Neurodevelopment of babies born to mothers with epilepsy study
| ISRCTN | ISRCTN98260309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98260309 |
| Secondary identifying numbers | 16727 |
- Submission date
- 11/04/2016
- Registration date
- 26/04/2016
- Last edited
- 26/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims:
Exposure in the womb to certain medications is associated with an increased risk of both physical and developmental problems. Reductions in developmental functioning can have lifelong implications for the child, including poor educational achievement and lower skilled occupational prospects in adult life. Effects on development are not always apparent at birth and problems may go unnoticed for many years after a medication has received its licence. There are methods of investigating adverse effects of exposure to medications in the womb but typically they only look at the physical development of the child and they cover very large regions. Typically, when measuring development the child is assessed in person. This poses financial and time limitations for assessing large numbers of individuals from a large region or entire country. This study seeks to investigate the reliability of using questionnaires filled in by the parents of children known to have been exposed to medications in the womb. If such measures are reliable then they would offer a cost effective way to assess large numbers of children across large regions and would speed up the information which can be collected on medications which are commonly used during pregnancy.
Who can participate?
Pregnant women in their first or second trimester, diagnosed with epilepsy and are either taking antiepileptic medications or not.
What does the study involve?
The study involves interviewing each participant briefly during their pregnancy about their health and background. Once the child is born, details about the child’s physical health are taken from hospital records. Each mother is then asked to complete two questionnaires about their child’s development when they are a year old and again when they are 2 years old. When the child is 2 years old, they are visited at home by a member of the study team to complete a developmental assessment with their child.
What are the possible benefits and risks of participating?
There may be no direct benefits to participants. However, following the assessment when the child is 2 years old, each parent is provided with brief feedback regarding their child’s assessment. This letter will also be copied to their GP and kept on the child’s file. If there are any concerns about specific areas of a child’s development, these are discussed with the parent and their GP and Health Visitor.
Where is the study run from?
The study is run by the University of Manchester in collaboration with Central Manchester University Hospitals NHS Foundation Trust and other collaborating hospitals.
When is the study starting and how long is it expected to run for?
July 2014 to March 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Rebecca Bromley
name.study@cmft.nhs.uk
Contact information
Public
University of Manchester
Institute of Human Development
6th Floor, St Mary’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
 ORCID ID |
0000-0003-4008-0917 |
|---|---|
| Phone | +44 161 7019139 |
| Rebecca.bromley@cmft.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Neurodevelopment of Babies Born to Mothers with Epilepsy (NaME): a observational cohort study |
| Study acronym | NaME |
| Study objectives | 1.1. Question: Is the utilisation of parental reporting for neurodevelopmental outcome feasible in large populations of children exposed to teratogens in utero? 1.2. Hypothesis: The utilisation of parental reporting for neurodevelopmental outcome will be feasible in large populations of children exposed to teratogens in utero. 2.1. Question: Is the Ages and Stages Questionnaire (ASQ) or the Vineland Adaptive Behaviour Scales (VABS) a reliable measure of neurodevelopmental impairment in populations prenatally exposed to known and unknown teratogens? Is one method more reliable than the other when considered against the Bayley Scales of Infant and Toddler Development? 2.2. Hypothesis: Parental ratings of neurodevelopment will be reliable in their detection of infants with impaired neurodevelopment. It is anticipated that the VABS is likely to be more reliable than the ASQ. 3.1. Question: Are the ratings made by parents on either the VABS or the ASQ at 12 months predictive of ratings at 24 months of age? 3.2. Hypothesis: Parental ratings of neurodevelopment will predict outcomes at 24 months of age. 4.1. Question: What is the neurodevelopmental outcome of children prenatally exposed to newer AEDs? 4.2. Hypothesis: Prenatal exposure to newer antiepileptic drugs will demonstrate different safety and risk profiles pertaining to the neurodevelopment of the child. |
| Ethics approval(s) | North West - Greater Manchester Central Research Ethics Committee, 22/04/2014, ref: 14/NW/0193 |
| Health condition(s) or problem(s) studied | Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine; UKCRC code/ Disease: |
| Intervention | Surveillance for neurodevelopmental teratogenic effects of pharmacological treatment during pregnancy is limited, the consequence of which is that treatment is unlikely to be optimised for maternal or fetal safety. This study aims to investigate the feasibility and reliability of parental reporting methods for the screening of neurodevelopmental outcomes following prenatal exposure to medications across large populations. Antiepileptic drugs (AEDs) provide a means through which to investigate such methods due to the documented outcomes for the older AEDs. Women with epilepsy, who are in their first or second trimester, will be invited to consent into this follow up study. Demographics and health information will be collected during gestation. When the child is 12 months of age the parent will complete the Ages and Stages Questionnaire (ASQ) and the Vineland Adaptive Behavior Scale (VABS). At 24 months of age the child will be assessed using the Bayley Scales of Infant and Toddler Development (Bayley Scales) and reassessed with the ASQ and VABS. Diagnostic efficiency statistics of sensitivity (percentage of children that are impaired and are classified correctly), specificity (percentage of children who are not impaired and who are classified correctly) and false positive/negative predictive values will be calculated for the parental measures in comparison to the Bayley Scales. The kappa statistic will be calculated to determine level of agreement between measures. This investigation will also provide critical information regarding neurodevelopmental outcome following prenatal exposure to newer AEDS, for which safety remains uncertain. Bayley scores at 24 months will be analysed utilising multiple regression, adjusting for confounding variables, to address this issue. |
| Intervention type | Other |
| Primary outcome measure | 1. Sensitivity and specificity of the Ages and Stages Questionnaire for assessing child development (collected at 12 and 24 months of age) 2. Behaviour and cognitive skills, assessed using Vineland Adaptive Behaviour Scale-II (collected at 12 and 24 months of age) 3. Child development, assessed using Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age) |
| Secondary outcome measures | Child development, assessed using the Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age) across individual antiepileptic drugs treatments. |
| Overall study start date | 07/07/2014 |
| Completion date | 30/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 385; UK Sample Size: 385 |
| Key inclusion criteria | 1. A diagnosis of epilepsy and either: 1.1. On antiepileptic drug treatment (experimental group) 1.2. Not on treatment (control group) 2. Living within the North West, North East of England or Northern Ireland. 3. Able to provide informed consent 4. In their first or second trimester of pregnancy |
| Key exclusion criteria | 1. Significant learning disability (defined as not able to live independently). 2. Taking non-AED medications which are known to be teratogenic (e.g. warfarin) 3. Unable to understand written or verbal English (due to the standardised assessments in use) |
| Date of first enrolment | 07/07/2014 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
Manchester
M13 9WL
United Kingdom
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
Liverpool
L8 7SS
United Kingdom
Salford
M6 8HD
United Kingdom
Kayll Road
Sunderland
SR4 7TR
United Kingdom
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Liverpool
L9 7LJ
United Kingdom
Harton Lane
South Shields
NE34 0PL
United Kingdom
North Shields
Tyne and Wear
NE29 8NH
United Kingdom
Ashton Road
Lancaster
LA1 4RP
United Kingdom
Warrington
Cheshire
WA5 1QG
United Kingdom
Liverpool Rd
Chester
Cheshire
CH2 1UL
United Kingdom
Haslingden Rd
Blackburn
BB2 3HH
United Kingdom
Crewe
Cheshire
CW1 4QJ
United Kingdom
York
North Yorkshire
YO31 8HE
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Ormskirk
Lancashire
L39 2AZ
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Durham
DH1 5TW
United Kingdom
Sponsor information
Hospital/treatment centre
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
