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NCT06624176 · ClinicalTrials.gov registry record · NA
ShotBlocker During Intramuscular Injection Randomized Control Trial
A NA study of Neonatal Pain, sponsored by Lauren Fortier.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06624176: Recruiting NA study of Neonatal Pain, sponsored by Lauren Fortier.
NCT06624176 is a NA study of Neonatal Pain that is actively recruiting participants, run by Lauren Fortier. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06624176, a NA study of Neonatal Pain, is actively recruiting participants, sponsored by Lauren Fortier.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Bionix ShotBlocker
- OTHER Swaddling
- OTHER Sucrose administration
- OTHER Masimo Rad-97 Oximeter probe
Study Locations (1)
Massachusetts
- UMass Memorial Medical Center- Memorial Campus - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2026-08-01 |
| Phase | NA |
What NCT06624176 shows while recruiting
NCT06624176 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Neonatal Pain appearing as the primary indexed condition, and to 4 interventions - of which Bionix ShotBlocker is the first listed.
NCT06624176 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06624176 about?
NCT06624176 is a clinical study titled "ShotBlocker During Intramuscular Injection Randomized Control Trial". 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 su...
What is the current status of trial NCT06624176?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-01-10. Estimated completion is 2026-08-01.
What conditions does trial NCT06624176 study?
This clinical trial studies the following conditions: Neonatal Pain.
What interventions are being tested in trial NCT06624176?
The interventions under investigation include: Bionix ShotBlocker (DEVICE), Swaddling (OTHER), Sucrose administration (OTHER), Masimo Rad-97 Oximeter probe (OTHER).
Who is sponsoring clinical trial NCT06624176?
This trial is sponsored by Lauren Fortier, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06624176 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06624176's enrollment target sits among peer trials
200 506th of 2000 higher than 1,435 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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