The impact of COVID-19 infection in newborns or in pregnancy on children’s development at 18-24 months

ISRCTN	ISRCTN99910769
DOI	https://doi.org/10.1186/ISRCTN99910769
IRAS number	294183
Secondary identifying numbers	CPMS 48937, IRAS 294183

Submission date: 28/04/2022
Registration date: 06/06/2022
Last edited: 17/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims:
Two large ongoing studies, the UK Obstetric Surveillance System (UKOSS) and the British Paediatric Surveillance Unit (BPSU), identified 3000 pregnant women and 100 newborn babies who were hospitalized with the Coronavirus (SARS-CoV-2 or COVID-19) infection so far. Most of these pregnant women gave birth at term (at 37 weeks of gestation or more) and most of the newborn babies who had Coronavirus infection were also born at term. Almost all of these babies were well or were only mildly affected by the virus shortly after birth. Recent research shows that Coronavirus infection in children and adults may affect the brain. Since the development of term-born babies is not routinely checked by health professionals, we will not know whether Coronavirus infection during pregnancy or shortly after birth will affect their development as they grow. This study therefore aims to check the development of babies exposed to Coronavirus infection and compare it with the development of babies who did not have Coronavirus infection to find out if there are any lasting effects.

Who can participate?
Three groups of potential participants will be invited to take part:
1. Infants who had COVID-19 within 28 days after birth (neonatal exposure group)
2. Infants born to mothers who had COVID-19 during pregnancy (antenatal exposure group)
3. Infants who did not have COVID-19 in the first 28 days after birth, and whose mothers who did not have COVID-19 during pregnancy (comparison group)

What does the study involve?
Hospitals across the UK will send study invitation letters and information packs to mothers of infants who are eligible to take part in this study. These study information packs will include paper copies of the consent form and study entry questionnaire. Links to online versions of these forms will also be provided in the information pack. Mothers of eligible infants who would like to take part in the study will be asked to return the completed forms to the University of Bristol using the prepaid addressed return envelope provided in the information pack, or to complete the online versions of these forms if preferred. The study entry questionnaire will ask mothers to provide a contact address (email or postal) or phone number. These details will be used to contact mothers when their child is 18-24 months of age to invite them to complete questionnaires about how their child is developing. These development questionnaires can be filled in online, or if preferred, paper versions of the questionnaire will be posted along with a prepaid addressed return envelope. If translation to a different language is needed, questionnaires can be completed over the phone using translation services. These questionnaires will include the Ages and Stages Questionnaire (ASQ) which is a validated questionnaire used by professionals to monitor a child’s developmental progress. The researchers will also ask some information about the child’s medical history and health care usage.

What are the possible benefits and risks of participating?
This study will help the researchers to understand whether contracting Coronavirus during pregnancy may affect how a baby develops later in life. Although there is no direct benefit to participating, this information will help to organise support for families and children if a woman contracts Coronavirus during pregnancy and will help the NHS develop guidance and support for pregnant women. The researchers will also inform the parents of the children taking part in the study on the results of their child’s development, as assessed from the questionnaire they complete. They also plan to follow the development of children recruited into the study as they grow up. There are no disadvantages in taking part in the study. Completing the questionnaires will require up to 30 minutes.

Where is the study run from?
The study is run by the research team who are based at the University of Bristol, the National Perinatal Epidemiology Unit at the University of Oxford, the Department of Health Sciences at the University of Leicester, and Imperial College, London (UK)

When is the study starting and how long is it expected to run for?
December 2020 to December 2023

Who is funding the study?
Action Medical Research (UK)

Who is the main contact?
sinepost-study@bristol.ac.uk

Study website

Contact information

Dr Ela Chakkarapani
Scientific

D179. Level D
St Michael's Hospital
Southwell Street
Bristol
BS8 2EG
United Kingdom

ORCID ID	0000-0003-3380-047X
Phone	+44 (0) 117 342 5711
Email	ela.chakkarapani@bristol.ac.uk

