Status:
COMPLETED
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
University of Southern California
Conditions:
Premature Birth of Newborn
Eligibility:
All Genders
Up to 32 years
Phase:
NA
Brief Summary
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions...
Detailed Description
Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of devel...
Eligibility Criteria
Inclusion
- Preterm Infants:
- A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
- Infant is less than or equal to 7 days old when approached about the study.
- Parents:
- Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
Exclusion
- Preterm Infants:
- Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV, TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)
- Infants that are wards of the state, or become wards of the state after enrolling in the study. Any data collected beginning at the time the state obtains custody onward will not be used in the research study.
- Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the significant variation in sensory exposure among those infants, and also to provide consistency during the hospital's impending transition to strictly private rooms in the very near future).
- Parents:
- Parents with limited or no understanding of the English Language
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03316547
Start Date
August 16 2017
End Date
November 1 2019
Last Update
July 7 2021
Active Locations (1)
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1
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110