The Generation Study

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 105000

Inclusion Criteria

Current participant inclusion criteria as of 05/12/2023:
1. Mother / birthing parent over the age of 16
2. Mother / birthing parent must have parental responsibility for the baby
3. Singleton birth

For those with complicated births or early postnatal periods, for example where admission to NICU is necessary, final sampling decision will be made on a case-by-case basis at the discretion of the research staff and with the NHS clinical team.

Previous participant inclusion criteria as of 07/11/2023 to 05/12/2023:
1. Mother / birthing parent aged 16 and over
2. Mother / birthing parent must have parental responsibility for the baby
3. Singleton birth
4. Babies born after 36 weeks, for whom a cord blood sample can be obtained*
5. Babies born at home are included if an individual with legal parental responsibility is willing to bring the baby back to the study site for sample collection

*For those with complicated births or early postnatal periods, for example where admission to NICU is necessary, final sampling decision will be made on a case-by-case basis with input from the NHS clinical team.

Previous participant inclusion criteria:
1. Mother / birthing parent over the age of 16
2. Mother / birthing parent must have parental responsibility for the baby
3. Singleton birth
4. Babies born after 36 weeks, for whom a cord blood sample can be obtained*
5. Babies born at home are included if an individual with legal parental responsibility is willing to bring the baby back to the study site for sample collection

*For those with complicated births or early postnatal periods, for example where admission to NICU is necessary, final sampling decision will be made on a case-by-case basis with input from the NHS clinical team.

Exclusion Criteria

Current participant exclusion criteria as of 05/12/2023:
1. Mother / birthing parent under 16
2. Mother / birthing parent who will not have parental responsibility for the baby (Babies who are being adopted)
3. Mother / birthing parent lacking the capacity to provide informed consent for any reason
4. Mother / birthing parent who does not give birth in one of the recruiting hospitals
5. Mother / birthing parent who does not have an NHS number
6. Mother / birthing parent who is serving time in prison

Previous participant exclusion criteria:
1. Mother / birthing parent under 16
2. Mother / birthing parent who will not have parental responsibility for the baby (Babies who are being adopted)
3. Mother / birthing parent who does not have a fixed UK address where they reside (prisoners, people in long-term care, people requiring refuge, people of no fixed abode)
4. Mother / birthing parent lacking the capacity to provide informed consent for any reason
5. Mother / birthing parent who does not give birth in one of the recruiting hospitals
6. Mother / birthing parent who does not have an NHS number

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical utility of genomic newborn screening measured using the number of screen-identified diagnoses likely to benefit from the intervention compared to the standard of care alone. The primary outcome measure will have two timepoints as follows:<br>1. Firstly in Spring / Summer 2024, or if recruitment is slower than expected, following recruitment of 20,000 babies<br>2. Secondly at the end of 2025, or if recruitment is slower than expected, 6 months after recruitment of the 100,000th baby. The 6-month time lag is essential due to the length of time taken for babies to receive a diagnostic outcome following a screen-positive result. Given that some babies will still not have a confirmed diagnosis at that point, the intention is to continue intermittent monitoring over a longer time period.<br>

Secondary Outcome Measures