Dr SINEPOST Study
Public

Level D
St Michael’s Hospital
Southwell Street
Bristol
BS2 8EG
United Kingdom

Phone	+44 (0)7862 320528
Email	sinepost-study@bristol.ac.uk

Study information

Study design	Observational; Design type: Cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	SARS-CoV-2 Infection in NEonates or in Pregnancy: Outcomes at EighTeen months (SINEPOST)
Study acronym	SINEPOST
Study objectives	Antenatal and/or neonatal exposure to SARS-CoV-2 impacts infants’ development at 18-24 months of age.
Ethics approval(s)	Approved 04/05/2021, London - Westminster Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048310; westminster.rec@hra.nhs.uk), ref: 21/PR/0431
Health condition(s) or problem(s) studied	COVID-19 (SARS-CoV-2 infection)
Intervention	SINEPOST is a population-based cohort study that is linked to the national surveillance studies of pregnant women (UK Obstetric Surveillance System) and newborn babies (British Paediatric Surveillance Unit, BPSU) hospitalized with confirmed Coronavirus infection. The SINEPOST study will determine the impact of antenatal or neonatal exposure to the Coronavirus infection on the developmental outcomes at 18 months of age. The study will apply for the Urgent Public Health Research Status and will operate through the Reproductive Health and Childbirth and Children’s Clinical Research Network (CRN). The study will begin at the Bristol hospitals, Imperial College and Nottingham. Each site will have a local principal investigator who will provide the clinical leadership. Once the study commences, the study coordinator based at the National Perinatal Epidemiology Unit in the University of Oxford will actively approach the Clinical Research Networks around the UK for inclusion in the SINEPOST study. The Study Coordinator will send the study packs to the site PIs/CRN research nurses either through email or post. The study packs will contain a letter inviting the women or parent to participate in the study from respective hospital trusts, parent information sheet, consent form and a study entry questionnaire with a unique SINEPOST ID. The participant information sheet, consent form and the study entry questionnaire for the antenatal exposure and the neonatal exposure cohort will contain the UKOSS and the BPSU study ID in addition to the SINEPOST ID. Antenatal exposure and comparator cohort recruitment The CRN research nurses will find the personal information of women who had the Coronavirus infection during pregnancy from locally held information using the UKOSS ID. They will add the personal information and address to the study pack and send the study pack to women eligible for the antenatal exposure cohort. The CRN research nurses will choose one woman who had term singleton babies but did not have Coronavirus infection during pregnancy on either side of the woman who had the Coronavirus infection during pregnancy. The CRN research nurses will add the personal information and address to the study pack. The study pack will be sent to the potential participants. Neonatal exposure cohort recruitment The CRN research nurses will identify the personal information of children who had SRAS-CoV-2 infection shortly after birth using the BPSU study ID, NHS number or date of birth sent by the study coordinator. The CRN research nurses will add the personal information and address to the study pack and send the study pack to the parents of all the eligible infants. The parent information sheet will explain the study to the parents. Parents will be able to obtain additional information about the study before consenting by contacting the study team through email or dedicated mobile number via text or call to directly communicate with the study team or leave a voice mail for the study team to return the call or will be able to write to the study team. Parents will be able to complete the consent form and the study entry questionnaire online using a computer or phone or return a completed paper form using the stamped addressed envelope. The consent form will ask for the email address, mobile number and home address in order to send the development questionnaire to the participants. The consent form will ask parents to consent to this study, and will also ask parents’ permission to store their contact details to enable us to contact them in the future for later follow-up studies and for obtaining information on their child’s educational attainment and health care usage information through linking of their child’s personal information with the Department of Education and NHS Digital. Parents will be free to choose which of these activities (none, one or more, all) to consent as appropriate. The study entry questionnaire will ask for demographic characteristics, need for translation services, their preferred mode for completing the developmental screening questionnaires at 18 months (online or over phone or paper version), any medical problems that might impact their child’s development and details of the Coronavirus infection. Key study research team will comprise of a study researcher at Bristol and a study coordinator at NPEU, Oxford. Every week, the study researcher at Bristol will inform the study coordinator based at NPEU, Oxford, the SINEPSOT IDs of the participants who have consented to participate in the study. For the participants who have not returned the consent forms within three weeks, the study coordinator will liaise with the local PI /CRN research nurses. The study coordinator will send another study pack and a reminder letter to resend to the potential participants of