BGS Neonatal Pilot Study

Actuated Medical

Status: Completed

Conditions: Pain From Heel Sticks

Treatments: Device: Standard Lancing Device; Device: BabyGentleStick

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03066895

STUDY00006878

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 42 weeks old

Volunteers: Accepts Healthy 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Experimental

Experimental group

Description:

BabyGentleStick

Treatment:

Device: BabyGentleStick

Standard of Care

Active Comparator group

Description:

HMC Standard Lancing Device

Treatment:

Device: Standard Lancing Device