Condition category
Not Applicable
Date applied
04/01/2018
Date assigned
09/04/2018
Last edited
03/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Aiton

ORCID ID

http://orcid.org/0000-0001-9762-1169

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 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 trial start date

01/07/2017

Overall trial end date

31/05/2019

Reason abandoned (if study stopped)

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

www.bsuh.nhs.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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'.