Close Collaboration with Parents training to strengthen parent–staff partnership in the NICU
Official title: Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study
Run by Turku University Hospital · NCT07306000 · Data updated 2026-11-12
This pilot tests whether training NICU staff to work closely with parents improves long-term development and parent–infant interaction for very preterm infants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Hour to 7 Days |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Turku University Hospital Government |
| Locations | 3 sites (Matsumoto, Nagano and 2 other locations) |
| Status | Recruiting |
| Started | December 22, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT07306000 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are very preterm infants (born before 32 weeks gestation and/or weighing under 1500 g) receiving long-term follow-up at one of the participating NICUs whose parents can consent in Korean or Japanese and whose clinical condition is stable.
✕Probably not a fit
Infants with major congenital anomalies, triplets or higher-order multiples, those with critical unstable conditions, or families unable to consent in the study languages are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot will train multi-professional NICU staff in the Close Collaboration with Parents (CCP) program and use the intervention to refine and validate measurement tools before a larger cluster randomized trial. It is a multicenter feasibility study conducted at participating NICUs in Japan and South Korea enrolling infants born before 32 weeks gestation and/or weighing under 1500 g who attend long-term follow-up. The study will examine feasibility of instruments that measure neurodevelopment, socio-emotional development, and parent–infant interaction and will collect data needed to calculate sample size for the definitive trial. Infants with major anomalies, higher-order multiples, or unstable survival prognoses are excluded, and parents must understand consent in Korean or Japanese.
Why it matters
Potential benefit: If successful, the intervention could increase parental participation in care and lead to better long-term neurodevelopmental and socio-emotional outcomes for very preterm infants.
How similar studies have gone: CCP is an evidence-based staff education approach that has improved parental involvement and short-term NICU processes in previous work, but its effects on long-term neurodevelopmental and socio-emotional outcomes in very preterm infants have not yet been tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Korea University Anam Hospital NICU
Seoul, South Korea Recruiting -
Nagano Children's Hospital
Matsumoto, Nagano, Japan Not yet recruiting -
Kyoto University Hospital
Kyoto, Japan Not yet recruiting
Study contacts
- Study coordinator: Sari Ahlqvist-Björkroth
- Email: sarahl@utu.fi
- Phone: 358-40-511-9600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.