An interventional study of Bionix ShotBlocker and Swaddling in Neonatal Pain, sponsored by Lauren Fortier. Recruiting at 1 site in United States. Open to participants aged 37 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Lauren Fortier · Not applicable, Interventional, and Prevention
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.
30 studies on the registry are indexed under Needlestick Injuries; 3 are open to participants now.
This study's planned enrollment of 200 is above the median of 67 across 23 interventional studies indexed under Needlestick Injuries.
Browse Needlestick Injuries studies →This is the only study on the registry with Lauren Fortier as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: Swaddling · Other: Sucrose administration · Other: Masimo Rad-97 Oximeter probe
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 · Other: Sucrose administration · Other: Masimo Rad-97 Oximeter probe
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.
Standard of care swaddling
Standard of care sucrose administration
Oximeter probe
Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
The primary outcome measure is the difference in the physiologic response before, during, and after the injection between the control and intervention groups as reflected as heart rate. Difference in heart rate will be evaluated through the measurements of heart rate recorded by a Masimo Rad-97 Oximeter.
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.
The primary outcome measure is the difference in the physiologic response before, during, and after the injection between the control and intervention groups as reflected by blood oxygen saturation. Difference in blood oxygen saturation will be evaluated through transcutaneous measurements recorded by a Masimo Rad-97 Oximeter.
Time frame: up to 4 minutes
Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
The secondary outcome measure is the difference in the pain score using the Premature Infant Pain Profile (PIPP) before, during, and after injection between the control and intervention groups. PIPP scores range from 0 to 15 and a lower score indicates a better outcome. For example, a PIPP score of 0 indicates no pain. There will be an Opt-In Video Recording option to assign a PIPP score before, during, and after vaccine administration. Infant response will be filmed during injection and evaluated by a blinded medical professional that did not participate in study procedures to assign a PIPP score.
Time frame: up to 3 minutes
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Nov 2026, 33 months after the start.
Of 12 interventional studies with no phase under Needlestick Injuries, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 0 and three quarters within 5. This study's planned 33 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Sep 2026 → Nov 2026 and completion Oct 2026 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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