Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

NCT06087666 | Unknown

• 1 other identifier: 101007922
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 2

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.

Conditions

Preterm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Reported adverse event rate per 1000 patients/day

  Through study completion (average of 24 months)

• Feeding patterns at discharge:

  Through study completion (average of 24 months)

• Brestfeeding rates at discharge:

  Through study completion (average of 24 months)

• Brestfeeding rates at discharge:

  Through study completion (average of 24 months)

• Brestfeeding rates at discharge:

  Through study completion (average of 24 months)

Other Outcomes (16)

• 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:

  Through study completion (average of 24 months)

• Mid-term infant's general health:

  Through study completion (average of 24 months)

Study Arms (2)

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).

Procedure: FICare

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.

Interventions

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

FICare intervention

Eligibility Criteria

• Age: 0 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight at or below 1500 g or gestational age at or below 34 weeks.
• Any other peri-neonatal condition anticipating NICU specialised care.
• Admission for at least 7 days
• Decision to provide full life support.
• Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
• Active involvement in care for their infant at least a 7 day-period
• No intellectual or language barriers\[A\] to understanding
• At least one primary caregivers involved in training \[B\]
• Signed informed consent

You may not qualify if:

• Decision not to provide full life support
• Critical illness unlikely to survive
• Scheduled for early transfer to another non-FICare hospital (expected hospital stay \<7days)
• Intellectual handicaps that makes difficult learning-understanding
• Communication cannot be established even with translator
• Mental, psychiatric problems or under legal supervision
• Newborn under guardianship of social services
• Lack of parental signed informed consent

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (2)

Hospital Universitario La Paz

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

Gazi University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 38594733 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adelina Pellicer, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelina Pellicer, MD

CONTACT

617316799; adelina.pellicer@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped wedge cluster controlled trial

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: October 18, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

ES (1); TU (1)