What this study is
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.
What's being tested
- Bionix ShotBlocker
Intervention · DEVICE
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
Intervention · OTHER
Standard of care swaddling
- Sucrose administration
Intervention · OTHER
Standard of care sucrose administration
- Masimo Rad-97 Oximeter probe
Intervention · OTHER
Oximeter probe
Study details
- Official title
- The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
- Sponsor
- Lauren Fortier
- Conditions
- Neonatal Pain
- Enrolling
- 200 people
- Starts
- 2024-01-10
- Est. completion
- 2027-02-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 37 Weeks – 42 WeeksSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, United States
- Madeline E French, BS MBE · Contact5088870106madeline.french2@umassmed.edu
- Samia Binta Rahman, MBBS MPH · Contact6034179792samiabinta.rahman6@umassmed.edu
- Lauren Fortier, CPNP MSN · Principal investigator
- Lawrence Rhein, MD MPH · Principal investigator
- Mark Vining, MD · Sub-investigator
Recruiting
Study team
Sponsor
Lauren Fortier
Study ID STUDY00001110
Principal investigator
Lauren Fortier, CPNP, MSN
Pediatric Nurse Practitioner for the Department of Pediatrics & PICU
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.