Sensory Optimization of the Hospital Environment

NCT ID: NCT05230199

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2027-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Monitored standard of care

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

SENSE multisensory program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Monitored standard of care

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role: collaborator

St. Louis Children's Hospital

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Roberta Pineda

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta Pineda, PhD OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Amit Mathur, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roberta Pineda, PhD OTR/L

Role: CONTACT

bobbi.pineda@chan.usc.edu

(323) 442-2850

Amit Mathur, MD

Role: CONTACT

amit.mathur@health.slu.edu

314) 577-5642

Facility Contacts

Amit Mathur, MD, PhD

Role: primary

amit.mathur@health.slu.edu

314-577-5360

Other Identifiers

R01HD105557

Identifier Type: NIH

Identifier Source: org_study_id

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