BGS Neonatal Pilot Study | NCT03066895

Studies
BGS Neonatal Pilot Study

NCT03066895

Sponsor

Actuated Medical, Inc.

Status

Completed

Last Update Posted

Sep 14, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pain From Heel Sticks

Interventions

BabyGentleStick
Standard Lancing Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2017Actual

Primary Completion Date

Sep 1, 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Feb 17, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2020

Last Update Posted Date

Sep 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Actuated Medical, Inc.INDUSTRY

Collaborators

Name	Class
Milton S. Hershey Medical Center	OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	BabyGentleStick	Device: BabyGentleStick
Standard of Care	Active Comparator	HMC Standard Lancing Device	Device: Standard Lancing Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BabyGentleStick	Device	Experimental device.	Experimental
Standard Lancing Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ryan Clement, Ph.D.	Actuated Medical, Inc.	Principal Investigator
Kim Doheny, Ph.D.	The Pennsylvania State University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 5, 2023
Reset	Dec 22, 2023