Multisensory Intervention for Prematurity

Recruiting at 3 trial locations

Overseen By Nathalie Maitre, MD,PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Sedatives, Seizure medications

Disqualifiers: Ventilation, Congenital malformations, Genetic hearing loss

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 2-3 weeks

248 Participants Needed

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

Hospitalization at a study location

My baby was born between 32 and 36 weeks of pregnancy.

Exclusion Criteria

I am currently taking sedatives or medications for seizures.

My family has a history of genetic hearing loss.

Major congenital malformations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

2-3 weeks

12 to 23 sessions in NICU

Follow-up

Participants are monitored for neurodevelopmental outcomes at NICU Follow-Up Program clinics.

22-24 months

Visits at 9-12 months and 22-24 months PMA

Optional Secondary Study

Participants may opt into additional ERP testing sessions in the NICU and clinical laboratory.

3-4 months

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 2 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 Intervention Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+