The babies’ longitudinal outcomes, ‘omics, and milestones study
| ISRCTN | ISRCTN15896464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15896464 |
| IRAS number | 344546 |
| Secondary identifying numbers | The Wellcome Trust 312471/Z/24/Z |
- Submission date
- 23/06/2025
- Registration date
- 01/07/2025
- Last edited
- 01/07/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
We know that some babies who need neonatal care can face challenges in their later health, learning, and development. We aim to understand which babies might benefit from extra help at an early age. BLOOMS is a new research project designed to understand how we can better support children who need neonatal care as they grow.
The aims of BLOOMS are to:
1. Improve how we use information from newborn genetics alongside other information to make earlier and more accurate diagnoses
2. Discover early warning signs that could help doctors and teachers provide support before problems become serious in childhood
3. Understand the causes of poor health and developmental outcomes, so we can work to improve those outcomes in young children
Who can participate?
We are inviting families with a baby who is currently admitted to a specialist NICU in Cambridge, Luton, or Norwich to take part. The baby has to be admitted to the NICU for 48 hours or more, and has to have an adult with parental responsibility available to sign consent.
What does the study involve?
Parents will be asked to read and sign a consent form for themselves and their baby
Parents will be asked to provide their and their baby’s name, date of birth, NHS number, and contact details and allow us to store them.
Parents will be asked to complete electronic questionnaires to provide some more information about themselves and their family, such as medical history, schooling, work, etc.
Soon after the consent form is signed, the clinical team will obtain a small blood sample from the baby. A member of the research team will also arrange for a blood sample to be collected from each parent who is happy to take part.
Before the baby is discharged from the NICU, the clinical team will obtain another small blood sample from them as well as a poo sample from their nappy.
After the baby is discharged from the NICU, families will be contacted when the baby is 9 months old, then 2, 4, and 5 years old for developmental assessments and parent questionnaires that can be done easily at home.
Families will be invited to bring the baby to Cambridge when they are 3 years old for a visit that includes a full developmental assessment, measurements of height/weight and an EEG (a painless test that records the brain's electrical activity). At the same visit another small blood sample and a stool sample from the baby will be arranged.
We will ask for consent to have access to the baby’s health records and to access information collected about them through health and education records until they turn 16 years old.
We will also ask to access the health records of parents who were pregnant, from before birth until 1 year after birth.
Families' active involvement in the study is for 5 years. Information collected about babies through health and education records will be accessed by the study until they turn 16 years old.
What are the possible benefits and risks of participating?
There may be extra information arising from the study that could help the clinical team looking after your child. Your child will be essential to the study’s success and will receive annual birthday presents from the study team.
Taking part in BLOOMS is designed to help other families whose babies need neonatal care in the future, and to find ways of supporting children in the future.
There are no risks to the baby or to parents. Blood sampling can be uncomfortable; for young children samples are always taken by fully trained staff who will make the process as simple as possible.
Where is the study run from?
The study is being jointly run from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2025 to January 2042
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Prof. Catherine Aiken, cema2@cam.ac.uk
Contact information
Scientific, Principal Investigator
Department of Obstetrics and Gynaecology
University of Cambridge, Box 223
The Rosie Hospital and NIHR Cambridge Biomedical Research Centre
Cambridge
CB2 0SW
United Kingdom
 ORCID ID |
0000-0002-6510-5626 |
|---|---|
| Phone | +44 (0)1223333751 |
| cema2@cam.ac.uk |
Public
Box 116, Level 8
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom
| ORCID ID |
0009-0000-2545-1260 |
|---|---|
| Phone | +44 (0)1223769096 |
| hhp24@cam.ac.uk |
Study information
| Study design | Multicentre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Prediction of NICU babies’ longitudinal health, neurodevelopmental, and educational outcomes from a multiomics data study (BLOOMS) |
| Study acronym | BLOOMS |
| Study objectives | The rationale behind this study is to determine if we can use multiomics data from NICU babies to predict the early life antecedents of poor health and neurodevelopmental outcomes, including school readiness. Discovering early warning signs (biomarkers) could help doctors and teachers provide support before problems become serious, and understanding the root causes of poor health and developmental outcomes can enable us to work to prevent them. |
| Ethics approval(s) |
Not yet submitted 18/06/2025, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email not provided), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Babies currently admitted to the tertiary NICU for at least 48 hours |
