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NCT Number: NCT05230199

Sensory Optimization of the Hospital Environment

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.

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Key information

Conditions

Preterm Development, Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Parent-Child Relations Parents Pregnancy Complications Premature Birth Sensory Integration Dysfunction Urogenital Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location status: Recruiting

Location contact

Amit Mathur, MD, PhD

CONTACT

[email protected]

(314) 577-5360

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SENSE multisensory program

Behavioral

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

Behavioral

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

Primary outcomes

  1. Bayley Scales of Infant Toddler Development, 4th Edition

    Time frame: 2 years adjusted age

    Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome

Secondary outcomes

  1. Bayley Scales of Infant Toddler Development, 4th Edition

    Time frame: 6 months and 1 year adjusted age (when completed in newborn follow-up clinic)

    Standardized assessment of language, cognitive, and motor

  2. NICU Network Neurobehavioral Assessment Scale

    Time frame: Between 35-41 weeks PMA

    Standardized neonatal neurobehavioral assessment

  3. Sensory Profile 2

    Time frame: Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,

    Parent-report measure of sensory processing

  4. Modified Checklist for Autism in Toddlers

    Time frame: 2 years adjusted age

    Parent report measure of sensory features

  5. Ages and Stages Questionnaire-3

    Time frame: 6 months adjusted age, 1 and 2 years adjusted age

    parent report measure of development

  6. Child Behavior Checklist (CBCL)

    Time frame: 2 years adjusted

    Parent report measure of social emotional function

  7. Emotional Availability Scales

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted

    Standardized observational assessment of parent-child interaction

  8. State Trait Anxiety Inventory

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age

    Self report measure of anxiety

  9. Life Stress Subscale of the Parenting Stress Index (PSI)

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age

    Self report measure of stress

  10. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    Self report measure of maternal postpartum depression

  11. aEEG Burdjalov Score

    Time frame: within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours

    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

Other outcomes

  1. Home Observation Measurement of the Environment

    Time frame: At 6 months, one and two years adjusted age

    self report measure of the home environment

  2. Family Resilience Assessment Scale

    Time frame: At 6 months, one and two years adjusted age

    self report measure of family resilience

  3. Experiences and Satisfaction During Preterm Birth

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    self report measure of parent experience in NICU

  4. Parent Stress Scale

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    self report measure of parent stress

  5. Parent Stress Scale: NICU

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    Self report measure of parent stress related to NICU hospitalization

  6. Maternal Confidence Questionnaire

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    Self report measure of parental confidence related to care of infant

  7. Infant Care Questionnaire

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    Self report measure of parental confidence related to care of infant

  8. Parent Stress Inventory

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA), 6 months adjusted age

    Self report measure of parent stress

  9. Parenting Sense of Competence

    Time frame: 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

    Self report measure of parent feelings of competence related to care of infant

  10. Neonatal Eating Outcome Assessment Tool

    Time frame: Prior to the infant's discharge from the NICU (35-41 weeks PMA)

    Assessment of infant feeding skills

  11. Post Traumatic Stress Disorder Questionnaire

    Time frame: 6 months adjusted age, 1 year adjusted age

    Assessment of parental PTSD

  12. Sleep and Settle Questionnaire

    Time frame: 6 months adjusted age, 1 year adjusted age

    Assessment of infant sleep patterns

  13. General Anxiety Disorder 7 Scale

    Time frame: 6 months adjusted age

    Assessment of parental anxiety

  14. Beck Depression Inventory II

    Time frame: 6 months adjusted age, 1 year adjusted age, 2 years adjusted age

    Assessment of parental depression

  15. Pediatric Eating Assessment Tool

    Time frame: 1 year adjusted age, 2 years adjusted age

    Assessment of child feeding skills

  16. Behavioral Pediatric Feeding Assessment Scale

    Time frame: 1 year adjusted age, 2 years adjusted age

    Assessment of child feeding behaviors

  17. NEO-Eat

    Time frame: 6 months adjusted age

    Parent report measure of feeding during infancy

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Mathur, MD

CONTACT

[email protected]

314) 577-5642

Roberta Pineda, PhD OTR/L

CONTACT

[email protected]

(323) 442-2850

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: SOOTHE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 8, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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