Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Not Applicable

Recruiting

• Conditions: Preterm
• Interventions: Procedure: FICare

• Registration Number: NCT06087666
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-26
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FICare intervention	FICare	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).

Primary Outcome Measures

Name	Time	Method
RISEinFAMILY implementation:	Through study completion (average of 24 months)	Average time of kangaroo care per day
Short-term health infant's outcomes	Through study completion (average of 24 months)	proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission.

Secondary Outcome Measures

Name	Time	Method
Feeding patterns at discharge:	Through study completion (average of 24 months)	postmenstrual age (PMA) at discharge
Parental psychological health	Through study completion (average of 24 months)	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.
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)
Reported adverse event rate per 1000 patients/day	Through study completion (average of 24 months)
Brestfeeding rates at discharge:	Through study completion (average of 24 months)	Number of patients with \>50% of intake
Satisfaction and self-care of professionals measured by surveys	Through study completion (average of 24 months)	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

Trial Locations

Locations (2)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Gazi University; 🇹🇷 Ankara, Turkey