BGS Neonatal Pilot Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/12/2018 |
| Start Date: | November 6, 2017 |
| End Date: | December 2018 |
| Contact: | Kim Doheny, Ph.D. |
| Email: | kdoheny@hmc.psu.edu |
| Phone: | 717-531-1332 |
Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- 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.
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.
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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Phone: 717-531-1332
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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