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Sponsors and Collaborators: |
Group Health Cooperative Centers for Disease Control and Prevention |
Information provided by: | Group Health Cooperative |
ClinicalTrials.gov Identifier: | NCT00325819 |
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.
Condition | Intervention | Phase |
Fever |
Drug: Acetaminophen or placebo |
Phase IV |
MedlinePlus related topics: | Childhood Immunization Fever |
ChemIDplus related topics: | Acetaminophen |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
Official Title: | A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants |
Estimated Enrollment: | 1000 |
Study Start Date: | May 2006 |
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.
Ages Eligible for Study: | 6 Weeks to 9 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara A Carste, MPH | 206-287-2466 | carste.b@ghc.org |
United States, Washington | |||||
Group Health Cooperative Center for Health Studies | Recruiting | ||||
Seattle, Washington, United States, 98101 | |||||
Principal Investigator: Lisa A Jackson, MD, MPH |
Group Health Cooperative |
Centers for Disease Control and Prevention |
Principal Investigator: | Lisa A Jackson, MD, MPH | Group Health Cooperative |
Study ID Numbers: | CDC Protocol #4665 |
First Received: | May 11, 2006 |
Last Updated: | May 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00325819 |
Health Authority: | United States: Institutional Review Board |
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