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

NCT07306000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-31

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Hour
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306000 on ClinicalTrials.gov