BGS Neonatal Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2020-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain From Heel Sticks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

BabyGentleStick

Group Type EXPERIMENTAL

BabyGentleStick

Intervention Type DEVICE

Experimental device.

Standard of Care

HMC Standard Lancing Device

Group Type ACTIVE_COMPARATOR

Standard Lancing Device

Intervention Type DEVICE

HMC standard of care.

Interventions

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BabyGentleStick

Experimental device.

Intervention Type DEVICE

Standard Lancing Device

HMC standard of care.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

35 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes