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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

Page last updated: October 19, 2009

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