Status:
UNKNOWN
Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
Preterm
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active partic...
Eligibility Criteria
Inclusion
- Inclusion Criteria For infants :
- Birth weight at or below 1500 g or gestational age at or below 34 weeks.
- Any other peri-neonatal condition anticipating NICU specialised care.
- Admission for at least 7 days
- Decision to provide full life support.
- Inclusion Criteria For Adults
- Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
- Active involvement in care for their infant at least a 7 day-period
- No intellectual or language barriers\[A\] to understanding
- At least one primary caregivers involved in training \[B\]
- Signed informed consent
- Exclusion Criteria For Children:
- Decision not to provide full life support
- Critical illness unlikely to survive
- Scheduled for early transfer to another non-FICare hospital (expected hospital stay \<7days)
- Exclusion Criteria for Parents:
- Intellectual handicaps that makes difficult learning-understanding
- Communication cannot be established even with translator
- Mental, psychiatric problems or under legal supervision
- Newborn under guardianship of social services
- Lack of parental signed informed consent
Exclusion
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06087666
Start Date
February 1 2023
End Date
December 1 2024
Last Update
October 18 2023
Active Locations (2)
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1
Hospital Universitario La Paz
Madrid, Spain, 28046
2
Gazi University
Ankara, Turkey (Türkiye), 06560