Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units (RISEinFAMILY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm
• Intervention / Treatment: Procedure: FICare

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adelina Pellicer, MD; Phone Number: 617316799; Email: adelina.pellicer@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Hospital Universitario La Paz
• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Gazi University
    • Contact: Nuriye Ebru Ergenekon, Prof. Dr; Phone Number: +90 312 202 6032; Email: ebruer@gazi.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FICare intervention; 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; 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
No Intervention: control 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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	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.; C - difference in mean costs for post- and pre-intervention.; E - difference in mean effectiveness outcomes for post-and pre-intervention.	Through study completion (average of 24 months)

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Adelina Pellicer, MD, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 101007922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No