| Intervention | For this observational study, families will be asked to consent to three study elements: (i) sampling of blood/stool for generation of multi-omic data, (ii) remote and in-person developmental assessments up to age 5, and (iii) permission for ongoing remote data linkage to routinely-collected sources until the child turns 16 years old. Families will actively participate in the study for up to 5 years, which will include two in-person study contacts: at recruitment in the NICU and when the child is 3 years old. They will also be asked to provide information and participate in remote study contacts at annual intermediate time-points. At all visits questionnaires will be used to collect a variety of types of information about the family (e.g. demographic information, socio-economic information, social support, parenting styles), family health and well-being (e.g. Edinburgh post-natal depression scores), and childhood development (e.g. CREDI or equivalent at various ages), including measures of language development and socio-emotional well-being. At the initial visit in the NICU, parental blood sampling will be undertaken by a member of the research team and the baby will have their initial blood sample taken by a member of the clinical team. A second blood sample will be taken from the baby by the clinical team at the next suitable opportunity. A stool sample will be obtained by the clinical team during routine care for the baby. When the baby is 9 months old, then 2, 4, and 5 years old, the family will be contacted to arrange developmental assessments and parent questionnaires that can be done easily at home. When the baby is 9 months old, electronic questionnaire links will be sent via the participant’s preferred method. At 2 years following birth, electronic questionnaire links will be sent via the participant’s preferred method. The study team will phone the parents to talk through arrangements for home recording of a parent and child playing together. Parents will also be sent a link to an online survey, which will include updates on key demographic and family information recorded at 9 months, as well as new parent-reported developmental measures, suitable for this age group (e.g. language development, including vocabulary, cognition development, motor development, social and emotional development and behavioural problems, and early autism traits). Parents will also be asked to complete questionnaires regarding their parental style and activities to support the child’s learning and development in the home, assessments of the child’s height and weight, as well as early childhood education and care provision. At an in-person developmental assessment at 3 years old, children will undergo standardised and validated developmental assessments. An EEG will be recorded in the resting state, with visual and audio stimuli (social and non-social), executive function and language tasks. A blood sample will be taken from the child by a suitably trained member of the research team with the assistance of other support team members and parents as required according to the study SOP. Parents will also be given a stool sampling kit at the in-person visit. Clear instructions will be provided by the study team on how to obtain a sample and post the kit back to the research team. At 4 and 5 years old, electronic questionnaire links will be sent via the preferred method of communication. Relevant medical data will be extracted from the locally held medical records of the baby and mother at birth and 9 months of age. Health and growth outcomes between birth and 16 years will be assessed via linkage to routinely collected data sources, including NHS (e.g. HES, primary data) and the national childhood measurement programme. Educational attainment aged 5 – 16 years will be assessed via linkage to the National Pupil database. |
| Intervention type | Other |
| Primary outcome measure | To discover links between biomarkers, genome, and long-term outcomes that can provide insight into fundamental developmental mechanisms, early origins of disease, and learning disability, using the following measures: 1. Whole genome sequences (WGS) from the baby and parents from blood samples obtained at the time of consent to NICU 2. Other multi-omic data from baby and parents, e.g. proteome, methylome, microbiome from samples obtained at time of consent to NICU 3. Demographic, socio-economic, family health and circumstances, other relevant life-style information measured using electronic questionnaires administered at time of consent in NICU, 9 months and 2, 3, 4, and 5 years 4. Developmental skills, abilities, and wellbeing measured via in-person and remote developmental assessments and questionnaires between birth and 5 years 5. Data extracted from the locally held medical records of the baby and mother at birth and 9 months of age 6. Health and growth outcomes measured via linkage to routinely-collected data sources, including NHS (e.g. HES, primary care data) and national childhood measurement programme between birth and 16 years |
| Secondary outcome measures | To stratify the risks of adverse educational outcomes using early markers: 1. Educational attainment is measured via linkage to the National Pupil database at age 5 to 16 years |
| Overall study start date | 18/06/2025 |
| Completion date | 01/01/2042 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 1 Day |
| Sex | Both |
| Target number of participants | 3225 |
| Key inclusion criteria | Inclusion criteria for babies: 1. Admitted to a tertiary-level neonatal unit (NICU) in the East of England 2. Admitted to a tertiary level NICU for ≥48 hours 3. Has an adult with parental responsibility available to sign consent Parents of babies will also be included in the study if they: 1. Have parental responsibility for the baby 2. Are aged 18 years or above 3. Are willing and able to give informed consent in English for participation in the study |
| Key exclusion criteria | 1. There is no adult with parental responsibility who can consent in English 2. Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 01/01/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Norwich
NR4 7UY
United Kingdom
Luton
LU4 0DZ
United Kingdom
Sponsor information
Hospital/treatment centre
Hill Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 217418 |
|---|---|
| research@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
University/education
School of Clinical Medicine
University of Cambridge
Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
England
United Kingdom
| Phone | +44 (0)1223769291 |
|---|---|
| researchgovernance@medschl.cam.ac.uk | |
| Website | http://cam.ac.uk |
|
"ROR" |
https://ror.org/013meh722 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2032 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and on the study website. |
| IPD sharing plan | The anonymised datasets generated during and/or analysed during the current study will be available upon request at the discretion of the chief investigator, Professor Catherine Aiken, cema2@cam.ac.uk. |
Editorial Notes
23/06/2025: Study's existence confirmed by the Wellcome Trust.
