Multisensory Intervention for Prematurity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special treatment for preterm babies to assess its impact on brain development and their response to sensory experiences, such as touch and sound. The treatment uses a parent's voice and gentle touch to support the baby's growth, even when the parent is not present. Methods include contingent parent's voice exposure, parental skin-to-skin care, recorded parent's voice, and therapist skin-to-skin care. Babies in the NICU (Neonatal Intensive Care Unit) between 32 and 36 weeks of gestation are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve care for preterm infants.

Do I need to stop taking my current medications for the trial?

The trial excludes participants who are using sedatives or seizure medications, so you would need to stop these medications to participate.

What prior data suggests that this multisensory intervention is safe for preterm infants?

Research shows that using a parent's voice, whether live or recorded, is safe and beneficial for premature babies. Studies have found that babies respond well to their mother's voice, aiding their focus and feeding. This method appears harmless and may even calm the babies.

Similarly, skin-to-skin contact, whether from a parent or a therapist, is generally safe and well-received. Studies emphasize its safety and benefits, such as improved bonding and emotional balance. Premature babies who experience skin-to-skin contact often develop better social skills and growth over time. Overall, both voice exposure and skin-to-skin contact are safe and supportive for premature babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which involves regular skin-to-skin holding and exposure to recordings of a parent's voice, the multisensory intervention offers a more integrated experience for preterm infants in the NICU. This treatment uniquely combines the soothing effects of a mother's voice played in response to the infant's pacifier sucking, along with tactile stimulation from the therapist's gentle holding and a scent of the parent's skin to engage multiple senses at once. Researchers are excited about this approach because it has the potential to enhance sensory development by providing a more immersive and responsive environment for the infant, potentially improving outcomes during a critical period of growth.

What evidence suggests that this trial's multisensory interventions could be effective for preterm infants?

This trial will compare a multisensory intervention with standard care for preterm infants. Research has shown that preterm babies benefit from hearing their parent's voice. Specifically, one study found that when babies heard their mother's voice, they experienced a 29% reduction in the time between sucking bursts, indicating increased focus and attention. Holding the baby against the chest, known as skin-to-skin care, has also improved brain development. Babies with more skin-to-skin contact scored higher on developmental tests at 12 months. These practices help preterm babies develop better sensory processing and may enhance their language and motor skills in the long term. ^{1 2 3 6 7}

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

My family has a history of genetic hearing loss.

I am currently taking sedatives or medications for seizures.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468415/

Mother–Preterm Infant Contingent Interactions During ... We demonstrate feasible behavioral scales to measure contingency between mothers and preterm infants' behaviors during supported infant-directed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11473331/

Early parental vocal contact in neonatal units This paper aims to present clear and evidence-based proposals for the integration of Early Parental Vocal Contact into the clinical practices of neonatal units.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/mbe.70000?af=R

Contingent Mother's Voice Intervention Facilitates Attention ... Pause time between suck bursts was 29% lower for infants receiving contingent mother's voice compared to passive exposure (p < 0.001).

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818754

Music Therapy in Infancy and Neurodevelopmental ... Parent-led, infant-directed singing compared with standard care did not result in greater language development benefits at 24 months' corrected age in preterm ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06063122

Development of a Therapeutic Device to Improve Speech ... The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10605591/

Contingent Mother's Voice Intervention Targeting Feeding ... This study aimed to determine whether an NNS-training protocol using the mother's voice as positive reinforcement and validated in preterm ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163638323000516

The effects of live parental infant-directed singing on ... Infant-directed singing impacts on: infants' emotional regulation, provides validation of the parent's role, and promotes affect attunement within the dyad.