The babies’ longitudinal outcomes, ‘omics, and milestones study

Prediction of NICU babies’ longitudinal health, neurodevelopmental, and educational outcomes from a multiomics data study (BLOOMS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15896464

Enrollment

3225

Registered

2025-07-01

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Babies currently admitted to the tertiary NICU for at least 48 hours Neonatal Diseases

Interventions

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 assessme

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. There is no adult with parental responsibility who can consent in English 2. Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

England, United Kingdom

Contacts

Public ContactHeather Pierce

hhp24@cam.ac.uk+44 (0)1223769096

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026