Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorTurku University Hospital
About this trial
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 criteria
Qualifiers
preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
Disqualifiers
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
Treatments tested in this trial
- Close Collaboration with Parents training
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov