Sensory Optimization of the Hospital Environment

Parent-Child Relations Clinical Trial

— SOOTHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230199
• Other study ID #: R01HD105557
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: March 2027

Study information

• Verified date: July 2023
• Source: University of Southern California
• Contact: Roberta Pineda, PhD OTR/L
• Phone: (323) 442-2850
• Email: bobbi.pineda[@]chan.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: March 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Development, Infant
• Parent-Child Relations
• Parents
• Premature Birth
• Preterm
• Sensory Integration Dysfunction

Intervention

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.
• Monitored standard of care
Infants who receive sensory exposures only as standard of care but do not recieve the SENSE program

Locations

Country	Name	City	State
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri

Sponsors (7)

Lead Sponsor	Collaborator
University of Southern California	Harvard University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., St. Louis Children's Hospital, St. Louis University, University of North Carolina, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home Observation Measurement of the Environment	self report measure of the home environment	At 6 months, one and two years adjusted age
Other	Family Resilience Assessment Scale	self report measure of family resilience	At 6 months, one and two years adjusted age
Primary	Bayley Scales of Infant Toddler Development, 4th Edition, language outcome	Standardized assessment of language; The highest possible score on the language domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average.	2 years adjusted age is primary outcome; also will be done at 1 year adjusted
Secondary	Bayley Scales of Infant Toddler Development, 4th Edition, motor outcome	Standardized assessment of motor; The highest possible score on the motor domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average.	1 and 2 years adjusted age
Secondary	Bayley Scales of Infant Toddler Development, 4th Edition, cognitive outcome	Standardized assessment of cognition: The highest possible score on the cognitive domain is 19 and the lowest possible score is 1. Scores from 8-12 are considered average.	1 and 2 years adjusted age
Secondary	NICU Network Neurobehavioral Assessment Scale	Standardized neonatal neurobehavioral assessment	Between 35-41 weeks PMA
Secondary	Sensory Profile 2	Parent-report measure of sensory processing	Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,
Secondary	Modified Checklist for Autism in Toddlers	Parent report measure of sensory features	2 years adjusted age
Secondary	Ages and Stages Questionnaire-3	parent report measure of development	6 months adjusted age.
Secondary	Child Behavior Checklist (CBCL)	Parent report measure of social emotional function	2 years adjusted
Secondary	Parent Child Early Relational Assessment (PCERA)	Standardized observational assessment of parent-child interaction	2 years adjusted
Secondary	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
Secondary	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
Secondary	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) and at 6 months, one and 2 years adjusted age
Secondary	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