the antenatal and neonatal exposure cohort. Once parents consent for their child to participate in the study, the study researcher at Bristol will enroll the parents’ email address and mobile number onto the REDCap, which is a secure web-based application. The developmental screening questionnaires can be completed online or over phone or on a paper version that can be returned using the stamped addressed envelope. When the children are 17 months of age, REDCap will send the weblink for the developmental screening questionnaires through email or as a text message. If the parents do not complete the questionnaires in 2 weeks, REDCap will send an automatic reminder to the parents. The study researcher will complete the questionnaires over phone for those parents who had chosen this option. For the parents who need translation, the study researcher will use the Language Line service when the parents are called over phone to complete the questionnaire. If the questionnaires are not completed after 2 weeks following the reminder, the study researcher will contact the parents via telephone. Depending on parents’ preference, the questionnaire could either be completed over phone or online at this juncture. The researchers will use the Ages and Stages Questionnaire-version 3 (ASQ-3) and Ages and Stages Questionnaire Social-Emotional-version 2 (ASQ-SE-2) to capture the development of children in communication, gross motor, fine motor, problem solving, personal social and social-emotional skills. These questionnaires are widely used in clinical settings and research to check the development of children of this age. These questionnaires can be completed by parents. The researchers will score the questionnaires. The scores will identify whether the child’s development is within the average range for his/her age or whether they are at-risk for developmental delay. The researchers will send the results of the questionnaire to the parents. For those children whose score indicates that they may be at-risk of developmental delay, the researchers will suggest parents contact their child’s health visitor or their general practitioner for further support and assessment. Sample size The researchers estimated the sample size based on the following factors: 1. The anticipated deficit in developmental test score associated with exposure to the Coronavirus or Coronavirus associated inflammation is likely to be similar to that seen in infants who were exposed to mild birth asphyxia. 2. Based on previous studies, the anticipated response rate for the invitation to participate in the SINEPOST study using the UKOSS platform is likely to be 20%. However, given the high profile of this research topic and the willingness of the healthcare providers and the public to contribute to research about the Coronavirus, the response rates may be higher. 3. The researchers will need to increase our target sample size to robustly determine the longer-term impact of exposure to the Coronavirus on development at school-age to account for attrition to follow up after 18 months of age. Considering all these factors, the researchers have estimated that they will need 200 children in the antenatal exposure and the comparator cohort. Given the neonatal exposure cohort currently has 100 eligible children, which is likely to increase with the second wave, the researchers will invite all the eligible children to participate in the SINEPOST study aiming to recruit up to 120 children. To achieve this sample size, they will invite around 1000 women in the antenatal exposure and the comparator cohort. The researchers will assess the recruitment rate 4-6 months into the study. If they are not achieving the expected recruitment, they will increase the number of women who are invited for the study. For example, to increase the recruitment for the comparator cohort, the researchers will invite four women for every index child in the antenatal exposure cohort (two on either side of birth of the index infant). Timetable The researchers will commence the study in May 2021 after obtaining ethics and HRA approval and recruiting the study personnel. The study set up including setting the data collection will complete by April 2021. Recruitment will commence from May 2021 and finish by April 2022. The developmental assessment using parental ASQ questionnaires at 18 months of age will last between August 2021 and July 2022. The researchers will undertake the data analysis, report writing and dissemination from July 2022 to October 2022. The study management committee will meet weekly during the initial stages of the study and will then meet monthly in the later stages to conduct the study.
Intervention type	Other
Primary outcome measure	Child development measured using the mean Ages and Stages Questionnaire (ASQ-3) total score at 21-24 months old
Secondary outcome measures	1. Proportion with one or more ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 2. Proportion of ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 3. Child development measured using the Mean Ages and Stages Questionnaire: Social-Emotional (ASQ-SE-2) total score and the proportion of ASQ-SE-2 total scores above the established cut-offs which identify possible developmental delay, measured at 21-24 months old 4. Respiratory symptoms measured using the mean Liverpool Respiratory Symptoms Questionnaire (LRSQ) total score at 21-24 months old 5. Frequency of health care usage measured using a non-validated questionnaire at 21-24 months old
Overall study start date	17/12/2020
Completion date	17/12/2023

