Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT05230199

Conditions

Preterm

Parent-Child Relations

Parents

Development, Infant

Sensory Integration Dysfunction

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

SENSE multisensory program

Monitored standard of care

Study Details

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

Study ID

NCT05230199

Start date

May 29, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Monitored standard of care

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

Primary outcome measure

  • Bayley Scales of Infant Toddler Development, 4th Edition [ Time Frame: 2 years adjusted age ]

Central Contacts and Locations

Central contacts

Roberta Pineda, PhD OTR/L

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

Amit Mathur, MD

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

Locations

Cardinal Glennon Children's Hospital

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Amit Mathur, MD, PhD

(314) 577-5360amit.mathur@health.slu.edu

More Information

Sponsor

University of Southern California

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-17.