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Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 7 days
Healthy Volunteers: f
View:

• preterm infants born below 32 weeks of gestation and/or weighing \< 1500 g who receive long-term follow-up at each study site.

Locations
Other Locations
Japan
Kyoto University Hospital
NOT_YET_RECRUITING
Kyoto
Nagano Children's Hospital
NOT_YET_RECRUITING
Matsumoto
Republic of Korea
Korea University Anam Hospital NICU
RECRUITING
Seoul
Contact Information
Primary
Sari Ahlqvist-Björkroth
sarahl@utu.fi
358-40-511-9600
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
No_intervention: Pre-intervention
Prior to the implementation of the Close Collaboration with Parents (CCP) training program, staff provide routine care according to standard NICU practices.
Experimental: Post-intervention
After the implementation of the CCP training program, all NICU staff participate in the intervention, applying the learned practices to include parents in the care of their infants in the NICU.
Related Therapeutic Areas
Sponsors
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov