BGS Neonatal Pilot Study

Not Applicable

Completed

• Conditions: Pain From Heel Sticks
• Interventions: Device: Standard Lancing Device; Device: BabyGentleStick

• Registration Number: NCT03066895
• Lead Sponsor: Actuated Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-01
• Study Start: 2017-11-06
• Status Verified: 2020-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard Lancing Device	HMC Standard Lancing Device
Experimental	BabyGentleStick	BabyGentleStick

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 8 days	No device-attributable adverse events.

Secondary Outcome Measures

Name	Time	Method
Pain Response	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

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States