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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 37 Weeks and 42 Weeks
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.
  • Other: Swaddling
    Standard of care swaddling
  • Other: Sucrose administration
    Standard of care sucrose administration
  • Other: Masimo Rad-97 Oximeter probe
    Oximeter probe
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.
  • Other: Swaddling
    Standard of care swaddling
  • Other: Sucrose administration
    Standard of care sucrose administration
  • Other: Masimo Rad-97 Oximeter probe
    Oximeter probe

Recruiting Locations

UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts 01605
Contact:
Madeline E French, BS MBE
5088870106
madeline.french2@umassmed.edu

More Details

Status
Recruiting
Sponsor
Lauren Fortier

Study Contact

Madeline French, BS MBE
5088870106
madeline.french2@umassmed.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.