CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
SENSE Programother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03316547
NCT03316547N/ACompleted

Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants

Washington University School of Medicine·interventional·Posted Oct 20, 2017·Updated Jul 7, 2021

In Brief

A clinical study evaluating SENSE Program for Premature Birth of Newborn. Completed, enrolled 70 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartAug 16, 2017
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.7 years ago

Interventions

SENSE Programother

Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises \[passive range of motion (PROM), gentle stretching\]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.