BGS Neonatal Pilot Study

Completed · Not applicable

Conditions studied: Pain From Heel Sticks

In brief

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.

Key facts

Study ID

NCT03066895

Run by

Actuated Medical, Inc.

People needed

20

Starts

2017-11-06

Expected to finish

2020-09-01

Last updated by the study team

2020-09-14

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth
• Sex: male or female

You may not qualify if…

• 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

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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