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Supporting and Enhancing NICU Sensory Experiences (SENSE)

NCT03316547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-07-07

Study results available
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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.

Conditions

  • Premature Birth of Newborn

Interventions

OTHER

SENSE Program

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.

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Roberta G Pineda, PhD, OTR/L · Washington University School of Medicine; University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316547 on ClinicalTrials.gov