Multisensory Intervention for Prematurity
What You Need to Know Before You Apply
What is the purpose of this trial?
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 on the Research Team?
Nathalie Maitre, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a multisensory intervention in the NICU, including auditory-tactile stimulation with recorded mother's voice and tactile containment, over a 2 to 3 week period.
Follow-up
Participants are monitored for neurodevelopmental outcomes at NICU Follow-Up Program clinics.
Optional Secondary Study
Participants may opt into additional ERP testing sessions in the NICU and clinical laboratory.
What Are the Treatments Tested in This Trial?
Interventions
- Contingent parent's voice exposure
- Parental skin-to-skin care
- Recorded parent's voice
- Therapist skin-to-skin Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Nationwide Children's Hospital
Collaborator
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator