Family integrated care for preterm infants in neonatal intensive care units

Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program

This study is testing a new way for parents to care for their preterm babies in the NICU to see if it helps improve their health compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 0 Weeks to 1 Year
• Sex: All
• Sponsor: Instituto de Investigación Hospital Universitario La Paz (Academic / other)
• Locations: 2 sites (Madrid and 1 other locations)
• Trial ID: NCT06087666 on ClinicalTrials.gov

What this trial studies

This international, multi-centre trial aims to implement a Family Integrated Care (FICare) model in neonatal intensive care units (NICUs) to enhance parental involvement as primary caregivers for high-risk newborns. The study will compare the outcomes of infants receiving FICare against those receiving standard NICU care, focusing on short-term health outcomes for infants with prolonged hospital stays. The trial employs a stepped wedge cluster controlled design to assess the effectiveness of this tailored approach across various cultural settings.

Who should consider this trial

Good fit: Ideal candidates include preterm infants weighing 1500 grams or less or born at 34 weeks gestation or earlier, who are expected to stay in the NICU for at least 7 days.

Not a fit: Patients who are not receiving full life support or are critically ill with a low chance of survival may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve health outcomes for preterm infants by fostering stronger parental involvement in their care.

How similar studies have performed: Previous studies have shown promising results with family-centered care approaches in NICUs, suggesting that this model could be effective.

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

Where this trial is running

Madrid and 1 other locations

• Hospital Universitario La Paz — Madrid, Spain (Active_not_recruiting)
• Gazi University — Ankara, Turkey (Recruiting)

Study contacts

• Principal investigator: Adelina Pellicer, MD — Hospital Universitario La Paz
• Study coordinator: Adelina Pellicer, MD

Conditions Preterm