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

75 Participants Needed

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.

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.

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. ^{1 2 3 4 5}

What data supports the effectiveness of the SENSE II treatment for preterm infants?

The SENSE II program is based on evidence that positive sensory experiences, like music and touch, can benefit preterm infants in the NICU by supporting their development and reducing parent stress. The program is regularly updated with new research and feedback from healthcare professionals to ensure it remains effective and relevant. ^{1 2 3 4 5}

What 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. ^{1 2 3 4 5}

Is the SENSE program safe for preterm infants?

The SENSE program, which provides positive sensory experiences like music and touch for preterm infants in the NICU, has been developed with input from healthcare professionals and parents to ensure it is safe and appropriate. It is based on evidence and regularly updated to maintain safety and effectiveness. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

How is the SENSE II treatment different from other treatments for preterm infants?

The SENSE II program is unique because it provides structured, evidence-based sensory experiences tailored to the developmental needs of preterm infants in the NICU, focusing on consistent, age-appropriate sensory exposures like touch and music to support neurodevelopment and reduce parent stress. ^{1 2 3 4 5}

Research Team

Carmina Erdei, MD

Principal Investigator

Brigham and Women's Hospital and Harvard Medical School

Eligibility 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

Exclusion Criteria

Congenital TORCH infection

I have a confirmed or suspected genetic condition.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Applying the RE-AIM framework to evaluate the implementation of the Supporting and Enhancing NICU Sensory Experiences (SENSE) program. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Supporting and Enhancing NICU Sensory Experiences (SENSE), 2nd Edition: An Update on Developmentally Appropriate Interventions for Preterm Infants. [2023]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

NICU sensory experiences associated with positive outcomes: an integrative review of evidence from 2015-2020. [2023]