Status:
COMPLETED
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Infant
Eligibility:
All Genders
32-36 years
Phase:
NA
Brief 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 sensor...
Detailed Description
This study is a randomized controlled trial design with intent-to-treat analysis in hospitalized preterm infants between 32 and 36 weeks post-menstrual age. Both the control and intervention groups wi...
Eligibility Criteria
Inclusion
- Hospitalization at a study location
- Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation
Exclusion
- 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
Key Trial Info
Start Date :
October 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03232931
Start Date
October 29 2018
End Date
April 25 2025
Last Update
May 13 2025
Active Locations (3)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205