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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT06087666
Eligibility Criteria:
Inclusion Criteria For infants :
1. Birth weight at or below 1500 g or gestational age at or below 34 weeks.
2. Any other peri-neonatal condition anticipating NICU specialised care.
3. Admission for at least 7 days
4. Decision to provide full life support.
Inclusion Criteria For Adults
1. Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
2. Active involvement in care for their infant at least a 7 day-period
3. No intellectual or language barriers\[A\] to understanding
4. At least one primary caregivers involved in training \[B\]
5. Signed informed consent
Exclusion Criteria For Children:
1. Decision not to provide full life support
2. Critical illness unlikely to survive
3. Scheduled for early transfer to another non-FICare hospital (expected hospital stay \<7days)
Exclusion Criteria for Parents:
1. Intellectual handicaps that makes difficult learning-understanding
2. Communication cannot be established even with translator
3. Mental, psychiatric problems or under legal supervision
4. Newborn under guardianship of social services
5. Lack of parental signed informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Weeks
Maximum Age:
1 Year
Study:
NCT06087666
Study Brief:
Protocol Section:
NCT06087666