Clinical trial NCT05230199: Sensory Optimization of the Hospital Environment
Official title: Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm
Parent-Child Relations
Parents
Development, Infant
Sensory Integration Dysfunction
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: St. Louis University
name: Washington University School of Medicine
name: University of North Carolina
name: Harvard University
name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: St. Louis Children's Hospital
First posted: 2022-02-08
Enrollment: 215
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \> 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.

Primary outcomes:
measure: Bayley Scales of Infant Toddler Development, 4th Edition
timeFrame: 2 years adjusted age
Secondary outcomes:
measure: Bayley Scales of Infant Toddler Development, 4th Edition
timeFrame: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
measure: NICU Network Neurobehavioral Assessment Scale
timeFrame: Between 35-41 weeks PMA
measure: Sensory Profile 2
timeFrame: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
measure: Modified Checklist for Autism in Toddlers
timeFrame: 2 years adjusted age
measure: Ages and Stages Questionnaire-3
timeFrame: 6 months adjusted age, 1 and 2 years adjusted age
measure: Child Behavior Checklist (CBCL)
timeFrame: 2 years adjusted
measure: Emotional Availability Scales
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
measure: State Trait Anxiety Inventory
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
measure: Life Stress Subscale of the Parenting Stress Index (PSI)
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: aEEG Burdjalov Score
timeFrame: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
Other outcomes:
measure: Home Observation Measurement of the Environment
timeFrame: At 6 months, one and two years adjusted age
measure: Family Resilience Assessment Scale
timeFrame: At 6 months, one and two years adjusted age
measure: Experiences and Satisfaction During Preterm Birth
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Parent Stress Scale
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Parent Stress Scale: NICU
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Maternal Confidence Questionnaire
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Infant Care Questionnaire
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Parent Stress Inventory
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age
measure: Parenting Sense of Competence
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age, 1 year adjusted age, 2 years adjusted age
measure: Neonatal Eating Outcome Assessment Tool
timeFrame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)
measure: Post Traumatic Stress Disorder Questionnaire
timeFrame: 6 months adjusted age, 1 year adjusted age
measure: Sleep and Settle Questionnaire
timeFrame: 6 months adjusted age, 1 year adjusted age
measure: General Anxiety Disorder 7 Scale
timeFrame: 6 months adjusted age
measure: Beck Depression Inventory II
timeFrame: 6 months adjusted age, 1 year adjusted age, 2 years adjusted age
measure: Pediatric Eating Assessment Tool
timeFrame: 1 year adjusted age, 2 years adjusted age
measure: Behavioral Pediatric Feeding Assessment Scale
timeFrame: 1 year adjusted age, 2 years adjusted age
measure: NEO-Eat
timeFrame: 6 months adjusted age
Locations:
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
Study officials:
affiliation: University of Southern California
name: Roberta Pineda, PhD OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Amit Mathur, MD
role: PRINCIPAL_INVESTIGATOR
References: