Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Instituto de Investigación Hospital Universitario La Paz12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Preterm

Interventions

FICarePROCEDURE

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

Eligibility

Sex: ALLMin age: 0 WeeksMax age: 1 Year

Medical Language ↔ Plain English

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

Locations (2)

Hospital Universitario La Paz

Madrid, Spain

ACTIVE_NOT_RECRUITING

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

RISEinFAMILY implementation:

proportion of families completing basic and advanced training levels (observed vs expected).

Time frame: Through study completion (average of 24 months)

RISEinFAMILY implementation:

Average time to complete basic and advanced training levels (observed vs expected)

Time frame: Through study completion (average of 24 months)

RISEinFAMILY implementation:

Average time of kangaroo care per day

Time frame: 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.

Time frame: Through study completion (average of 24 months)

Secondary Outcomes

Reported adverse event rate per 1000 patients/day

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

proportion of infants on exclusive breastfeeding

Time frame: Through study completion (average of 24 months)

Brestfeeding rates at discharge:

Number of patients with no breastfeeding

Time frame: Through study completion (average of 24 months)

Brestfeeding rates at discharge:

Number of patients with \<50% of intake

Time frame: Through study completion (average of 24 months)

Central Contacts

Adelina Pellicer, MD

CONTACT

617316799 adelina.pellicer@salud.madrid.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Brestfeeding rates at discharge:

Number of patients with \>50% of intake

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

Day of life (DOL) to complete oral feeding (nasogastric tube removed)

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

day of life (DOL) to reach full enteral nutrition (\>130 mL/K/day)

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

DOL at discharge

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

postmenstrual age (PMA) to complete oral feeding (nasogastric tube removed)

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

postmenstrual age (PMA) to reach full enteral nutrition (\>130 mL/K/day)

Time frame: Through study completion (average of 24 months)

Feeding patterns at discharge:

postmenstrual age (PMA) at discharge

Time frame: Through study completion (average of 24 months)