Clinical trial NCT06087666: Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units
Official title: Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped wedge cluster controlled trial
Primary purpose: PREVENTION

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 participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard NICU care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.


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

Primary outcomes:
measure: RISEinFAMILY implementation:
timeFrame: Through study completion (average of 24 months)
measure: RISEinFAMILY implementation:
timeFrame: Through study completion (average of 24 months)
measure: RISEinFAMILY implementation:
timeFrame: Through study completion (average of 24 months)
measure: Short-term health infant's outcomes
timeFrame: Through study completion (average of 24 months)
Secondary outcomes:
measure: Reported adverse event rate per 1000 patients/day
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Brestfeeding rates at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Brestfeeding rates at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Brestfeeding rates at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Parental psychological health
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Proportion of infants diagnosed of (at 36 weeks PMA or discharge): bronchopulmonary dysplasia, oxygen dependency, severe retinopathy of prematurity (grade 3 or need for treatment), nosocomial infection necrotising enterocoli
timeFrame: Through study completion (average of 24 months)
measure: Satisfaction and self-care of professionals measured by surveys
timeFrame: Through study completion (average of 24 months)
measure: Satisfaction and self-care of professionals measured by surveys
timeFrame: Through study completion (average of 24 months)
measure: Satisfaction and self-care of professionals measured by surveys
timeFrame: Through study completion (average of 24 months)
measure: Satisfaction and self-care of professionals measured by surveys
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
measure: Feeding patterns at discharge:
timeFrame: Through study completion (average of 24 months)
Other outcomes:
measure: Long-term neurodevelopment: Proportion of infants who survive without neurodevelopmental disabilities at 24 months
timeFrame: Through study completion (average of 24 months)
measure: Mid-term infant's general health:
timeFrame: Through study completion (average of 24 months)
measure: Mid-term infant's general health:
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
measure: Economic impact
timeFrame: Through study completion (average of 24 months)
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Hospital Universitario La Paz
name: Adelina Pellicer, MD
role: PRINCIPAL_INVESTIGATOR
References: