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Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Not Recruiting
1 years and younger
All
Phase N/A

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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.

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

Study details
    Preterm

NCT06087666

Instituto de Investigación Hospital Universitario La Paz

30 January 2026

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