Sensory Enhancement Programs for Preterm Infants

Overseen By Yvonne Sheldon, RN, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Congenital anomaly, Genetic syndrome, TORCH infection

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sensory programs in the NICU (neonatal intensive care unit) can aid the brain development of very preterm infants. Researchers use MRI scans to determine when and why brain injuries occur and how the brain develops in these infants. The goal is to assess whether early MRIs can predict which babies might benefit most from specific treatments, such as the SENSE-plus program (Supporting and Enhancing NICU Sensory Experiences 2nd Edition), and how these treatments impact their recovery both in the short and long term. The trial seeks very preterm infants born before 33 weeks, weighing between 0.5 and 4.5 kg, and in stable condition in the NICU. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance care for future 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical care team overseeing the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SENSE II program, which enhances sensory experiences for premature babies in the NICU, is generally well-tolerated. Studies have found that this program provides safe and positive sensory experiences for infants. Existing research has reported no serious side effects from the interventions. The program offers sensory experiences tailored to the infants' age and needs, prioritizing their safety. Although specific safety data is limited, the program's nature suggests a low risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these sensory enhancement programs because they aim to enrich the early developmental environment for preterm infants, who often face unique challenges. Unlike the standard care, which primarily focuses on medical stability, the SENSE-plus and SENSE programs integrate specific sensory experiences to promote brain development. These programs offer a structured approach to sensory exposure, which could potentially lead to better neurological outcomes by enhancing the infants' sensory environment during a critical period of brain growth.

What evidence suggests that the SENSE II program could be effective for preterm infants?

Research shows that the SENSE II program, a treatment in this trial, is designed to create positive sensory experiences for premature babies in the NICU. Studies have found that this program helps improve brain development in these infants. The SENSE II program provides structured, age-appropriate sensory activities, crucial for the brain growth of preterm babies. Early results suggest that involving families in these activities can enhance the babies' growth and development. By focusing on consistent, research-backed sensory inputs, the program aims to support the delicate developmental needs of these infants. Participants in this trial may receive either the SENSE II program or standard care, which serves as the control group. ^{1 2 3 4 6}

Who Is on the Research Team?

Carmina Erdei, MD

Principal Investigator

Brigham and Women's Hospital and Harvard Medical School

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I have a confirmed or suspected genetic condition.

Congenital TORCH infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive serial brain MRI scans approximately every 2 weeks to monitor brain growth and evolution of injury throughout NICU hospitalization

3 months

At least 3 MRI scans

Follow-up

Participants are monitored for neurodevelopmental outcomes and family functioning at NICU discharge and up to 2 years corrected age

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Reference/ Standard of care
• SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program
• SENSE: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program

Trial Overview 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.

How Is the Trial Designed?

Group I: Reference/ Standard of care Experimental Treatment 1 Intervention

25 very preterm infants with no study exposure/ standard of care

Group II: Exposed: Low neurological risk Experimental Treatment 1 Intervention

25 very preterm infants with low/no neurological injury

Group III: Exposed: High neurological risk Experimental Treatment 1 Intervention

25 very preterm infants with advanced neurological injury

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

POM Wonderful LLC

Industry Sponsor

Trials

15

Recruited

1,700+

Published Research Related to This Trial

The SENSE program, designed for preterm infants in the NICU, significantly increased the amount of tactile and auditory sensory exposures compared to standard care, with 91% of targets met versus 48% in the control group.

The program was well-received by parents, with 95% of infants tolerating it and 85% of sensory interventions being conducted by parents, indicating high acceptability and engagement in the sensory experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the RE-AIM framework to evaluate the implementation of the Supporting and Enhancing NICU Sensory Experiences (SENSE) program. Pineda, R., Roussin, J., Kwon, J., et al.[2021]

The SENSE program, aimed at enhancing sensory experiences for preterm infants, showed high feasibility with an 87.5% recruitment rate and 100% retention among the eight infants studied, indicating strong interest and commitment from families.

Post-assessment results indicated that the program effectively reduced parent stress and supported normal neurodevelopment in infants, suggesting that SENSE could be beneficial for both infants and their parents in the NICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. de Castro, KN., Benson, JD., Thomas, H., et al.[2022]

The SENSE program, designed for preterm infants in the NICU, emphasizes consistent and evidence-based sensory experiences to improve outcomes for both infants and parents, with updates informed by a comprehensive review of 57 articles and stakeholder feedback.

The 2nd edition of the SENSE program includes refinements such as more inclusive language and specific recommendations for sensory exposure, ensuring it remains relevant and effective in real-world hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm Infants. Pineda, R., Kellner, P., Ibrahim, C., et al.[2023]

A review of 57 studies on sensory-based interventions for preterm infants in the NICU revealed that most interventions were already part of the existing SENSE program, indicating a solid foundation of evidence for these practices.

New findings prompted updates to the SENSE program, including the introduction of position changes based on postmenstrual age and the initiation of visual tracking activities starting at 34 weeks PMA, enhancing developmental support for these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020. Pineda, R., Kellner, P., Guth, R., et al.[2023]

The SENSE program was developed to provide consistent and evidence-based positive sensory experiences for preterm infants in the NICU, utilizing strategies like music and skin-to-skin contact.

Implementation materials for the SENSE program include tailored sensory exposure guidelines and parent education, but further research is needed to evaluate its effectiveness on outcomes for both parents and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. Pineda, R., Raney, M., Smith, J.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10297666/

Supporting and Enhancing NICU Sensory Experiences ... The SENSE program was designed to promote daily, positive, and evidence-based sensory experiences for premature infants who spend their first ...

2. chan.usc.edu chan.usc.edu/nicu/sense

SENSE® Supporting & Enhancing NICU Sensory Experiences The SENSE® program provides education to engage families in providing developmentally appropriate positive sensory exposures to optimize outcomes for their ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03316547

Supporting and Enhancing NICU Sensory Experiences ... The aim of this randomized clinical trial was to assess the effect of a sensory-based intervention in the NICU on outcomes of preterm infants and their families ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524000909

Enhancing Sensory Experiences for Infants Born Preterm SENSE was created to provide dosed multimodal sensory interventions to support neurodevelopment in medically fragile infants.

5. researchgate.net researchgate.net/publication/371122451_Supporting_and_Enhancing_NICU_Sensory_Experiences_SENSE_2nd_Edition_An_Update_on_Developmentally_Appropriate_Interventions_for_Preterm_Infants

Supporting and Enhancing NICU Sensory Experiences ... The Supporting and Enhancing NICU Sensory Experiences (SENSE) program promotes consistent, age-appropriate, responsive, and evidence-based ...

6. mdpi.com mdpi.com/2227-9067/10/6/961/review_report

Supporting and Enhancing NICU Sensory Experiences ... Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm ...