BGS Neonatal Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Pain From Heel Sticks
• Intervention / Treatment: Device: BabyGentleStick; Device: Standard Lancing Device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; BabyGentleStick	Device: BabyGentleStick; Experimental device.
ACTIVE_COMPARATOR: Standard of Care; HMC Standard Lancing Device	Device: Standard Lancing Device; HMC standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	No device-attributable adverse events.	Up to 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Response	Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale	2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure

Collaborators and Investigators

• Sponsor: Actuated Medical, Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Kim Doheny, Ph.D., The Pennsylvania State University College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2017
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00006878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No