Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
Recruiting now · Not applicable
Conditions studied: Preterm Infant Development, Preterm Infant Health
In brief
Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.
Key facts
- Study ID
- NCT07306000
- Run by
- Turku University Hospital
- People needed
- 100
- Starts
- 2025-12-22
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2025-12-31
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
You may not qualify if…
- the infant has any major anomalies
- the infants are triplets or higher order
- the infant's condition is critical and the survival is uncertain
- the parents cannot understand the informed consent form in Korean or in Japanese
Where it is running
- Korea University Anam Hospital NICU — Seoul, South Korea (enrolling)
- Nagano Children's Hospital — Matsumoto, Nagano, Japan
- Kyoto University Hospital — Kyoto, Japan
Full record on ClinicalTrials.gov
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