Acetaminophen Before Vaccines for Infants Study (AVIS)
11 octobre 2017 mis à jour par: Kaiser Permanente
A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
374
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98101
- Group Health Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 mois à 9 mois (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Child is a current Group Health enrollee.
- 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:
- If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Acetaminophen
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
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Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
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Comparateur placebo: Placebo
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
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Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fever >=38C Within 32 Hours of Vaccination.
Délai: Fever within 32 hours following vaccination
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Fever, defined as rectal temperature >=38C within 32 hours of vaccination.
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Fever within 32 hours following vaccination
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fever >=39C Within 32 Hours of Vaccination.
Délai: Fever within 32 hours following vaccination
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Fever, defined as rectal temperature >=39C within 32 hours of vaccination.
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Fever within 32 hours following vaccination
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Study Assignment Unblinded
Délai: At any time during participation in the study
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The need for unblinding at any time during the study
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At any time during participation in the study
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Medical Utilization
Délai: Within 32 hours of vaccination.
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Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.
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Within 32 hours of vaccination.
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Infant Fussiness
Délai: Within 32 hours of vaccination
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Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.
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Within 32 hours of vaccination
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Parent Time Lost From Sleep
Délai: On the night following vaccinations
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Parents were asked about their sleep on the night following the vaccinations.
They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.
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On the night following vaccinations
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Infant Time Lost From Sleep
Délai: On the night following vaccinations
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Parents were asked about their infant's sleep on the night following the vaccinations.
They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.
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On the night following vaccinations
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Parent Time Lost From Work
Délai: Through the day after vaccination
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Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.
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Through the day after vaccination
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Lisa A Jackson, MD, MPH, Kaiser Permanente
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2006
Achèvement primaire (Réel)
1 septembre 2009
Achèvement de l'étude (Réel)
1 septembre 2009
Dates d'inscription aux études
Première soumission
11 mai 2006
Première soumission répondant aux critères de contrôle qualité
11 mai 2006
Première publication (Estimation)
15 mai 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDC Protocol #4665
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .