Sensory Optimization of the Hospital Environment

Официальное название

Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit

Обзор

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

Подробное описание

Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU (and associated Level III NICU) will be enrolled within 1 week of birth. Infants will be randomized to either the SENSE multisensory program or to the standard of care during the NICU stay. The SENSE program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the NICU. Standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to NICU discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. Differences between groups will be investigated. Brain activity during NICU stay, including in the presence and absence of different sensory exposures, will also be investigated. The expected outcome is that the SENSE multisensory program will have a positive effect on improving outcomes.

Вмешательства

• Поведенческое SENSE multisensory program
  In order to support parent's ability to implement the daily SENSE program they will be provided with an educational manual reviewing the program, weekly meetings with a therapist, and logs to report their visitation schedule and activities. Parents are able to choose different types of each sensory exposure. All options address the same key principles for that behavior and only include those that have evidence to support their use and are appropriate at each PMA.
• Поведенческое Monitored standard of care
  Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program

Первичные конечные точки

• Bayley Scales of Infant Toddler Development, 4th Edition [Срок оценки: 2 years adjusted age]

Вторичные конечные точки (11)

• Bayley Scales of Infant Toddler Development, 4th Edition [Срок оценки: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)]
• NICU Network Neurobehavioral Assessment Scale [Срок оценки: Between 35-41 weeks PMA]
• Sensory Profile 2 [Срок оценки: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,]
• Modified Checklist for Autism in Toddlers [Срок оценки: 2 years adjusted age]
• Ages and Stages Questionnaire-3 [Срок оценки: 6 months adjusted age, 1 and 2 years adjusted age]
• Child Behavior Checklist (CBCL) [Срок оценки: 2 years adjusted]
• Emotional Availability Scales [Срок оценки: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted]
• State Trait Anxiety Inventory [Срок оценки: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age]
• Life Stress Subscale of the Parenting Stress Index (PSI) [Срок оценки: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age]
• Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: Prior to the infant's discharge from the NICU (35-41 weeks PMA)]
• aEEG Burdjalov Score [Срок оценки: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours]

Критерии участия

Критерии включения

• ≤ 32 weeks estimated gestational age (EGA)
• recruited within the first week of life

Критерии исключения

• > 32 weeks EGA at birth
• >7 days old
• become wards of the state
• have a suspected or confirmed congenital anomaly
• face a high immediate threat of death, per the opinion of the attending physician.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cardinal Glennon Children's Hospital — St Louis

Идентификаторы

NCT: NCT05230199 · R01HD105557

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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