Supporting and Enhancing NICU Sensory Experiences (SENSE)
Completed · Not applicable
Conditions studied: Premature Birth of Newborn
In brief
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 at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.
Key facts
- Study ID
- NCT03316547
- Run by
- Washington University School of Medicine
- People needed
- 70
- Starts
- 2017-08-16
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2021-07-07
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- St. Louis Children's Hospital — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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