N/A N=248 Randomized Single-blind Treatment

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

Preterm Infant

Bottom Line

View on ClinicalTrials.gov: NCT03232931 ↗

Enrolled (actual)

248

Serious AEs

0.4%

Results posted

Mar 2024

Primary outcome: Primary: Index of Multisensory Processing (IMP) — 31.4; 49.0; 35.6; 18.8 percentage of time

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Therapist skin-to-skin Care (Behavioral); Contingent parent's voice exposure (Device); Parental skin-to-skin care (Behavioral); Recorded parent's voice (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Index of Multisensory Processing (IMP)	31.4; 49.0; 35.6; 18.8	—
SECONDARY Infant/Toddler Sensory Profile (ITSP) Score	—	—
SECONDARY Change in Bayley Scales of Infant and Toddler Development - 3rd Edition (Bayley III) Score	—	—
SECONDARY Change in Preschool Language Scales - 5th Edition (PLS-5) Score	—	—

Summary

Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth. This study uses rigorous scientific methods to measure the effects and determine the mechanisms of action of a parent-supported multisensory neurorehabilitative intervention for preterm infants, adaptable to a wide variety of neonatal environments, even when parents cannot be at their child's bedside. The intervention aims to improve brain multisensory processing, reactions to sensory stimulation in the home and long term language and motor development.

Eligibility Criteria

Inclusion Criteria

Hospitalization at a study location
Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation

Exclusion Criteria

Ventilation using an endotracheal tube
Major congenital malformations
Family history of genetic hearing loss
Use of sedatives or seizure medications

Secondary Study Inclusion Criteria:

Enrolled in the control group of the main study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03232931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.