What is the mechanism of action of this treatment?

The most common treatments for preterm birth, such as those studied in the SENSE trial, include massage, auditory exposure, rocking, holding, and skin-to-skin care. These interventions replicate the natural sensory experiences of the womb, crucial for neurological and developmental growth. Massage stimulates the nervous system and improves circulation, promoting growth and relaxation. Auditory exposure enhances auditory processing and bonding. Rocking and holding provide vestibular stimulation, important for balance and spatial orientation. Skin-to-skin care regulates the infant's temperature, heart rate, and breathing, while also promoting bonding and breastfeeding. These treatments collectively foster healthy development and strengthen the parent-child relationship, essential for preterm infants at higher risk for developmental delays and health complications.

What side effects are associated with this type of intervention?

The treatments studied in the SENSE trial, including massage, auditory exposure, rocking, holding, and skin-to-skin care, are generally considered safe and beneficial for preterm infants. These interventions aim to improve developmental outcomes and parent-child interaction. Known side effects are minimal but may include overstimulation or discomfort if not properly timed or adapted to the infant's medical status and behavioral cues. Proper education and support for parents are crucial to minimize any potential adverse effects.

What prior FDA approvals exist?

The SENSE trial focuses on structured multisensory interventions like massage, auditory exposure, rocking, holding, and skin-to-skin care to improve developmental outcomes and parent-child interaction in preterm infants. While the provided context does not mention specific FDA approvals or related drugs for these types of interventions, it highlights the importance of non-pharmacological approaches in neonatal care. These interventions are designed to support the developmental needs of preterm infants and enhance parent-infant bonding, which are critical for long-term health and well-being.

What other types of research exist?

Promising novel alternatives to SENSE for preterm birth patients include: 1) Music therapy, which has been shown to reduce anxiety and improve developmental outcomes; 2) Acupuncture, which may offer benefits for pain management and overall well-being; 3) Reflexology, which has shown potential in improving sensory function and reducing pain; 4) Mindfulness-based practices for parents, which can enhance parent mental health and parent-child interaction. These therapies can be considered as adjuncts or alternatives to the SENSE program.

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Multisensory Intervention for Premature Birth (SOOTHE Trial)

N/A

Recruiting

Led By Amit Mathur, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recruited within the first week of life

≤ 32 weeks estimated gestational age (EGA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to the infant's discharge from the nicu (35-41 weeks pma) and at 2 years adjusted

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help preterm babies and their parents by using a structured program called SENSE. The program includes activities like massage and skin-to-skin contact that parents can do regularly. These activities are designed to support the baby's development and improve parent-child bonding. The SENSE program is a structured sensory-based program developed to maximize the benefit of parent-directed, positive sensory exposures in the NICU.

Who is the study for?

This trial is for infants born prematurely (≤32 weeks gestational age) and within their first week of life. It's not suitable for those older than 7 days, with a high risk of immediate death, wards of the state, or suspected congenital anomalies.

What is being tested?

The study tests a structured multisensory program called SENSE against standard care in the NICU. SENSE includes massage, auditory exposure, rocking, holding, and skin-to-skin care tailored to each infant's developmental stage and health status.

What are the potential side effects?

As this intervention involves non-invasive sensory activities provided by parents under guidance in the NICU setting, no direct side effects are anticipated; however individual responses may vary based on each infant’s condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is less than one week old.

Select...

I am less than or equal to 32 weeks pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to the infant's discharge from the nicu (35-41 weeks pma) and at 2 years adjusted

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to the infant's discharge from the nicu (35-41 weeks pma) and at 2 years adjusted

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to the infant's discharge from the nicu (35-41 weeks pma) and at 2 years adjusted for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Ages and Stages Questionnaire-3

Bayley Scales of Infant Toddler Development, 4th Edition

Child Behavior Checklist (CBCL)

+8 more

Other study objectives

Beck Depression Inventory II

Behavioral Pediatric Feeding Assessment Scale

Experiences and Satisfaction During Preterm Birth

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SENSE multisensory programExperimental Treatment1 Intervention

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 II: Monitored standard of careActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for preterm birth, such as those studied in the SENSE trial, include massage, auditory exposure, rocking, holding, and skin-to-skin care. These interventions replicate the natural sensory experiences of the womb, crucial for neurological and developmental growth. Massage stimulates the nervous system and improves circulation, promoting growth and relaxation. Auditory exposure enhances auditory processing and bonding. Rocking and holding provide vestibular stimulation, important for balance and spatial orientation. Skin-to-skin care regulates the infant's temperature, heart rate, and breathing, while also promoting bonding and breastfeeding. These treatments collectively foster healthy development and strengthen the parent-child relationship, essential for preterm infants at higher risk for developmental delays and health complications.