Prediction of NICU babies’ longitudinal health, neurodevelopmental, and educational outcomes from a multiomics data study (BLOOMS)
Babies currently admitted to the tertiary NICU for at least 48 hours
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. Paren
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
1. There is no adult with parental responsibility who can consent in English 2. Does not meet inclusion criteria