Using ShotBlocker to reduce pain during Hepatitis B vaccination in newborns
Official title: The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
Run by University of Massachusetts, Worcester · NCT06624176 · Data updated 2026-11-12
This study tests if using the ShotBlocker can help reduce pain for healthy newborns getting their first Hepatitis B vaccine when combined with other comfort techniques.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 37 Weeks to 42 Weeks |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Drugs / interventions | Nirsevimab |
| Locations | 1 site (Worcester, Massachusetts) |
| Status | Recruiting |
| Started | January 10, 2024 |
| Main results expected | November 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT06624176 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy term infants born at UMass Memorial Medical Center who are under the care of the nursery team.
✕Probably not a fit
Patients who may not benefit from this study include those with congenital abnormalities, skin integrity issues, or those who have received sedatives recently.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the effectiveness of the Bionix ShotBlocker in reducing pain during the administration of the first Hepatitis B vaccine in healthy newborns. The study combines the use of ShotBlocker with established pain management techniques, such as swaddling and oral sucrose, to enhance comfort during injections. The hypothesis is that the addition of ShotBlocker will further lessen the pain response compared to standard care alone. The trial is conducted at UMass Memorial Medical Center, focusing on term infants who meet specific health criteria.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain experienced by newborns during vaccinations, improving their overall experience and comfort.
How similar studies have gone: Other studies have shown positive outcomes with similar pain management techniques in neonates, suggesting potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Lauren Fortier, CPNP, MSN — Pediatric Nurse Practitioner for the Department of Pediatrics & PICU
- Study coordinator: Madeline French, BS MBE
- Email: madeline.french2@umassmed.edu
- Phone: 5088870106
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.