Effect of Infant Immunization on Procalcitonin Levels - A Pilot Study
Completed
Conditions studied: Immunization
In brief
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.
Key facts
- Study ID
- NCT04295694
- Run by
- CAMC Health System
- People needed
- 13
- Starts
- 2014-08-01
- Expected to finish
- 2017-06-21
- Last updated by the study team
- 2020-03-04
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- • Infants receiving their 2,4, or 6 month well-child visit at FamilyCare-Children's Medicine Center that will include their normal, routine 2, 4, or 6 month immunizations (Prevnar®, Pediarix®, ActiHIB®, Rotateq®)
- Infant age 8 to 28 weeks old at time of study enrollment
- infant, with no acute illness (cough, congestion, fever, or decreased oral intake, …etc) in preceding fourteen days
- Infants born full term (37 weeks or more gestation)
You may not qualify if…
- • Infants born premature (born prior to 37th week of gestation)
- Having symptoms of illness in proceeding fourteen days (cough, congestion, fever, or decreased oral intake, …etc)
- Any previous hospitalizations, with exception of the hospitalization at birth
- Sick contacts in the home (contacts with symptoms of cough, congestion, or fever)
- Infants who received vaccines that are different from the standard vaccines that are administered in Children's Medicine Center, to maintain consistency of the study sample
- Infants with a chronic illness that increases their risk of infections (bronchopulmonary dysplasia, congenital heart disease, immunodeficiency…)
Where it is running
- FamilyCare HealthCenter Children's Medicine Center — Charleston, West Virginia, United States
Full record on ClinicalTrials.gov
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