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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years (22-26 months corrected age)

Awards & highlights

Study Summary

This trial will use rigorous scientific methods to study the effects of a parent-supported multisensory neurorehabilitative intervention for preterm infants. The intervention is designed to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years (22-26 months corrected age)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Index of Multisensory Processing (IMP)

Secondary outcome measures

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 outcome measures

Secondary Study: Contingent speech sound learning in infants

WECS

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,325 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,255 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,331 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently accepting participants?

"Affirmative. Based on information from clinicaltrials.gov, this trial is actively enrolling participants and was originally posted on October 29th 2018 with the most recent update occurring in January of 2022. The study requires 230 total patients across 2 sites."

Answered by AI

Does my profile meet the criteria to join this clinical trial?

"Those hoping to be admitted into this study must have been born preterm, between 32 and 36 Weeks of gestation. Currently, the trial is looking for 230 participants in total."

Answered by AI

What sample size is being observed in this clinical exploration?

"Affirmative. The information posted on clinicaltrials.gov states that this medical research project is currently recruiting participants, with the initial post dating back to October 29th 2018 and most recent revisions made on January 31st 2022. 230 volunteers are needed for the trial at 2 separate research centres."

Answered by AI

Is the minimum age for this clinical research trial set at 20 years old?

"To be eligible to partake in this trial, patients must fall within the 32-36 week age range. This research involves 186 trials for minors and 75 studies on elderly persons over 65 years of age."

Answered by AI

Recent research and studies

BMC PediatricsJournal

Randomized Controlled Trial Protocol to Improve Multisensory Neural Processing, Language and Motor Outcomes in Preterm Infants

Neel, Mary Lauren, Paul Yoder, Pawel J. Matusz, Micah M. Murray, Ashley Miller, Stephanie Burkhardt, Lelia Emery, et al.. 2019. “Randomized Controlled Trial Protocol to Improve Multisensory Neural Processing, Language and Motor Outcomes in Preterm Infants”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/s12887-019-1455-1.

The Journal of PediatricsJournal

Randomized Trial to Increase Speech Sound Differentiation in Infants Born Preterm

Richard, Celine, Arnaud Jeanvoine, Ann R. Stark, Kaleigh Hague, Caitlin Kjeldsen, and Nathalie L. Maitre. 2022. “Randomized Trial to Increase Speech Sound Differentiation in Infants Born Preterm”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2021.10.035.

The Journal of PediatricsJournal

Randomized Trial to Increase Speech Sound Differentiation in Infants Born Preterm

clinicaltrials.govStudy

Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants