Alliance for Family Integrated Care Implementation in Neonatal Intensive Care Units

Launched by INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a special approach called the "Family Integrated Care Model" (FICare) in neonatal intensive care units (NICUs) for high-risk newborns. The goal is to see if involving parents more actively in their baby's care can lead to better health outcomes compared to standard care. This study is open to infants who are born very early (at or below 34 weeks) or have a low birth weight (1500 grams or less) and who will need to stay in the NICU for at least a week. Parents who are willing to spend time in the NICU and take part in their baby's care may also be eligible to participate.

If you join this trial, you can expect to be involved in your baby’s care, learning how to support them during their hospital stay. The trial is currently recruiting participants, and it's important for parents to be able to understand the care process and commit to being present for a significant part of the day. The study aims to see if more family involvement can improve the health and well-being of babies who need specialized care.

Gender

ALL

Eligibility criteria

• 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