Plain English Summary
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. Next, the researcher undertakes a cranial ultrasound of the baby. This can be done either in the cot or with a parent holding the baby. Some warmed gel (from a sterile single-use sachet) is placed on the top of the baby's head, and the ultrasound probe is then placed on the head, and the scan is performed through the 'soft spot' (the fontanelle). This takes about 5-10 minutes (no measurements are made during the scanning). When the scan is completed, the baby's head can be wiped with a tissue, and everything is completed.
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 (UK)
2. The One Stop Clinic (a specialist clinic for pregnant mothers with substance/alcohol misuse) (UK)
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 Health Research (UK)
Who is the main contact?
Dr Neil Aiton
neil.aiton@bsuh.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Neil Aiton
ORCID ID
Contact details
Trevor Mann Baby Unit
Royal Sussex County Hospital
Brighton
BN44 3QB
United Kingdom
+44 (0)1273 696955 ext 4195
neil.aiton@bsuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRAS 241498
Study information
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
Acronym
Study hypothesis
3D photography and cranial ultrasound imaging in the newborn infant can detect prenatal alcohol exposure.
Ethics approval
London - Brighton and Sussex - approval pending
Study design
Single-centre observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/07/2017
Overall trial end date
31/05/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Caucasian
2. 34-42 weeks gestation
3. Born in Brighton
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
240
Participant 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)
Recruitment start date
01/03/2018
Recruitment end date
30/03/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN3 6BE
United Kingdom
Sponsor information
Organisation
Brighton & Sussex University Hospitals NHS Trust
Sponsor details
Royal Sussex County Hospital
Brighton
BN44 3QB
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Additional documents will be available from the Chief Investigator on request. Publication through presentation at conferences and scientific journals in early 2020.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/05/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary