Can 3D photography at birth help to detect prenatal alcohol exposure?
ISRCTN | ISRCTN10055429 |
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DOI | https://doi.org/10.1186/ISRCTN10055429 |
IRAS number | 241498 |
Secondary identifying numbers | IRAS 241498 |
- Submission date
- 04/01/2018
- Registration date
- 09/04/2018
- Last edited
- 07/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Prenatal alcohol exposure occurs when a woman drinks while pregnant. The aim of this study is to find out whether 3D photography and cranial (head) ultrasound imaging can detect craniofacial changes caused by prenatal alcohol exposure in newborn infants.
Who can participate?
Caucasian mothers and their babies
What does the study involve?
Mothers are asked to complete a questionnaire about their alcohol consumption before and during pregnancy. This questionnaire - which should take no longer than 5-10 minutes to complete - stays completely anonymous. The researcher then takes photographs of the baby using ordinary 2D and specialist handheld 3D cameras.
What are the possible benefits and risks of participating?
Participants contribute to medical research which may allow earlier diagnosis of babies with fetal alcohol syndrome disorders (FASD). There are no additional risks compared with normal medical care.
Where is the study run from?
1. The Royal Sussex County Hospital Maternity Wards, Brighton (UK)
2. The One Stop Clinic (a specialist clinic for pregnant mothers with substance/alcohol misuse), Brighton (UK)
This study is not open to recruitment by other centres
When is the study starting and how long is it expected to run for?
July 2017 to May 2019
Who is funding the study?
National Institute for Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (USA) through the CIFASD consortium
Who is the main contact?
Dr Neil Aiton
neil.aiton@bsuh.nhs.uk
Contact information
Scientific
Trevor Mann Baby Unit
Royal Sussex County Hospital
Brighton
BN44 3QB
United Kingdom
0000-0001-9762-1169 | |
Phone | +44 (0)1273 696955 ext 4195 |
neil.aiton@bsuh.nhs.uk |
Public
Clinical Research Facility
Royal Sussex County Hospital
1 Abbey Road
Brighton
BN2 1ES
United Kingdom
Phone | +44 (0)1273 6968955 ext: 7497 |
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scott.harfield@nhs.net |
Study information
Study design | Single-centre observational cross sectional study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Comparing 2D and 3D photography using computerised analysis for earlier detection of craniofacial changes in newborn infants with and without prenatal alcohol exposure |
Study objectives | 3D photography and cranial ultrasound imaging in the newborn infant can detect prenatal alcohol exposure. |
Ethics approval(s) | Approved 01/05/2018, South Central - Berkshire Research Ethics Committee (Bristol REC Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207104 805; berkshire.rec@hra.nhs.uk), ref: 18/SC/0211 |
Health condition(s) or problem(s) studied | Prenatal alcohol exposure |
Intervention | Babies from the One Stop Clinic who have been exposed to significant levels of alcohol during pregnancy will be recruited to the study by the Chief Investigator. Consent will be obtained directly from the mother by the Chief Investigator using a different consent form and information sheet. It is estimated that 10-20 babies will be recruited per year from the clinic. As part of the normal clinical pathway, these babies already receive a cranial ultrasound and 2D photography routinely within the first few weeks after birth. The only difference involvement in the study entails is inclusion of 3D photography in addition to the routine 2D photographs. This will be saved in a file with a unique study id number. The data concerning alcohol consumption in pregnancy will be abstracted from the clinical notes by the chief investigator. The cranial ultrasound which has been performed for clinical reasons will be anonymised using specialist software. These will be stored with same unique id number. These anonymous data images on both the alcohol and non-alcohol exposed groups will be transferred to the team at the Big Data Unit at Oxford University for further detailed 3D analysis. The images will undergo automated landmark annotation using curl, groove and twist alignment to develop automated algorithms combining surface curvature and feature detection. For initial screening this should allow a single numerical estimate of risk. Validation will come from comparison with large databases of controls and individuals diagnosed with FAS, and showing where an individual fits along the continuum between normal and full FAS features. As 3D imaging remains expensive, there will also be investigation of the comparison of 2D and 3D images to look at discriminatory performance between the two modalities. Software will be developed which may allow the use of hand-held mobile digital devices to use in screening. |
Intervention type | Other |
Primary outcome measure | 1. Facial morphology, measured by 3D photography at birth 2. Brain size, measured by cranial ultrasound at birth |
Secondary outcome measures | 1. Facial morphology, measured by 2D photography at birth 2. Prevalence of alcohol consumption in pregnancy, measured by questionnaire after birth 3. Length, birth weight and head circumference of newborn babies, measured by tape measure and scales at birth |
Overall study start date | 01/07/2017 |
Completion date | 31/05/2019 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 240 |
Total final enrolment | 761 |
Key inclusion criteria | 1. Caucasian 2. 34-42 weeks gestation 3. Born in Brighton |
Key exclusion criteria | 1. Either or both parents non-caucasian 2. Known congenital dysmorphic syndrome 3. Unresolved facial injury resulting from obstetric trauma 4. Fetal valproate exposure or fetal toluene exposure (very rare, but these have some overlapping facial characteristics) |
Date of first enrolment | 19/06/2018 |
Date of final enrolment | 18/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brighton
BN3 6BE
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Sussex County Hospital
Brighton
BN44 3QB
England
United Kingdom
Website | www.bsuh.nhs.uk |
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Funders
Funder type
Government
No information available
Results and Publications
Intention to publish date | 01/06/2022 |
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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 | Additional documents will be available from the Chief Investigator on request. Publication through presentation at conferences and scientific journals |
IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 26/07/2023 | No | No |
Editorial Notes
07/04/2022: The study contact has been updated.
28/02/2022: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/03/2018 to 19/06/2018.
3. The recruitment end date was changed from 30/03/2019 to 18/06/2019.
4. The total final enrolment was added.
5. The intention to publish date was changed from 31/05/2020 to 01/06/2022.
03/08/2018: The funder was changed from 'National Institute for Health Research' to 'National Institute for Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (USA) through the CIFASD consortium'.