Recruiting

ShotBlocker

Sponsor:

Lauren Fortier

Code:

NCT06624176

Conditions

Neonatal Pain

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Bionix ShotBlocker

Swaddling

Sucrose administration

Masimo Rad-97 Oximeter probe

Study Details

Brief summary:

The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.

Conditions

Neonatal Pain

Study ID

NCT06624176

Start date

Jan 10, 2024

Status verified date

Oct, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team
  • Term infants (37 to 42 weeks gestational age)
  • No acute illness that causes pain
  • Apgar score above 7 at 5 minutes
  • Have successfully attempted at least one oral feeding
  • No circumcision in the last 6 hours
  • Parental consent for Hepatitis B vaccine

Exclusion Criteria:

  • Swallow dysfunction
  • Congenital or genetic abnormalities
  • Infants who were exposed to sedatives within the last 12 hours
  • Infants with skin on thigh, hand, or foot that is not intact
  • Diagnosis of Neonatal Abstinence Syndrome (NAS)
  • Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)
  • Department of Children and Families (DCF) custody

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ShotBlocker Administration

The treatment group will employ the medical device of interest, ShotBlocker, bundled with the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

active comparator: Standard of Care Comfort Tools

The control group will employ the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

Interventions

Bionix ShotBlocker

This is a hospital-approved device used as standard-of-care in older children and adults to reduce pain during painful procedures. It is not considered established standard-of-care in the infant cohort.

Swaddling

Standard of care swaddling

Sucrose administration

Standard of care sucrose administration

Masimo Rad-97 Oximeter probe

Oximeter probe

Primary outcome measure

  • Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups. [ Time Frame: up to 4 minutes ]
  • Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups. [ Time Frame: up to 4 minutes ]

Central Contacts and Locations

Central contacts

Madeline French, BS MBE

5088870106madeline.french2@umassmed.edu

Samia Binta Rahman, MBBS MPH

6034179792samiabinta.rahman6@umassmed.edu

Locations

UMass Memorial Medical Center- Memorial Campus

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Madeline E French, BS MBE

5088870106madeline.french2@umassmed.edu

Samia Binta Rahman, MBBS MPH

6034179792samiabinta.rahman6@umassmed.edu

Principal Investigator:

Lauren Fortier, CPNP MSN

More Information

Sponsor

Lauren Fortier

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • ShotBlocker
  • Neonatal Pain
  • Needlestick

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Lauren Fortier on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.