AVIS - Acetaminophen Before Vaccines for Infants Study
Information source: Group Health Cooperative
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever
Intervention: Acetaminophen or placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Group Health Cooperative Official(s) and/or principal investigator(s):
Lisa A Jackson, MD, MPH, Principal Investigator, Affiliation: Group Health Cooperative
Overall contact:
Barbara A Carste, MPH, Phone: 206-287-2466, Email: carste.b@ghc.org
Summary
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.
Clinical Details
Official title: A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Primary outcome: To determine the efficacy of acetaminophen prophylaxis for prevention of post-vaccination fever (temperature 38ºC) following routine childhood immunizations.
Secondary outcome: To determine whether use of prophylactic acetaminophen reduces the infant’s medical utilization, parents’ time lost from work, and sleep lost by parents and infant within a day of vaccination.
Detailed description:
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.
Eligibility
Minimum age: 6 Weeks.
Maximum age: 9 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Child is a current Group Health enrollee.
2. Child will be seen at a Group Health clinic for a Well Child visit that is expected
to include 2 or more vaccines after 6 wks and before 10 months of age.
Exclusion Criteria:
1. If child was born at less than 36 weeks of gestation, the child is not eligible until
4 months of age or older.
2. If the child’s birth weight was less than 5. 5 pounds (2500 grams), the child is not
eligible until 4 months of age or older.
Locations and Contacts
Barbara A Carste, MPH, Phone: 206-287-2466, Email: carste.b@ghc.org
Group Health Cooperative Center for Health Studies, Seattle, Washington 98101, United States; Recruiting
Lisa A Jackson, MD, MPH, Principal Investigator
Additional Information
Starting date: May 2006
Last updated: May 11, 2006
|
