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NCT05230199 · ClinicalTrials.gov registry record · NA
Sensory Optimization of the Hospital Environment
A NA study of Parent-Child Relations and Parents, sponsored by University of Southern California.
- Recruiting
- Registry status
- NA
- Development phase
- 215
- Enrollment target
- 1
- Study location
NCT05230199: Recruiting NA study of Parent-Child Relations and Parents, sponsored by University of Southern California.
NCT05230199 is a NA study of Parent-Child Relations and Parents that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 215 participants, below the 316-participant average among 38 other Parent-Child Relations trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05230199, a NA study of Parent-Child Relations and Parents, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
- 1
- Study location
Study Summary
The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.
Primary Outcome
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
Conditions Studied
Interventions
- BEHAVIORAL SENSE multisensory program
- BEHAVIORAL Monitored standard of care
Study Locations (1)
Missouri
- Cardinal Glennon Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2023-05-29 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT05230199 shows while recruiting
NCT05230199 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 316-participant average among 38 other Parent-Child Relations trials with a reported enrollment target (32% lower).
The record links to 5 conditions, with Parent-Child Relations appearing as the primary indexed condition, and to 2 interventions - of which SENSE multisensory program is the first listed.
NCT05230199 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05230199 about?
NCT05230199 is a clinical study titled "Sensory Optimization of the Hospital Environment". The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a r...
What is the current status of trial NCT05230199?
This trial is currently recruiting. It is a NA study. The enrollment target is 215 participants. The study started on 2023-05-29. Estimated completion is 2027-08-31.
What conditions does trial NCT05230199 study?
This clinical trial studies the following conditions: Parent-Child Relations, Parents, Pre-Term, Development, Infant, Sensory Integration Dysfunction.
What interventions are being tested in trial NCT05230199?
The interventions under investigation include: SENSE multisensory program (BEHAVIORAL), Monitored standard of care (BEHAVIORAL).
Who is sponsoring clinical trial NCT05230199?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05230199 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05230199's enrollment target sits among peer trials
215 15th of 38 higher than 24 of 38 other Parent-Child Relations trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parent-Child Relations trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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