MedTrace Logo

Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

NCT06087666 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Adelina Pellicer, MD · Hospital Universitario La Paz

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
0 Weeks
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087666 on ClinicalTrials.gov