Oscillated Needle System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates

DESCRIPTION provided by applicant This Phase I STTR in response to RFA HD andquot Non or Minimally Invasive Methods to Measure Biochemical Substances during Neonatal and Perinatal Patient Care and Researchandquot develops and tests Baby Gentle Stick BGS a handheld device to decrease the distress of repeat blood sampling in neonates BGS combines delivery of vibration induced anesthesia with oscillated lancet insertion to reduce heel stick pain Blood collection in neonates is routinely necessary with heel sticks penetration of capillary bed
with a sharp being the most common technique for small samples andlt L Heel sticks are one of the most frequent painful procedures performed in the NICU resulting in a repeated pain response believed to negatively impact development The pain associated with heel sticks has stimulated a multitude of studies aimed at developing strategies to alleviate discomfort including the use of oral sucrose glucose non nutritive sucking kangaroo care skin to skin contact electrical stimulation white noise breastfeeding music and massage Moreover clinical and laboratory studies suggest that preterm neonates are especially vulnerable and can exhibit sensitization to repeat stimuli Recently evidence for developmental plasticity in the neonatal brain suggests that repetitive painful experiences during this period or prolonged exposure to analgesic drugs may alter neuronal and synaptic organization permanently The significance of this STTR is that a device is needed that provides drug free reduction of the pain response while simultaneously improving success rates and sample volumes eliminating multiple attempts and reducing tissue damage The innovation of this STTR is the combination of vibration induced anesthesia with high speed automatic lance in a single handheld device that lances with less pain and trauma without compromising blood sample quality or volume Baby Gentle Stick achieves these aims and meets the NIH NICHD goal of andquot Innovative ideas to reduce stress for the staff parents and infants in the NICUandquot SBIR STTR Program Descriptions Phase I Hypothesis The pain response from the lancing event will be lessened with BGS leading to less stressful heel stick blood collection in neonates than current practice Specific Aims Aim Development of BGS with mechanical performance verifications AMI andamp Penn State University College of Medicine PSU Month Acceptance Criteria BGS hand piece meets all design requirements including being battery operated be compatible with a commercially available non blade lancet achieve vibration and reduction of force performance and incision consistency Aim Demonstrate BGS reduces pain of standard heel sticks AMI andamp PSU Month and Acceptance Criteria a Pilot Human Study with Healthy Adult Volunteers shows no adverse events reduced pain and receives positive clinician review b neonatal study n demonstrates reduced pain response facial pain scores and skin conductance response data while yielding functionally equivalent blood samples

PUBLIC HEALTH RELEVANCE Blood collection in neonates is common with heel sticks used for drawing small amounts of capillary blood Improper heel stick technique can damage the structures of the foot including the calcaneus bone and soft tissues The pain response is distressing to the child parents and staff in the Neonatal Intensive Care Unit A device is needed that enables controlled heel sticks while eliminating the pain response vasoconstriction and tissue damage Baby Gentle Stick provides a drug free reduction of the pain response while simultaneously improving success rates and sample volumes eliminating multiple attempts and reducing tissue damage