N/A
N=70
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Premature Birth of Newborn
Bottom Line
View on ClinicalTrials.gov: NCT03316547 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Ages and Stages Questionnaire (ASQ) - Communication at 1 Year — 38.6; 48.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SENSE Program (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ages and Stages Questionnaire (ASQ) - Communication at 1 Year |
38.6; 48.6 | — |
| PRIMARY Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age |
4.4; 4.1 | — |
| SECONDARY Language Environmental Acquisition Device (LENA) |
2.4; 3.9; 2.6; 3.7; 14.8; 14.3 | — |
| SECONDARY Sensory Exposures Provided During Hospitalization |
14; 24; 8; 15; 12; 12 | — |
| SECONDARY Dubowitz/Hammersmith Neonatal Neurological Evaluation |
22.8; 20.6 | — |
| SECONDARY General Movement Assessment (GMA) |
— | — |
| SECONDARY Discharge Questionnaire |
4.3; 4.8; 9.2; 8.1; 6.7; 5.6 | — |
| SECONDARY 1 Year Follow-Up Questionnaire |
11.9; 11.7; 20.8; 20.6; 20.1; 17.8 | — |
| SECONDARY Mother-Infant Interaction (at 1 Year Follow-up) |
17.8; 14.3 | — |
| SECONDARY Parent Engagement During Hospitalization |
3.9; 3.9; 3.7; 3.7; 1.6; 1.8 | — |
| SECONDARY Language Environmental Acquisition Device (LENA) Adult Word Count |
4618.1; 4338.5 | — |
| SECONDARY Percentage of Sensory Interventions Received |
80.5; 122.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT03316547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.