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Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development

RecruitingNAAges 1 Hour - 7 DaysAllTurku University Hospital
NCT07306000 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * preterm infants born below 32 weeks of gestation and/or weighing \< 1500 g who receive long-term follow-up at each study site. Exclusion Criteria: * 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
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What it tests

  • Close Collaboration with Parents training
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Where

3 sites
Nagano Children's Hospital
Matsumoto, Japan
Kyoto University Hospital
Kyoto, Japan
Korea University Anam Hospital NICU
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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