Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Study Overview
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Brief Summary
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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.

Official Title
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Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program

Conditions
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Preterm

Intervention / Treatment
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* Procedure: FICare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: stepped wedge cluster controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FICare intervention<br>FICare implementation model will be demonstrated by setting 5 pilots in non-FICare-experienced NICUs from NL, TR, RO, UK, ZM (AMC, GU, CLUJ, UHS, and UNZA, partners, respectively) and 2 pilots in clinical sites who have recently implemented FICare from ES and NL (SERMAS and OLVG). | Procedure: FICare<br>* 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<br>|
| No Intervention: control intervention<br>A cohort of patients born at the non-FICare clinical sites (AMC, GU, CLUJ, UHS, and UNZA) from the start of the study (November 2022) to the time assigned to start the intervention. A 3-month washout period will be established for staff training and site readiness. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RISEinFAMILY implementation: | proportion of families completing basic and advanced training levels (observed vs expected). | Through study completion (average of 24 months) | 
| RISEinFAMILY implementation: | Average time to complete basic and advanced training levels (observed vs expected) | Through study completion (average of 24 months) | 
| RISEinFAMILY implementation: | Average time of kangaroo care per day | Through study completion (average of 24 months) | 
| Short-term health infant's outcomes | proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission. | Through study completion (average of 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported adverse event rate per 1000 patients/day |  | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | proportion of infants on exclusive breastfeeding | Through study completion (average of 24 months) | 
| Brestfeeding rates at discharge: | Number of patients with no breastfeeding | Through study completion (average of 24 months) | 
| Brestfeeding rates at discharge: | Number of patients with <50% of intake | Through study completion (average of 24 months) | 
| Brestfeeding rates at discharge: | Number of patients with >50% of intake | Through study completion (average of 24 months) | 
| Parental psychological health | 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 | Through study completion (average of 24 months) | 
| Parental psychological health | Anxiety and depression symptoms will be measured using the Four Item Patient health (PHQ-4). Scale ranges from 0 to 3, higher scores indicate worse outcomes | Through study completion (average of 24 months) | 
| Parental psychological health | Postnatal depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS). Scale ranges from 0 to 3, higher scores indicate worse outcome. | Through study completion (average of 24 months) | 
| Parental psychological health | Maternal self-efficacy will be measured using the Perceived Maternal Parenting Self-Efficacy (PMP S-E). Scale ranges from 0 to 3, higher scores indicate better outcome | Through study completion (average of 24 months) | 
| Parental psychological health | Maternal-to-infant-bonding scale will be measured using the Maternal-to-Infant Bonding Scale. Score ranges 0 to 3. For items 1,2 and 6, higher scores correlate to better outcomes; for items 2, 3, 5, 7 and 8, higher scores correlate to a worse outcome. | Through study completion (average of 24 months) | 
| Parental psychological health | Resilience will be measured Brief Resilience Scale. Scale ranges from 0 yo 6. For items 4, 7, 9, 12, 17, 18, 19 and 21, higher scores indicate a better outcome. For items 1, 2, 3, 5, 6, 8, 10, 11, 13, 14, 15, 16m 20 and 22 a higher score indicates a worse outcome. | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | Day of life (DOL) to complete oral feeding (nasogastric tube removed) | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | day of life (DOL) to reach full enteral nutrition (>130 mL/K/day) | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | DOL at discharge | Through study completion (average of 24 months) | 
| 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 | 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. | Through study completion (average of 24 months) | 
| Satisfaction and self-care of professionals measured by surveys | burnout symptoms will be measured using the Maslach burnout inventory human services survey (MBI-HSS). Scale ranges from 0 to 6. For Items 4, 7, 9, 12, 17, 18, 19 and 21, higher scores indicate a better outcome. For items 1, 2, 3, 5, 6, 8, 10, 11, 13, 14, 15, 16, 20 and 22, higher scores indicate a worse outcome. | Through study completion (average of 24 months) | 
| Satisfaction and self-care of professionals measured by surveys | post-traumatic stress will be measured using (post traumatic stress survey (PTSD-8). Scale ranges from 0 to 3, higher scores indicate worse outcomes | Through study completion (average of 24 months) | 
| Satisfaction and self-care of professionals measured by surveys | Work and wellbeing will be measured using Unwes-9 work and well-being survey (UWES). Scale ranges from 0 to 6, a higher score indicates a better outcome | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | postmenstrual age (PMA) to complete oral feeding (nasogastric tube removed) | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | postmenstrual age (PMA) to reach full enteral nutrition (>130 mL/K/day) | Through study completion (average of 24 months) | 
| Feeding patterns at discharge: | postmenstrual age (PMA) at discharge | Through study completion (average of 24 months) |