Идёт набор NCT07306000

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

Без фазы С лечением Preterm Infant Development Preterm Infant Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Close Collaboration with Parents training.
Кому может быть актуально: Состояния в реестре: Preterm Infant Development, Preterm Infant Health. Базовые параметры: 1 Hour — 7 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Япония, South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Поведенческое 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

Первичные конечные точки

Auditory environment: parent and adult speech [Срок оценки: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
Auditory environment: sound level and its variation [Срок оценки: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
Sensitive care: sleep quality and quantity [Срок оценки: 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 [Срок оценки: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
Type of enteral feeding [Срок оценки: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)]
Body weight [Срок оценки: 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]

Вторичные конечные точки (10)

Breastfeeding [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: at the day of NICU discharge (up to 40 weeks of postmenstrual age)]
Brain MRI [Срок оценки: at the term age, between 37+0 and 41+6 weeks of postmenstrual age]
Parent-infant interaction: eye movement and behavior tracking [Срок оценки: at 6 months of corrected age, for 10 minutes]
Cry diary [Срок оценки: at 6 months of corrected age, for 3 days]
Infant Behavior Questionnaire-Revised (IBQ-R) [Срок оценки: at 6 months of corrected age]
Early Childhood Behavior Questionnaire (ECBQ) [Срок оценки: at 18 months of corrected age]
Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) [Срок оценки: at 18 months of corrected age and 3 years of age]
Infant Toddler Social Emotional Assessment (ITSEA) [Срок оценки: at 18 months of corrected age and 3 years of age]

Критерии участия

Критерии включения

preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет