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

NCT ID: NCT07306000

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-28
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Preterm Infant Development; Preterm Infant Health

Keywords

close collaboration with parents; family-centered care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pre-intervention

Prior to the implementation of the Close Collaboration with Parents (CCP) training program, staff provide routine care according to standard NICU practices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Close Collaboration with Parents training

Intervention Type: BEHAVIORAL

The Close Collaboration with Parents is an educational intervention for neonatal health care staff. The "train the trainer" model is used in the implementation so that the training team trains local mentors in each NICU, who then mentor the other neonatal health care staff. Local mentors are chosen from the neonatal health care team (nurses, doctors, or psychologists) working in the NICU. The learning process of neonatal health care teams includes completing the e-learning module and bedside practices combined with reflection on the practice experience with a local mentor. The final goal is to improve the family-centered care culture of the NICU by developing the skills of the neonatal health care team to communicate and collaborate with parents and to provide support for parenting.

Interventions

Close Collaboration with Parents training

The Close Collaboration with Parents is an educational intervention for neonatal health care staff. The "train the trainer" model is used in the implementation so that the training team trains local mentors in each NICU, who then mentor the other neonatal health care staff. Local mentors are chosen from the neonatal health care team (nurses, doctors, or psychologists) working in the NICU. The learning process of neonatal health care teams includes completing the e-learning module and bedside practices combined with reflection on the practice experience with a local mentor. The final goal is to improve the family-centered care culture of the NICU by developing the skills of the neonatal health care team to communicate and collaborate with parents and to provide support for parenting.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Liisa Lehtonen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nagano Children's Hospital

Matsumoto, Nagano, Japan

Kyoto University Hospital

Kyoto, , Japan

Korea University Anam Hospital NICU

Seoul, , South Korea

Countries

Japan; South Korea

Central Contacts

Sari Ahlqvist-Björkroth

Role: CONTACT

Phone: 358-40-511-9600

Email: sarahl@utu.fi

Facility Contacts

Ryo Itoshima

Role: primary

Seiichi Tomotaki

Role: primary

Juyoung Lee, Professor

Role: primary

Other Identifiers

PilotStudy/2025

Identifier Type: -

Identifier Source: org_study_id