IPI Awarded NEPDC Grant for ShapeTape

The Institute for Pediatric Innovation (IPI) is proud to announce that it has been the recipient of a grant from the New England Pediatric Device Consortium (NEPDC) for ShapeTape, a pre-cut therapeutic kinesiology tape used to stabilize the ET tube to reduce the occurrence of unplanned extubations (UEs).

The award will go towards obtaining clinician input and expertise to determine the optimal product shapes and sizes. Additionally, the grant will be used to analyze potential commercial partners.

For more information, check out our press release on PRWeb.

Clinical Innovation Catalyst Program Addresses Pediatric Adverse Drug Events

The Institute for Pediatric Innovation (IPI) is pleased to announce that the 2017-2018 Clinical Innovation Catalyst Program is focusing on Adverse Drug Events (ADEs). 

American Society for Health-System Pharmacists defines an ADE as "any unexpected, unintended, undesired, or excessive response to a drug." This hospital acquired condition can result in prolonging the patient's stay in a healthcare facility, permanent harm, disability and even death. Healthcare providers may be penalized by payors for ADEs, receive negative publicity, and be exposed to litigation. 

ADEs can be especially life threatening for newborns and young children since this population is usually less able to physiologically tolerate a medical error due to their still-developing renal, immune and liver functions. Pediatric ADEs are also problematic because children may not be able to effectively communicate any adverse effects a medication is causing.

For more information, check out our press release on PRWeb.

Study of practices for obtaining assent of pediatric patients in clinical trials just published

The Institute for Pediatric Innovation (IPI) announces that the Journal of Therapeutic Innovation & Regulatory Science has just published the results of a study on practices for obtaining the assent of pediatric patients who are asked to participate in clinical trials.

This study, entitled “Industry and Patient Perspectives on Child Participation in Clinical Trials,” is a result of a collaboration among IPI, biopharmaceutical companies Pfizer and Shire and healthcare communications firm The Medicine Group. Coauthors on the study are Irmgard Eichler, Stephanie Gilstein, Donald Lombardi, Philip Sjostedt, Liza Squires, Charles Thompson and Mark Turner.

The issue of obtaining assent of pediatric patients has long been seen as a challenge in the medical world, especially since the introduction of new regulations in the early 2000s. Although children cannot generally provide legal informed consent until they reach adulthood, they need to be given age-appropriate information and asked to agree to participate in clinical trials.

The study focused on determining how varying stakeholders dealt with ambiguities inherent in the assent requirements and the differences observed among patients from a range of ages and populations, cultures, clinical trial types and regulatory environments.

Launched in 2014, the study centered around digital surveys offered both in the United States and internationally. The first survey polled children, parents and/or caregivers while the second was aimed at clinical trial professionals on their organizations’ experiences and policies regarding pediatric assent.

Forty-five respondents completed the child and parent/caregiver survey. Fifty-seven individuals completed the industry survey. Survey respondents offered their experiences of clinical trials and challenges they encountered to secure assent. Common obstacles included language barriers, cultural issues, disease severity and child maturity.

Respondents also surfaced potential solutions. Both children and parents/caregivers called for visual aids that would clearly explain the procedure while retaining a child’s attention. The study reports that standardized practices and tools would help pediatric patients make well-informed decisions about their participation in clinical trials. Such tools would establish a baseline standard for the assent process.

The results of the surveys indicate that a shift in handling management of child assent can provide relief for parents and children in a hospital setting.

If you are interested in reading the article, visit the online journal.

Participants in IPI’s Catalyst Program Develop Solutions for Unplanned Extubations in Babies and Children

 2017 Participants at Shriners Hospitals for Children

2017 Participants at Shriners Hospitals for Children

This year, participants in the Institute for Pediatric Innovation’s (IPI) Clinical Innovation Catalyst program focused on finding product improvements that could reduce the occurrence of unplanned extubations (UEs).

Pediatric patients have tubes placed in their throats when they need help breathing or to provide medication. Sometimes, patient movement can cause unplanned UEs which is when these tubes become dislodged or removed, resulting in situations that can prolong treatment or even become life threatening. In addition to additional treatment time and potential airway trauma, these conditions can add an average of 6.5 days to a hospital stay and up to $37,000 per case in pediatrics.

IPI’s Catalyst program, a professional education experience and training program for nurses and allied health professionals, addresses hospital acquired conditions to improve safety and outcome. Innovation concepts are developed based upon these clinicians’ vast experience, education, practice and input from patients, families and other caregivers to generate new devices and technology for pediatric hospitals. Each year, IPI’s member hospitals choose a new hospital acquired condition on which to focus.

Selected participants from member hospitals— Shriners Hospital for Children Northern California, Stanford Children’s Health, Texas Children’s Hospital and University Hospitals Rainbow Babies & Children’s Hospital—participate in four workshops each focused on a different aspect of the innovation process. Workshop topics include problem identification, content development, concept refinement/selection and business planning. At the conclusion of the four workshops, participants deliver fully developed product concepts.

During this year’s cycle, the team of three respiratory therapists, two nurses and one parent developed three product concepts: ShapeTape, HoldET and Flo-Frame to reduce the outcome of UEs.  

The first product concept presented was ShapeTape, a precut therapeutic kinesiology tape used to stabilize the ET tube. This durable tape, adapted from other healthcare uses, is specially precut to adapt to a baby’s face and withstands patient movement and adverse environments. Participants assessed the business opportunity, noting its lower cost against competitors and potential to decrease UEs by 20%.

HoldET reinvents an existing ETT holder by adding adjustable straps to securely fit pediatric patients. The product will decrease UEs by an estimated 10%.

The final product concept, Flo-Frame, included improved fixation of the tubes to the patients, a re-invention of current tube holder design, and system to more easily move with the patient. It is estimated that the device will decrease UEs by as much as 10%.  

IPI is currently seeking commercialization partners to continue ongoing product development and commercialization of these concepts.

 “This program enables bedside providers to make smart, significant and most of all, useful changes to well-known healthcare problems,” said Catalyst participant Jennifer Michals.

The final product concepts highlight participant dedication to finding effective solutions to the many challenges encountered in pediatric hospitals.


IPI Awarded Grant for New Alcohol Wipe Development

 Catalyst participants visit Shriners Hospital for Children - Northern California.

Catalyst participants visit Shriners Hospital for Children - Northern California.

Huge thank you to the New England Pediatric Device Consortium for awarding IPI a grant to develop a new alcohol wipe. Participants from our four consortium hospitals designed four products in last year's Catalyst Program.

The 2015-2016 catalyst program cycle focused on the reduction of central line-associated bloodstream infections (CLABSIs) in pediatric hospital settings. These occur when a patient develops a bloodstream infection after receiving a catheter, or central line, run through a vein into the vena cava. CLABSIs are among the most common hospital-acquired conditions and cost hospitals billions of dollars each year.

For more information, check out our press release on PRWeb.