Neurodevelopmental DisordersNCT05196750
Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
An observational study of Neurodevelopmental Disorders and Behavior, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 10 years
- Conditions the study is for
- Neurodevelopmental Disorders, Behavior
- What is being tested?
- Behavioural questionnaires and assessments on mother and child
- How many people
- 1,176 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Aug 2021to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 years
- All sexes
- Child
Study population: All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-ups.
Who may be able to join
- All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study.
Who cannot join
- Children who dropped out of the study before 18 months of age
- Children who had subsequent exposure to general anaesthesia/surgeries/sedatives
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore, 119074
KKH Women and Children Hospital
Singapore
About this study
The study aims to determine:
- The association between Obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes.
- Mode of delivery on pediatric neurodevelopmental and behavioural outcomes.
- Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes.
- To determine if these would differ between very preterm, moderate preterm, late preterm and term infants.
Read more
The study team hypothesise that:
- Adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants.
- 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.
- The use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes.
- These differences may be more pronounced in preterm infants as compared to term infants.
Read the 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.
- Conditions
- Neurodevelopmental Disorders, Behavior
- Being tested
- Behavioural questionnaires and assessments on mother and child
- Keywords
- Obstetric Anaesthesia
- Medical subject headings
- Neurodevelopmental Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural questionnaires and assessments on mother and childOther
Questionnaires include, but not limited to, State Trait Anxiety Inventory, Beck Depression Inventory, LYNDON Maternal Health and Well Being, Facial Imitation Task, Deferred Imitation, Habituation, Relational Binding, Behavioural Observation, Mirror Self Recognition, Standardized Assessment and Experimental Task, Snack and Sticker Delay, Implicit Attitude Test
| Study group | Role | What they receive |
|---|---|---|
| Normal vaginal delivery | Maternal delivery of delivery via normal vaginal delivery Receives: Other: Behavioural questionnaires and assessments on mother and child | |
| Lower segment Caesarean section (LSCS) | Maternal delivery of delivery via lower segment Caesarean section (LSCS) Receives: Other: Behavioural questionnaires and assessments on mother and child |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
To establish an association with the prenatal, antenatal and postnatal data previously collected in the GUSTO study.
Measured: Prenatal to postnatal up to 7 years
Mode of delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Measured: Prenatal to postnatal up to 7 years
Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Measured: Prenatal to postnatal up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Aug 2021
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Choon Looi Bong, Principal investigator, KKH Women and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196750
- Sponsor's protocol ID
- CIRB 2021/2113
- Status last verified
- Jun 2023
- First submitted
- 24 Oct 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19602960Chen 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.
PubMed 28963295Curran 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.
PubMed 25348074Qiu 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.
PubMed 33044486
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obstetric Anesthesia and Delivery Mode On Neurodevelopmental And Behavioural Outcomes In A Population-Based Birth Cohort
- ClinicalTrials.gov ID
- NCT05196750
- Acronym / sponsor ID
- CIRB 2021/2113
- Conditions
- Neurodevelopmental Disorders, Behavior
- Keywords
- Obstetric Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,176 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine:
- The association between Obstetric anesthesia events at delivery (such as mode of anesthesia, drugs given, desaturation and hypotension) on pediatric neurodevelopmental and behavioural outcomes.
- Mode of delivery on pediatric neurodevelopmental and behavioural outcomes.
- Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes.
- To determine if these would differ between very preterm, moderate preterm, late preterm and term infants.
The study team hypothesise that:
- Adverse maternal events during anesthesia and labor analgesia may be associated with poorer neurodevelopmental outcomes in infants.
- 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.
- The use of labour epidural analgesia is associated with poorer neurodevelopmental and behavioural outcomes.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal vaginal delivery | – | Other: Behavioural questionnaires and assessments on mother and childMaternal delivery of delivery via normal vaginal delivery |
| Lower segment Caesarean section (LSCS) | – | Other: Behavioural questionnaires and assessments on mother and childMaternal delivery of delivery via lower segment Caesarean section (LSCS) |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-ups.
Key inclusion criteria (1 listed)
- All mothers and infants recruited into the GUSTO database from 2011 to 2016, who underwent neurodevelopmental follow-up will be included in the study.
Key exclusion criteria (2 listed)
- Children who dropped out of the study before 18 months of age
- Children who had subsequent exposure to general anaesthesia/surgeries/sedatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural questionnaires and assessments on mother and childQuestionnaires include, but not limited to, State Trait Anxiety Inventory, Beck Depression Inventory, LYNDON Maternal Health and Well Being, Facial Imitation Task, Deferred Imitation, Habituation, Relational Binding, Behavioural Observation, Mirror Self Recognition, Standardized Assessment and Experimental Task, Snack and Sticker Delay, Implicit Attitude Test | Other | Lower segment Caesarean section (LSCS), Normal vaginal delivery |
Primary outcome
Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
Time frame: Prenatal to postnatal up to 7 years
To establish an association with the prenatal, antenatal and postnatal data previously collected in the GUSTO study.
Mode of delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered
Time frame: Prenatal to postnatal up to 7 years
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Effect of labour epidural analgesia on neurodevelopmental and behavioural outcomes via questionnaires administered
Time frame: Prenatal to postnatal up to 7 years
Trend neurodevelopmental outcomes between infants born from normal vaginal delivery and LSCS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 19602960Sprung 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.
- Background: PubMed 28963295Chen 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.
- Background: PubMed 25348074Curran 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.
- Background: PubMed 33044486Qiu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon Looi Bong principal investigator
KKH Women and Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Behavior, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Obstetric anesthesia events at delivery on pediatric neurodevelopmental and behavioural outcomes via questionnaires administered (time frame: Prenatal to postnatal up to 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196750, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.