Actively Recruiting

Phase Not Applicable
Age: 1Hour - 7Days
All Genders
NCT07306000

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

Led by Turku University Hospital · Updated on 2025-12-31

100

Participants Needed

3

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Hour - 7Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born below 32 weeks of gestation and/or weighing less than 1500 grams
  • Infants receiving long-term follow-up at each study site
Not Eligible

You will not qualify if you...

  • Infant has any major anomalies
  • Infants are triplets or higher order multiples
  • Infant's condition is critical with uncertain survival
  • Parents cannot understand the informed consent form in Korean or Japanese

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Nagano Children's Hospital

Matsumoto, Nagano, Japan

Not Yet Recruiting

2

Kyoto University Hospital

Kyoto, Japan

Not Yet Recruiting

3

Korea University Anam Hospital NICU

Seoul, South Korea, 02841

Actively Recruiting

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Research Team

S

Sari Ahlqvist-Björkroth

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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