Preterm
Conditions
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.
Interventions
PROCEDUREFICare
The Family Integrated Care (FICare) programme has been developed in a multicenter cluster randomised controlled trial, with 26 tertiary NICUs from Canada, Australia and New Zealand, comparing standard NICU care (which was mainly care by nurses) (891 infants) to FICare programme (895 infants). FICare model and showed that the involvement of parents in the direct care improved weight gain and increased breastfeeding rates in the preterm infants. In addition, their parents had lower rates of stress and anxiety. These results were confirmed in a cluster-randomised controlled trial. Subsequent studies carried out so far have shown promising positive effects on a variety of domains. Maturation profiles have been shown to accelerate with the FICare intervention as a shorter time to achieve exclusive enteral nutrition as well as oral nutrition has been shown in the preterm infants included in FICARE programmes compared to control babies
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
stepped wedge cluster controlled trial
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 1 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term health infant's outcomes | Through study completion (average of 24 months) | proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission. |
| RISEinFAMILY implementation: | Through study completion (average of 24 months) | proportion of families completing basic and advanced training levels (observed vs expected). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding patterns at discharge: | Through study completion (average of 24 months) | proportion of infants on exclusive breastfeeding |
| Brestfeeding rates at discharge: | Through study completion (average of 24 months) | Number of patients with no breastfeeding |
| Reported adverse event rate per 1000 patients/day | Through study completion (average of 24 months) | — |
| Parental psychological health | Through study completion (average of 24 months) | Parental stress will be measured using the abbreviated Pediatric Stress Scale for Pediatric Intensive Care Unit (PSS PICU). Scale ranges from 0 to 5, higher scores indicate worse outcomes |
| 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 | Through study completion (average of 24 months) | — |
| Satisfaction and self-care of professionals measured by surveys | Through study completion (average of 24 months) | Anxiety and depression symptoms will be measured using the anxiety and depression survey (PHQ-4). The scale ranges from 1 to 3. Higher scores indicate a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Long-term neurodevelopment: Proportion of infants who survive without neurodevelopmental disabilities at 24 months | Through study completion (average of 24 months) | — |
| Mid-term infant's general health: | Through study completion (average of 24 months) | Proportion of infants maintaining adequate growth pattern during the first 12 months after birth |
| Economic impact | Through study completion (average of 24 months) | Measure levels of resources associated with FICare implementation: The following data will be recorded: For neonates: Number of days in hospital |
Countries
Spain, Turkey (Türkiye)
Contacts
Primary ContactAdelina Pellicer, MD
Outcome results
None listed