Sensory Optimization of the Hospital Environment

NCT05230199 | Recruiting DMC

• 1 other identifier: R01HD105557
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Parent-Child Relations; Parents; Development, Infant; Sensory Integration Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Bayley Scales of Infant Toddler Development, 4th Edition

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

• NICU Network Neurobehavioral Assessment Scale

  Between 35-41 weeks PMA

• Sensory Profile 2

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

• Modified Checklist for Autism in Toddlers

  2 years adjusted age

• Ages and Stages Questionnaire-3

  6 months adjusted age, 1 and 2 years adjusted age

Other Outcomes (17)

• Home Observation Measurement of the Environment

  At 6 months, one and two years adjusted age

• Family Resilience Assessment Scale

  At 6 months, one and two years adjusted age

• Experiences and Satisfaction During Preterm Birth

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

Study Arms (2)

Monitored standard of care

ACTIVE COMPARATOR

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

SENSE multisensory program

EXPERIMENTAL

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

Interventions

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.

SENSE multisensory program

Monitored standard of care BEHAVIORAL

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

Monitored standard of care

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• University of Southern California: lead
• St. Louis University: collaborator
• Washington University School of Medicine: collaborator
• University of North Carolina: collaborator
• Harvard University: collaborator
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator
• St. Louis Children's Hospital: collaborator

Study Sites (1)

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roberta Pineda, PhD OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Amit Mathur, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Pineda, PhD OTR/L

CONTACT

(323) 442-2850; bobbi.pineda@chan.usc.edu

Amit Mathur, MD

CONTACT

314) 577-5642; amit.mathur@health.slu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Parents will enroll in this study, understanding that they will be assigned to one of two types of sensory approaches. They will be masked from whether they are in the treatment (SENSE group) or control group (standard of care). After enrollment, the SENSE program will be described to those parents assigned to the SENSE group. The use of nurses and therapists to aid the parent in conducting sensory interventions at the bedside will be described to those parents assigned to the standard of care group. All assessments in the NICU will be conducted at the infant's bedside by a certified (when necessary) and trained evaluator who is blinded to treatment assignment. All assessments following NICU discharge will be conducted by a different blinded evaluator (to decrease bias), who is trained and experienced with standardized childhood assessment. The evaluators will not be involved in other study-related activities in order to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: May 29, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)