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	Planned Sample Size: 520; UK Sample Size: 520
Key inclusion criteria	For the coronavirus-exposed cohort, any term (≥37 weeks gestation) baby: 1. Born to women who had confirmed coronavirus infection between 14 and 36 weeks of pregnancy will form the antenatal exposure cohort OR 2. Who had confirmed coronavirus infection within 28 days of birth will form the neonatal exposure cohort The comparator cohort will include any term baby: 1. Who did not have coronavirus infection within 28 days of birth AND 2. Born to women who did not have coronavirus infection during pregnancy in the same period as the antenatal exposure cohort
Key exclusion criteria	1. Children born prematurely at less than 37 weeks gestation 2. Children with a major congenital anomaly 3. Children born following multiple pregnancies
Date of first enrolment	16/11/2021
Date of final enrolment	28/02/2023

Locations

Countries of recruitment

England
Guernsey
United Kingdom
Wales

Study participating centres

Aneurin Bevan University Health Board

Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom

The Grange University Hospital

Caerleon Road
Cwmbran
NP44 8YN
United Kingdom

Queens Hospital

Rom Valley Way
Romford
RM7 0AG
United Kingdom

Barnsley Hospitals

118 Gawber Road
Barnsley
S75 2PS
United Kingdom

Newham General Hospital

Glen Road
London
E13 8SL
United Kingdom

Royal London Hospital

Whitechapel
London
E1 1BB
United Kingdom

Whipps Cross Hospital

Whipps Cross Road
London
E11 1NR
United Kingdom

Bedford Hospital

Icash Bedford Hospital
Kempston Road
Bedford
MK42 9DJ
United Kingdom

Luton & Dunstable Hospital

Lewsey Road
Luton
LU4 0DZ
United Kingdom

Birmingham Womens Hospital

Metchley Park Road
Birmingham
B15 2TG
United Kingdom

Bolton Royal Hospital

Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

Bradford Royal Infirmary

Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Stoke Mandeville Hospital

Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

Rosie Hospital

Robinson Way
Cambridge
CB2 0QQ
United Kingdom

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Chelsea & Westminster Hospital

369 Fulham Road
London
SW10 9NH
United Kingdom

West Middlesex University Hospital

Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Countess of Chester Hospital

Countess of Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom

Croydon University Hospital

London Road
Croydon
CR7 7YE
United Kingdom

Doncaster Royal Infirmary

Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Bassetlaw District General Hospital

Kilton Hill
Worksop
S81 0BD
United Kingdom

Dorset County Hospital

Dorset County Hospital
Princes Street
Dorchester
DT1 1TS
United Kingdom

Lister Hospital

Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Lancashire Women and Newborn Centre

Burnley General Hospital
Casterton Ave
Burnley
BB10 2PQ
United Kingdom

St Helier Hospital

Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Epsom General Hospital

Dorking Road
Epsom
KT18 7EG
United Kingdom

George Eliot Hospital

College Street
Nuneaton
CV10 7DJ
United Kingdom

Gloucestershire Royal Hospital

Great Western Road
Gloucester
GL1 3NN
United Kingdom

The Great Western Hospital

Marlborough Road
Swindon
SN3 6BB
United Kingdom

St Thomas' Hospital

Westminster Bridge Road
London
SE1 7EH
United Kingdom

Evelina Children's Hospital

Lambeth Palace Road
London
SE1 7EH
United Kingdom

Homerton University Hospital

Homerton Row
London
E9 6SR
United Kingdom

St Mary's Hospital

Praed Street
London
W2 1NY
United Kingdom

Queen Charlotte's and Chelsea Hospital

Du Cane Rd
London
W12 0HS
United Kingdom

Kings College Hospital

Mapother House
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom

Princess Royal University Hospital

Farnborough Common
Orpington
BR6 8ND
United Kingdom

Royal Preston Hospital

Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Queen Elizabeth Hospital

Woolwich Stadium Road
Woolwich
London
SE18 4QH
United Kingdom

University Hospital Lewisham

Lewisham High Street
London
SE13 6LH
United Kingdom

Liverpool Womens Hospital

Crown Street
Liverpool
L8 7SS
United Kingdom

Northwick Park Hospital

Watford Road
Harrow
HA1 3UJ
United Kingdom

Tunbridge Wells Hospital

The Tunbridge Wells Hospital
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
United Kingdom

Wythenshawe Hospital

Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

St Marys Hospital

Oxford Road
Manchester
M13 9WL
United Kingdom

Medway Maritime Hospital

Windmill Road
Gillingham
ME7 5NY
United Kingdom

Leighton Hospital

Leighton
Crewe
CW1 4QJ
United Kingdom

Pinderfields General Hospital

Aberford Road
Wakefield
WF1 4DG
United Kingdom

Princess Royal Maternity Hospital

16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Royal Hospital for Sick Children (Glasgow)

