Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study

Actuated Medical, Inc.1 site in 1 country20 target enrollmentNovember 6, 2017

ConditionsPain From Heel Sticks

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain From Heel Sticks
Sponsor: Actuated Medical, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2017

End Date

September 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Actuated Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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