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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FICare intervention | Experimental | 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). |
|
| control intervention | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FICare | Procedure | 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 |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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: | Proportion of infants maintaining adequate growth pattern during the first 12 months after birth |
Inclusion Criteria For infants :
Inclusion Criteria For Adults
Exclusion Criteria For Children:
Exclusion Criteria for Parents:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adelina Pellicer, MD | Contact | 617316799 | adelina.pellicer@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Adelina Pellicer, MD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Active, not recruiting | Madrid | 28046 | Spain | ||
| Gazi University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38594733 | Derived | Alferink MT, Moreno-Sanz B, Cabrera-Lafuente M, Ergenekon E, de Haan TR, van Kempen AAMW, Lakhwani J, Rabe H, Zaharie GC, Pellicer A; RISEinFAMILY Consortium (European Union, MSCA-RISE-H2020). RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial. Trials. 2024 Apr 10;25(1):248. doi: 10.1186/s13063-024-08043-7. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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stepped wedge cluster controlled trial
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| 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) |
| Through study completion (average of 24 months) |
| Mid-term infant's general health: | proportion of infants using health system facilities after discharge | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded: For neonates: Number of days in hospital | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded: For neonates: Number of days on different levels of care | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded: For neonates: Hospital readmissions (number of episodes) | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded: For neonates: Frequentation of emergency service | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded: For carers : Number of siblings on care | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : Relation to the newborn on care: parent, legal tutor, other family member | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : average hours/day on care | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : overnight stay at hospital/nearby: number of overnight stays | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : Payment for overnight stay | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : travel to hospital for care: expenses/travel, N of trips | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : other dependents under your care: N of dependents | Through study completion (average of 24 months) |
| Economic impact | Measure levels of resources associated with FICare implementation: The following data will be recorded for carers : helps received for dependents | Through study completion (average of 24 months) |
| Economic impact | cost-effectiveness estimates compareing current care to previous care model. The cost-effectiveness analysis of the FICare implementation will be carried out using a decision-analytical model that will be developed and populated with costs and effectiveness data from the pilot studies. For each FICare implementation site the cost-effectiveness of the intervention will be estimated as follows: ICER= ∆C/∆E where: ICER - incremental cost-effectiveness ratio.
| Through study completion (average of 24 months) |
| Recruiting |
| Ankara |
| 06560 |
| Turkey (Türkiye) |
|
| D000091642 | Urogenital Diseases |