
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 1176
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-ups.

Brief summary: The study aims to determine:

1. The association between Obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes.
2. Mode of delivery on pediatric neurodevelopmental and behavioural outcomes.
3. Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes.
4. To determine if these would differ between very preterm, moderate preterm, late preterm and term infants.

The study team hypothesise that:

1. Adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants.
2. Delivery via a lower segment caesarean section (LSCS) combined with a general anesthetic during delivery may be associated with adverse pediatric neurodevelopmental and behavioural outcomes.
3. The use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes.
4. These differences may be more pronounced in preterm infants as compared to term infants.

Detailed description: The relationship between the mode of delivery, type of anesthesia received, maternal anesthetic events at delivery and its effects on pediatric neurodevelopment and behavioral outcomes remains poorly defined with previous work showing conflicting results. Furthermore, previous studies have failed to take into account the potential effect of other antepartum anesthetic events such as the type of anesthesia, hypotension or desaturation. Furthermore, majority have failed to stratify between the subsets of premature infants, who may inherently be more susceptible to neurodevelopmental insult.

The GUSTO study is well-placed to provide unique insight with regards to these domains, due to its comprehensive, sensitive and specific follow-up of pediatric neurocognitive development and in-depth maternal anesthetic delivery data. Hence, previously collected, existing data from the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study will be utilized for this study.

This will be supplemented by additional maternal anesthetic and delivery data which the investigators aim to collect via a retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study.

Exclusion Criteria:

* Children who dropped out of the study before 18 months of age
* Children who had subsequent exposure to general anaesthesia/surgeries/sedatives

Primary outcomes:
measure: Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
timeFrame: Prenatal to postnatal up to 7 years
measure: Mode of delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
timeFrame: Prenatal to postnatal up to 7 years
measure: Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered
timeFrame: Prenatal to postnatal up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KKH Women and Children Hospital
Study officials:
affiliation: KKH Women and Children's Hospital
name: Choon Looi Bong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sprung J, Flick RP, Wilder RT, Katusic SK, Pike TL, Dingli M, Gleich SJ, Schroeder DR, Barbaresi WJ, Hanson AC, Warner DO. Anesthesia for cesarean delivery and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Aug;111(2):302-10. doi: 10.1097/ALN.0b013e3181adf481.
citation: Chen G, Chiang WL, Shu BC, Guo YL, Chiou ST, Chiang TL. Associations of caesarean delivery and the occurrence of neurodevelopmental disorders, asthma or obesity in childhood based on Taiwan birth cohort study. BMJ Open. 2017 Sep 27;7(9):e017086. doi: 10.1136/bmjopen-2017-017086.
citation: Curran EA, O'Neill SM, Cryan JF, Kenny LC, Dinan TG, Khashan AS, Kearney PM. Research review: Birth by caesarean section and development of autism spectrum disorder and attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. J Child Psychol Psychiatry. 2015 May;56(5):500-8. doi: 10.1111/jcpp.12351. Epub 2014 Oct 27.
citation: Qiu C, Lin JC, Shi JM, Chow T, Desai VN, Nguyen VT, Riewerts RJ, Feldman RK, Segal S, Xiang AH. Association Between Epidural Analgesia During Labor and Risk of Autism Spectrum Disorders in Offspring. JAMA Pediatr. 2020 Dec 1;174(12):1168-1175. doi: 10.1001/jamapediatrics.2020.3231.