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Recruiting NCT07306000

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

No phase Interventional Preterm Infant Development Preterm Infant Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Close Collaboration with Parents training.
Who it may be relevant to
Registry conditions: Preterm Infant Development, Preterm Infant Health. Basic parameters: 1 Hour — 7 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study

Overview

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.

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 pra

Primary outcome measures

  • Auditory environment: parent and adult speech [Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
  • Auditory environment: sound level and its variation [Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
  • Sensitive care: sleep quality and quantity [Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
  • Parents' presence and parent-infant skin-to-skin contact [Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
  • Type of enteral feeding [Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
  • Body weight [Time frame: every 7 days, from enrollment to the NICU discharge (up to 40 weeks of postmenstrual age), 1 month of corrected age, 6 months of corrected age, 18 months of corrected age, and 36 months]
Secondary outcome measures (10)
  • Breastfeeding [Time frame: between 36+0 and 36+6 weeks of postmenstrual age (7 days), and between 7 and 1 day before the day of NICU discharge (7 days)]
  • Parents' parenting self-efficacy [Time frame: at 36 weeks of postmenstrual age, at the day of NICU discharge (up to 40 weeks of postmenstrual age), and 1 month of corrected age]
  • Length of stay and PMA at discharge [Time frame: at the day of NICU discharge (up to 40 weeks of postmenstrual age)]
  • Brain MRI [Time frame: at the term age, between 37+0 and 41+6 weeks of postmenstrual age]
  • Parent-infant interaction: eye movement and behavior tracking [Time frame: at 6 months of corrected age, for 10 minutes]
  • Cry diary [Time frame: at 6 months of corrected age, for 3 days]
  • Infant Behavior Questionnaire-Revised (IBQ-R) [Time frame: at 6 months of corrected age]
  • Early Childhood Behavior Questionnaire (ECBQ) [Time frame: at 18 months of corrected age]
  • Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) [Time frame: at 18 months of corrected age and 3 years of age]
  • Infant Toddler Social Emotional Assessment (ITSEA) [Time frame: at 18 months of corrected age and 3 years of age]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Supportive care

Study locations

Japan · 2 centers
  • Nagano Children's Hospital — Matsumoto
  • Kyoto University Hospital — Kyoto
South Korea · 1 center
  • Korea University Anam Hospital NICU — Seoul

Identifiers

NCT: NCT07306000 · PilotStudy/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