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

Turku University Hospital (TYKS)

Status: Enrolling

Conditions: Preterm Infant Health; Preterm Infant Development

Treatments: Behavioral: Close Collaboration with Parents training

Study type: Interventional

Funder types: Other

Identifiers

NCT07306000

PilotStudy/2025

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 hour to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pre-intervention

No Intervention group

Description:

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

Post-intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Close Collaboration with Parents training