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Royal Alexandra Hospital

Corsebar Road
Paisley
PA2 9PN
United Kingdom

Queen Elizabeth University Hospital

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Princess Elizabeth Hospital, Le Vanquiedor

Rue Mignot
St Martins
GY4 6UU
Guernsey

Norfolk & Norwich University Hospital

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Southmead Hospital

Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom

Hinchingbrooke Hospital

Hinchingbrooke Park
Huntingdon
PE29 6NT
United Kingdom

Peterborough City Hospital

Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom

Oldham Care Organisation - Nmp

Butler Green House
Wallis Street
Chadderton
Oldham
OL9 8NG
United Kingdom

Nottingham City Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Queens Medical Centre

Nottingham University Hospital
Derby Road
Nottingham
NG7 2UH
United Kingdom

Queen Alexandra Hospital

Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Royal Berkshire Hospital

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Royal Cornwall Hospital (treliske)

Treliske
Truro
TR1 3LJ
United Kingdom

Royal Free Hospital

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Barnet Hospital

Wellhouse Lane
Barnet
EN5 3DJ
United Kingdom

Royal Surrey County Hospital Guildford

Egerton Road
Guildford
GU2 7XX
United Kingdom

Royal United Hospital

Combe Park
Bath
BA1 3NG
United Kingdom

New Cross Hospital Royal Wolverhampton

Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Birmingham City Hospital

Dudley Road
Birmingham
B18 7QH
United Kingdom

Sheffield Childrens Hospital

Western Bank
Sheffield
S10 2TH
United Kingdom

Jessops Wing

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Musgrove Park Hospital (taunton)

Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Warwick Hospital

Lakin Road
Warwick
CV34 5BW
United Kingdom

St Georges Hospital

Blackshaw Road
London
SW17 0QT
United Kingdom

Whiston Hospital

St. Helens & Knowsley Hospital
Warrington Road
Prescot
L35 5DR
United Kingdom

Stepping Hill Hospital

Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom

Hillingdon Hospital

Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Leeds General Infirmary

Great George Street
Leeds
LS1 3EX
United Kingdom

St James's University Hospital NHS Trust

St James's University Hospital
Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

The Royal Victoria Infirmary

Queen Victoria Road
Newcastle upon Tyne
TS1 4LP
United Kingdom

University College London Hospitals NHS Foundation Trust

250 Euston Road
London
NW1 2PG
United Kingdom

Southampton

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Princess Anne Hospital

Coxford Road
Southampton
SO16 5YA
United Kingdom

Heartlands Hospital

Bordesley Green East
Bordesley Green
Birmingham
B9 5ST
United Kingdom

Good Hope Hospital

Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

St Michaels Hospital

St. Michaels Hospital
Hayle
TR27 4JA
United Kingdom

University Hospital Coventry & Warwickshire

Clifford Bridge Road
Walsgrave
Coventry
CV2 2DX
United Kingdom

St Marys Maternity Unit

Poole Hospital
St Mary's Rd
Poole
BH15 2BH
United Kingdom

Royal Derby Hospital

Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Leicester Royal Infirmary

Infirmary Square
Leicester
LE1 5WW
United Kingdom

St Richards Hospital Laboratory

St. Richards Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom

Royal Alexandra Children's Hospital

Eastern Road
Brighton
BN2 5BE
United Kingdom

Worthing Hospital

Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Warrington Hospital (site)

Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
United Kingdom

Watford General Hospital

60 Vicarage Road
Watford
WD18 0HB
United Kingdom

The Whittington Hospital

Highgate Hill
London
N19 5NF
United Kingdom

Arrowe Park Hospital (site)

Arrowe Park Hospital
Arrowe Park Road
Wirral
CH49 5PE
United Kingdom

The Worcestershire Royal Hospital

Newtown Road
Worcester
WR5 1ZL
United Kingdom

Scarborough General Hospital (alliance Medical Scanning)

Scarborough Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

York Hospital

Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor information

University of Bristol
University/education

Research and Enterprise
1 Cathedral Square
Bristol
BS1 5DD
England
United Kingdom

Phone	+44 (0)1174284011
Email	research-governance@bristol.ac.uk
Website	http://bristol.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Charity

Action Medical Research; Grant Codes: GN2905
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		01/09/2022	17/01/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

17/01/2023: Publication reference added.
14/10/2022: The recruitment start date was changed from 10/09/2022 to 16/11/2021.
28/04/2022: Trial's existence confirmed by the NIHR.