Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Preterm Clinical Trial

— RISEinFAMILY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087666
• Other study ID #: 101007922
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Adelina Pellicer, MD
• Phone: 617316799
• Email: adelina.pellicer[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Preterm

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Countries where clinical trial is conducted

Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term neurodevelopment: Proportion of infants who survive without neurodevelopmental disabilities at 24 months		Through study completion (average of 24 months)
Other	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)
Other	Mid-term infant's general health:	proportion of infants using health system facilities after discharge	Through study completion (average of 24 months)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	RISEinFAMILY implementation:	proportion of families completing basic and advanced training levels (observed vs expected).	Through study completion (average of 24 months)
Primary	RISEinFAMILY implementation:	Average time to complete basic and advanced training levels (observed vs expected)	Through study completion (average of 24 months)
Primary	RISEinFAMILY implementation:	Average time of kangaroo care per day	Through study completion (average of 24 months)
Primary	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	Reported adverse event rate per 1000 patients/day		Through study completion (average of 24 months)
Secondary	Feeding patterns at discharge:	proportion of infants on exclusive breastfeeding	Through study completion (average of 24 months)
Secondary	Brestfeeding rates at discharge:	Number of patients with no breastfeeding	Through study completion (average of 24 months)
Secondary	Brestfeeding rates at discharge:	Number of patients with <50% of intake	Through study completion (average of 24 months)
Secondary	Brestfeeding rates at discharge:	Number of patients with >50% of intake	Through study completion (average of 24 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Feeding patterns at discharge:	Day of life (DOL) to complete oral feeding (nasogastric tube removed)	Through study completion (average of 24 months)
Secondary	Feeding patterns at discharge:	day of life (DOL) to reach full enteral nutrition (>130 mL/K/day)	Through study completion (average of 24 months)
Secondary	Feeding patterns at discharge:	DOL at discharge	Through study completion (average of 24 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Feeding patterns at discharge:	postmenstrual age (PMA) to complete oral feeding (nasogastric tube removed)	Through study completion (average of 24 months)
Secondary	Feeding patterns at discharge:	postmenstrual age (PMA) to reach full enteral nutrition (>130 mL/K/day)	Through study completion (average of 24 months)
Secondary	Feeding patterns at discharge:	postmenstrual age (PMA) at discharge	Through study completion (average of 24 months)