BGS Neonatal Pilot Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03066895

Enrollment

Registered

2017-03-01

Start date

2017-11-06

Completion date

2020-09-01

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain From Heel Sticks

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.

Interventions

DEVICEBabyGentleStick

Experimental device.

DEVICEStandard Lancing Device

HMC standard of care.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DEVICE_FEASIBILITY

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Weeks to 42 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026