Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT07021469
Eligibility Criteria:
Inclusion Criteria:
Parent inclusion criteria:
1. 18+ years
2. Has an infant diagnosed with a condition meeting the infant inclusion criteria on admission to the unit (see below)
3. Can give informed consent
Healthcare professional inclusion criteria:
1. Nursing professional working with or providing support to parents with infants diagnosed with a life limiting condition involved in the study
2. Part time, full time on UCLH neonatal unit
3. Any grade
Infant inclusion
In accordance with Together for short lives neonatal palliative care guidelines any parent who has an infant meeting the following criteria whilst on the neonatal unit will be eligible for the intervention:
Category 1: Life-threatening conditions for which curative treatment may be feasible but can fail Provision of palliative care services may be necessary when treatment fails or during an acute crisis, irrespective of the duration of threat to life. On reaching long-term remission or following successful curative treatment there is no longer a need for palliative care services. Examples: extreme prematurity, severe necrotising enterocolitis, congenital heart disease.
Category 2 Conditions where premature death is inevitable. There may be long periods of intensive treatment aimed at prolonging life and allowing participation in normal activities. Example: chromosomal abnormality, severe spina bifida, bilateral multi-cystic dysplastic kidneys, bilateral renal agenesis.
Category 3 Progressive conditions without curative treatment options Treatment is exclusively palliative and may commonly extend over many years. Example: skeletal dysplasia, severe neuromuscular disorders.
Category 4 Irreversible but non-progressive conditions causing severe disability, leading to susceptibility to health complications and likelihood of premature death. Example: severe hypoxic ischaemic encephalopathy.
Exclusion Criteria:
Parent exclusion criteria
1. \<18+ years
2. Acute mental health diagnosis e.g schizophrenia, psychosis
3. Substance abuse
4. Does not have an infant meeting inclusion criteria
5. Unable to provide consent
Healthcare professional exclusion criteria
1. not working with or providing support to parents with infants diagnosed with a life limiting condition
2. agency staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07021469
Study Brief:
Protocol Section:
NCT07021469