Research Project
10009647
This Phase II SBIR finalizes development and commercializes BabyGentleStick (BGS), a device designed to reduce pain and stress of heel sticks through vibration-induced anesthesia. BGS delivers vibration via a commercially available heel stick lancet to the target area, effectively numbing/masking pain signals prior to and during lancing. Phase I demonstrated compelling reductions in pain response in clinical evaluations. 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. Heel sticks are considered one of the most frequent painful procedures performed in the neonatal intensive care unit (NICU), resulting in a repeated pain response that negatively impacts development. This pain 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. 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. A solution is needed that provides drug-free reduction of the pain and stress responses to heel sticks and post-lance heel squeezing in neonates. BGS achieves these aims and meets the NIH/NICHD goals of ?Innovative ideas to reduce stress for the staff, parents and infants in the NICU? and ?Methods to reduce pain in all of perinatal care in newborn infants, in mothers in labor, during postpartum after spontaneous delivery and cesarean section.? The innovation is the combination of vibration-induced anesthesia with a high-speed automatic lance in a single easy-to-use Handpiece, without compromising blood sample quality or volume. Phase II Hypothesis. BGS is safe and effective for reducing pain and stress responses during neonatal heel stick procedures. Specific Aims. Aim 1 ? Incorporate design improvements from Phase I, conduct usability validation, and reach Design Freeze for BGS. Regulatory discussions with FDA. Acceptance Criteria. BGS accepts incision-style lancets most commonly used for heel stick collections in the U.S. A usability study with clinicians at HMC and NCH confirms design changes and usability. Aim 2 ? Transition BGS toward clinical studies, Regulatory Submission, and Manufacturing. Acceptance Criteria. Successful completion of Verification and Validation (V&V). FDA approval of Investigational Device Exemption (IDE). Clinical Supplies Manufactured. Aim 3 ? Demonstrate reduction in pain and stress response through clinical studies (Nationwide Children?s and Hershey Medical Center) and prepare Regulatory Submission. Acceptance Criteria. BGS significantly reduces pain response during lance as well as behavioral indications of distress during the post-lance heel squeeze in neonates. BGS Regulatory clearance.
