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NCT04295694 · ClinicalTrials.gov registry record
Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study
A clinical trial, sponsored by CAMC Health System.
- Completed
- Registry status
- 13
- Enrollment target
NCT04295694: Completed study, sponsored by CAMC Health System.
NCT04295694 is a clinical trial that has completed, run by CAMC Health System. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04295694 has completed, sponsored by CAMC Health System.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
Study Summary
Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. PCT is being increasingly recognized as an inflammatory marker suggestive of serious bacterial infection, and is being used in clinical practice in the workup for acute febrile illness. Based on an elevated PCT level, further testing may be done, antibiotics may be started, and the patient may get admitted to the hospital for observation before identifying the cause of the elevated PCT level. The investigators believe that immunizations can cause an increase in PCT levels in the absence of an acute infection. Thus, a finding of elevated procalcitonin in a recently immunized child may not have the same clinical implication as it does in other clinical scenarios. To investigate this, the investigators designed this pilot prospective study to compare PCT levels immediately before and forty-eight hours after the administration of routine infant immunizations. The investigators will enroll healthy infants presenting for their two, four, and six-month well child visits at FamilyCare - Children's Medicine Center and receiving routine immunizations as recommended by the Centers for Disease Control.
Primary Outcome
a blood sample will be obtained from enrolled infants for PCT testing prior to their routine, scheduled immunizations. The infants will return to CMC to have their PCT levels re-tested at 2 days post immunization.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-08 |
| Est. Completion | 2017-06-21 |
What the finished NCT04295694 record still lists
NCT04295694 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04295694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04295694 about?
NCT04295694 is a clinical study titled "Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study". Fever is a well-known side effect of immunizations. When a febrile infant presents to a healthcare site, such as an emergency room, a large number of tests are usually performed, which may include a procalcitonin (PCT) level. PCT is being increasingly recognized as an inflammatory marker suggestive ...
What is the current status of trial NCT04295694?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2014-08. Estimated completion is 2017-06-21.
Who is sponsoring clinical trial NCT04295694?
This trial is sponsored by CAMC Health System, which has 28 total clinical trials registered on ClinicalTrials.gov.
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