Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Completed
NCT Number: NCT03066895
BGS Neonatal Pilot Study
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
35 week–42 week
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth
- Sex: male or female
Exclusion criteria
- Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
- Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
- Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
- Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
- Critical illness in the mother preventing the ability to obtain informed consent from parents
Treatment and study plan
BabyGentleStick
DeviceExperimental device.
Standard Lancing Device
DeviceHMC standard of care.
Primary outcomes
-
Adverse events
Time frame: Up to 8 days
No device-attributable adverse events.
Secondary outcomes
-
Pain Response
Time frame: 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure
Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale
Sponsors and collaborators
Lead sponsor
Actuated Medical, Inc.
Industry
Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Milton S. Hershey Medical Center
- National Institutes of Health (NIH)
Registry information
Official study title
Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study
Important dates
- Study start
- 2017
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Mar 1, 2017
- Registry last updated
- Sep 14, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.