Actively Recruiting
Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study
Led by Turku University Hospital · Updated on 2025-12-31
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of the Close Collaboration with Parents (CCP) intervention on the neonatal intensive care unit (NICU) environment and the long-term neurodevelopment and social-emotional growth of very preterm infants. This pilot study aims to test the measurement tools and determine sample size before a larger multicenter trial. The CCP intervention focuses on improving partnership between NICU staff and parents and enhancing parental involvement in infant care. The study involves two phases: before and after implementing the CCP training program. Initially, NICU staff provide routine care under standard practices. After the CCP training, all staff complete e-learning and bedside practices with mentoring to support family-centered care by improving communication and collaboration with parents. This behavioral intervention is delivered through a train-the-trainer model where local mentors guide staff. Participants will be monitored from enrollment until NICU discharge and up to 3 years of corrected age. Weekly assessments include auditory environment, parent presence, sleep quality, feeding type, and body weight. Additional evaluations include breastfeeding, parenting confidence, length of stay, brain MRI at term age, parent-infant interaction, cry diary, behavior questionnaires, and developmental scales. These measures help researchers understand the intervention's impact on infants' growth and development over time.
CONDITIONS
Brief Title
Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born below 32 weeks of gestation and/or weighing less than 1500 grams
- Infants receiving long-term follow-up at each study site
You will not qualify if you...
- Infant has any major anomalies
- Infants are triplets or higher order multiples
- Infant's condition is critical and survival is uncertain
- Parents cannot understand the informed consent form in Korean or Japanese
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks of postmenstrual age during NICU stay
Participants experience two phases: before and after the neonatal staff receive Close Collaboration with Parents training, which aims to improve family-centered care in the NICU by enhancing staff communication and support for parents.
Weekly visits for up to 40 weeks
Duration - Up to 3 years of corrected age
Participants are followed up with assessments of growth, neurodevelopment, and parent-infant interactions at multiple timepoints after NICU discharge.
Visits at 1 month, 6 months, 18 months, and 3 years of corrected age
Trial Site Locations
Total: 3 locations
1
Nagano Children's Hospital
Matsumoto, Nagano, Japan
Not Yet Recruiting
2
Kyoto University Hospital
Kyoto, Japan
Not Yet Recruiting
3
Korea University Anam Hospital NICU
Seoul, South Korea, 02841
Actively Recruiting
Research Team
S
Sari Ahlqvist-Björkroth
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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