N/A
Completed N=248
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Source: ClinicalTrials.gov NCT03232931 ↗Enrolled (actual)
248
Serious AEs
0.4%
Results posted
Mar 2024
Primary outcomePrimary: Index of Multisensory Processing (IMP) — 31.4; 49.0; 35.6; 18.8 percentage of time
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.
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 |
— | — |
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
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. Informational only — not medical advice.