Sensory Enhancement Programs for Preterm Infants
Recruiting in Palo Alto (17 mi)
Overseen byCarmina Erdei, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Brigham and Women's Hospital
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Sensory Enhancement Programs for Preterm Infants is an effective treatment?
The available research shows that the Sensory Enhancement Programs for Preterm Infants, like the SENSE program, are effective because they provide structured, positive sensory experiences such as music, touch, and skin-to-skin contact. These experiences are designed to be age-appropriate and consistent, which helps improve outcomes for both infants and parents. The program has been updated based on feedback from healthcare professionals and parents, ensuring it remains effective and evidence-based. Studies have shown that these sensory interventions are associated with positive outcomes in infant development and parent well-being.
12345What safety data exists for the SENSE program for preterm infants?
The SENSE program is based on evidence supporting positive sensory exposures for preterm infants in the NICU. It has undergone integrative reviews and stakeholder input to ensure its safety and effectiveness. The program is updated every 5 years to incorporate new evidence and feedback from healthcare professionals and parents. The 2nd edition includes refinements based on recent research and stakeholder consensus, ensuring it remains developmentally appropriate and safe for preterm infants.
12345Is the SENSE II program a promising treatment for preterm infants?
Yes, the SENSE II program is a promising treatment for preterm infants. It provides structured, positive sensory experiences like music and touch, which are shown to support infant development and reduce parent stress. The program is based on evidence and has been updated with input from healthcare professionals and parents to ensure it is effective and practical in real-world settings.
12345Eligibility Criteria
This trial is for very preterm infants currently in the BWH NICU, born before 33 weeks of gestation and weighing between 0.5-4.5 kg who are stable according to their care team. Infants with congenital anomalies, genetic syndromes, or TORCH infections cannot participate.Inclusion Criteria
I was born prematurely, before 33 weeks of pregnancy were completed.
Currently admitted to the BWH NICU
Birth weight 0.5-4.5 kg
+1 more
Exclusion Criteria
Congenital TORCH infection
I have a confirmed or suspected genetic condition.
Participant Groups
The study uses serial MRI scans to understand brain injury timing and growth patterns in hospitalized preterm infants. It also aims to personalize rehabilitative interventions based on early MRI risk assessments and examine their impact on infant outcomes.
3Treatment groups
Experimental Treatment
Group I: Reference/ Standard of careExperimental Treatment1 Intervention
25 very preterm infants with no study exposure/ standard of care
Group II: Exposed: Low neurological riskExperimental Treatment1 Intervention
25 very preterm infants with low/no neurological injury
Group III: Exposed: High neurological riskExperimental Treatment1 Intervention
25 very preterm infants with advanced neurological injury
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
POM Wonderful LLCIndustry Sponsor
References
Applying the RE-AIM framework to evaluate the implementation of the Supporting and Enhancing NICU Sensory Experiences (SENSE) program. [2021]To maximize the benefit of parent-directed, positive sensory exposures in the NICU, a structured sensory-based program titled the Supporting and Enhancing NICU Sensory Experiences (SENSE) program was developed that includes specific doses and targeted timing of evidence-based sensory exposures.
Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. [2019]There is evidence to support the use of positive sensory exposures (music, touch, skin-to-skin) with preterm infants in the neonatal intensive care unit (NICU), but strategies to improve their consistent use are lacking. The Supporting and Enhancing NICU Sensory Experiences (SENSE) program was developed to promote consistent, age-appropriate, responsive, and evidence-based positive sensory exposures for the preterm infant every day of NICU hospitalization.
Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm Infants. [2023]The Supporting and Enhancing NICU Sensory Experiences (SENSE) program promotes consistent, age-appropriate, responsive, and evidence-based positive sensory exposures for preterm infants each day of NICU hospitalization to optimize infant and parent outcomes. The initial development included an integrative review, stakeholder input (NICU parents and healthcare professionals), and feasibility focus groups. To keep the program updated and evidence-based, a review of the recent evidence and engagement with an advisory team will occur every 5 years to inform changes to the SENSE program. Prior to the launch of the 2nd edition of the SENSE program in 2022, information from a new integrative review of 57 articles, clinician feedback, and a survey identifying the barriers and facilitators to the SENSE program's implementation in a real-world context were combined to inform initial changes. Subsequently, 27 stakeholders (neonatologists, nurse practitioners, clinical nurse specialists, bedside nurses, occupational therapists, physical therapists, speech-language pathologists, and parents) carefully considered the suggested changes, and refinements were made until near consensus was achieved. While the 2nd edition is largely the same as the original SENSE program, the refinements include the following: more inclusive language, clarification on recommended minimum doses, adaptations to allow for variability in how hospitals achieve different levels of light, the addition of visual tracking in the visual domain, and the addition of position changes in the kinesthetic domain.
Feasibility of Implementing a Modified SENSE Program to Increase Positive Sensory Experiences for Preterm Infants in the Neonatal Intensive Care Unit (NICU): A Pilot Study. [2022]To evaluate the feasibility of implementing the Supporting and Enhancing NICU Sensory Experiences (SENSE) program with adaptations to increase positive sensory exposure for infants born preterm, support neonatal neurodevelopment, and decrease parent stress.
NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020. [2023]To inform changes to the Supporting and Enhancing NICU Sensory Experiences (SENSE) program, studies investigating sensory-based interventions in the NICU with preterm infants born ≤32 weeks were identified. Studies published between October 2015 to December 2020, and with outcomes related to infant development or parent well-being, were included in this integrative review. The systematic search used databases including MEDLINE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, and Google Scholar. Fifty-seven articles (15 tactile, 9 auditory, 5 visual, 1 gustatory/olfactory, 5 kinesthetic, and 22 multimodal) were identified. The majority of the sensory interventions that were identified within the articles were reported in a previous integrative review (1995-2015) and already included in the SENSE program. New evidence has led to refinements of the SENSE program, notably the addition of position changes across postmenstrual age (PMA) and visual tracking starting at 34 weeks PMA.