Can 3D photography at birth help to detect prenatal alcohol exposure?

ISRCTN ISRCTN10055429
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Neil Aiton
Scientific

Trevor Mann Baby Unit
Royal Sussex County Hospital
Brighton
BN44 3QB
United Kingdom

ORCiD logoORCID ID 0000-0001-9762-1169
Phone +44 (0)1273 696955 ext 4195
Email neil.aiton@bsuh.nhs.uk
Mr Scott Harfield
Public

Clinical Research Facility
Royal Sussex County Hospital
1 Abbey Road
Brighton
BN2 1ES
United Kingdom

Phone +44 (0)1273 6968955 ext: 7497
Email scott.harfield@nhs.net

Study information

Study designSingle-centre observational cross sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleComparing 2D and 3D photography using computerised analysis for earlier detection of craniofacial changes in newborn infants with and without prenatal alcohol exposure
Study objectives3D 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) studiedPrenatal alcohol exposure
InterventionBabies 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 typeOther
Primary outcome measure1. Facial morphology, measured by 3D photography at birth
2. Brain size, measured by cranial ultrasound at birth
Secondary outcome measures1. 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 date01/07/2017
Completion date31/05/2019

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants240
Total final enrolment761
Key inclusion criteria1. Caucasian
2. 34-42 weeks gestation
3. Born in Brighton
Key exclusion criteria1. 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 enrolment19/06/2018
Date of final enrolment18/06/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN3 6BE
United Kingdom

Sponsor information

Brighton & Sussex University Hospitals NHS Trust
Hospital/treatment centre

Royal Sussex County Hospital
Brighton
BN44 3QB
England
United Kingdom

Website www.bsuh.nhs.uk

Funders

Funder type

Government

National Institute for Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (USA) through the CIFASD consortium

No information available

Results and Publications

Intention to publish date01/06/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planAdditional documents will be available from the Chief Investigator on request. Publication through presentation at conferences and scientific journals
IPD sharing planThe 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'.