Sensory Optimization of the Hospital Environment (SOOTHE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parent-Child Relations; Parents; Development, Infant; Preterm; Sensory Integration Dysfunction
• Intervention / Treatment: Behavioral: Monitored standard of care; Behavioral: SENSE multisensory program

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.

• Study Type: Interventional
• Enrollment (Estimated): 215
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Pineda, PhD OTR/L; Phone Number: (323) 442-2850; Email: bobbi.pineda@chan.usc.edu
• Study Contact Backup: Name: Amit Mathur, MD; Phone Number: 314) 577-5642; Email: amit.mathur@health.slu.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Recruiting
      • Cardinal Glennon Children's Hospital
      • Contact: Amit Mathur, MD, PhD; Phone Number: 314-577-5360; Email: amit.mathur@health.slu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monitored standard of care; At the study site, much like other contemporary NICUs, parents are encouraged to be present 24 hours per day, with significant variability in the amount, types and timing of parent engagement. Infant holding is supported, provided the infant can maintain physiological stability during handling. Parents can hold infants on mechanical ventilation, but holding is not encouraged during times when the infant is on oscillatory ventilation and/or when chest tubes are in place. Holding time may be restricted in infants <32 weeks due to temperature instability. Nurses and therapists foster parent participation through instruction on caregiving and developmentally appropriate interactions, but these are balanced with other priorities of care. With standard of care, there is no targeted and set amount of positive sensory exposure, and practices vary based on the comfort level of nurses, the medical team, and the parents.	Behavioral: Monitored standard of care; Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program
Experimental: SENSE multisensory program; The SENSE program includes the provision of specific types and amounts of evidence-based tactile, auditory, visual, vestibular/kinesthetic, and olfactory interventions to be conducted by parents with their preterm infants, with a specific amount defined for each day of hospitalization. The program changes across PMA and an infant's tolerance of the prescribed activities. A sensory support team can fill in the gaps in intervention for infants in the SENSE group when parents are not available. The parent education materials identify specific doses of sensory inputs at each PMA. Feasibility has been established, with provision of an average of 155 hours of sensory exposures across NICU hospitalization.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant Toddler Development, 4th Edition	Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome	2 years adjusted age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NICU Network Neurobehavioral Assessment Scale	Standardized neonatal neurobehavioral assessment	Between 35-41 weeks PMA
Sensory Profile 2	Parent-report measure of sensory processing	Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Modified Checklist for Autism in Toddlers	Parent report measure of sensory features	2 years adjusted age
Child Behavior Checklist (CBCL)	Parent report measure of social emotional function	2 years adjusted
State Trait Anxiety Inventory	Self report measure of anxiety	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)	Self report measure of stress	Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age
aEEG Burdjalov Score	The Olympic Brainz Monitor (OBM) Monitor (TMNatus), which provides continuous cerebral function monitoring, will be used for aEEG recordings at four time points. After a minimum baseline aEEG tracing of 4 hours, a sensory intervention (that has no movement artifact) will be performed for one hour, followed by monitoring for one additional hour after the sensory intervention is removed. This will be a total monitoring time of 6 hours. We will record who performed the intervention (parent, volunteer, research member) and the type of intervention (ie. holding, kangaroo, reading). Scores will also be evaluated as an outcome measure across PMA	within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours
Bayley Scales of Infant Toddler Development, 4th Edition	Standardized assessment of language, cognitive, and motor	6 months and 1 year adjusted age (when completed in newborn follow-up clinic)
Ages and Stages Questionnaire-3	parent report measure of development	6 months adjusted age, 1 and 2 years adjusted age
Emotional Availability Scales	Standardized observational assessment of parent-child interaction	Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted
Edinburgh Postnatal Depression Scale (EPDS)	Self report measure of maternal postpartum depression	Prior to the infant's discharge from the NICU (35-41 weeks PMA)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Observation Measurement of the Environment	self report measure of the home environment	At 6 months, one and two years adjusted age
Family Resilience Assessment Scale	self report measure of family resilience	At 6 months, one and two years adjusted age
Experiences and Satisfaction During Preterm Birth	self report measure of parent experience in NICU	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Scale	self report measure of parent stress	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Scale: NICU	Self report measure of parent stress related to NICU hospitalization	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Maternal Confidence Questionnaire	Self report measure of parental confidence related to care of infant	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Infant Care Questionnaire	Self report measure of parental confidence related to care of infant	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Parent Stress Inventory	Self report measure of parent stress	Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age
Parenting Sense of Competence	Self report measure of parent feelings of competence related to care of infant	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
Neonatal Eating Outcome Assessment Tool	Assessment of infant feeding skills	Prior to the infant's discharge from the NICU (35-41 weeks PMA)
Post Traumatic Stress Disorder Questionnaire	Assessment of parental PTSD	6 months adjusted age, 1 year adjusted age
Sleep and Settle Questionnaire	Assessment of infant sleep patterns	6 months adjusted age, 1 year adjusted age
General Anxiety Disorder 7 Scale	Assessment of parental anxiety	6 months adjusted age
Beck Depression Inventory II	Assessment of parental depression	6 months adjusted age, 1 year adjusted age, 2 years adjusted age
Pediatric Eating Assessment Tool	Assessment of child feeding skills	1 year adjusted age, 2 years adjusted age
Behavioral Pediatric Feeding Assessment Scale	Assessment of child feeding behaviors	1 year adjusted age, 2 years adjusted age
NEO-Eat	Parent report measure of feeding during infancy	6 months adjusted age

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Washington University School of Medicine; Harvard University; St. Louis Children's Hospital; Hugo W. Moser Research Institute at Kennedy Krieger, Inc.; St. Louis University; University of North Carolina
• Investigators: Principal Investigator: Roberta Pineda, PhD OTR/L, University of Southern California; Principal Investigator: Amit Mathur, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: R01HD105557 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No