← Back to Search

Multisensory Intervention for Prematurity

N/A
Waitlist Available
Led By Nathalie L Maitre, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Family history of genetic hearing loss
Use of sedatives or seizure medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years (22-26 months corrected age)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment for preterm babies that uses their mother's voice, touch, and scent to help their brain develop better. The treatment is aimed at babies born early who often have trouble with brain development. By giving these babies familiar and comforting sensory experiences, the treatment hopes to improve their long-term growth and abilities.

Who is the study for?
This trial is for preterm infants hospitalized at a study location, with a postmenstrual age between 32 and 36 weeks. It's not for babies with genetic hearing loss, those on sedatives or seizure meds, using endotracheal tubes for breathing, or with major birth defects.
What is being tested?
The trial tests an intervention to help premature babies' brains develop better by using multisensory experiences like skin-to-skin care from parents or therapists and exposure to the parent's voice (live or recorded), aiming to improve sensory processing and long-term language and motor skills.
What are the potential side effects?
Since this intervention involves non-invasive methods such as skin-to-skin contact and auditory stimulation through parental voices, there are minimal expected side effects. However, individual responses may vary based on each infant's condition.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My family has a history of genetic hearing loss.
Select...
I am currently taking sedatives or medications for seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years (22-26 months corrected age)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (22-26 months corrected age) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Index of Multisensory Processing (IMP)
Secondary study objectives
Change in Bayley Scales of Infant and Toddler Development - 3rd Edition (Bayley III) Score
Change in Preschool Language Scales - 5th Edition (PLS-5) Score
Infant/Toddler Sensory Profile (ITSP) Score
Other study objectives
Secondary Study: Contingent speech sound learning in infants
WECS

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
Group I: Standard of CareExperimental Treatment2 Interventions
Preterm infants in the NICU who are randomized to receive the standard of care. The standard care for preterm infants in the NICU currently follows medical protocols of skin-to-skin holding and exposure to recordings of parent's voice.
Group II: Multisensory InterventionExperimental Treatment4 Interventions
Preterm infants in the NICU who are randomized to receive a multisensory intervention, in addition to the standard of care. The multisensory intervention uses recordings of the parents' voices and nurturing touch administered in the NICU during 12 to 23 sessions of standardized, therapist-administered, auditory-tactile stimulation, dispersed over a 2 to 3 week period. The intervention includes 2 components: (1) holding and light pressure containment of the infant against the hospital-gown covered chest of the therapist for tactile and non-specific auditory stimulation simultaneous with (2) playing of mother's voice contingent on infant pacifier sucking. Additionally, a gauze square scented with parent's skin will be used to provide olfactory stimulation.

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 Parent-Supported Multisensory Neurorehabilitative Intervention focuses on enhancing brain multisensory processing by providing structured sensory experiences that mimic the natural environment. This approach helps premature infants develop better sensory integration, which is crucial for their overall brain maturation. Similar treatments often involve controlled exposure to auditory, visual, and tactile stimuli to promote neural connectivity and cognitive development. These mechanisms are vital for premature babies as they help mitigate the adverse effects of early sensory deprivation, leading to improved long-term language and motor outcomes.
Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,688 Previous Clinical Trials
2,602,697 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,228,284 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,798 Previous Clinical Trials
8,141,277 Total Patients Enrolled

Media Library

Contingent parent's voice exposure Clinical Trial Eligibility Overview. Trial Name: NCT03232931 — N/A
Premature Baby Research Study Groups: Multisensory Intervention, Standard of Care
Premature Baby Clinical Trial 2023: Contingent parent's voice exposure Highlights & Side Effects. Trial Name: NCT03232931 — N/A
Contingent parent's voice exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT03232931 — N/A
~36 spots leftby Oct 2025