What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Multisensory interventions for premature babies, such as those involving tactile, auditory, and visual stimuli, are generally safe and beneficial for reducing stress and promoting development. However, overstimulation can occasionally lead to increased stress or discomfort. Other common treatments, like respiratory support, can sometimes cause lung damage or infections, and nutritional support may lead to feeding intolerance or metabolic imbalances. These treatments are essential but require careful monitoring to minimize potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving outcomes for premature infants, particularly in the realm of neuroprotection and neurodevelopment. One notable approval is for magnesium sulfate, which has been shown to reduce the risk of cerebral palsy and substantial gross motor dysfunction in preterm infants. While specific FDA approvals for parent-supported multisensory neurorehabilitative interventions are not detailed, the focus on enhancing brain multisensory processing and development aligns with ongoing research and clinical trials aimed at improving long-term neurodevelopmental outcomes in this vulnerable population.

What other types of research exist?

Promising novel alternatives for premature infants include: 1) Developmental interventions combining hospital and home-based care, which have shown positive effects on mental development and caregiver-infant interactions. 2) Therapeutic hypothermia for neuroprotection in neonates with asphyxia or encephalopathy. 3) Early intervention programs focusing on enhancing parent-infant bonding and communication. These approaches aim to support neurodevelopment and improve long-term outcomes for preterm infants.

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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

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:

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My family has a history of genetic hearing loss.

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I am currently taking sedatives or medications for seizures.

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

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.

0 / 2Eligibility criteria met

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.