Tan Eunicia, Braithwaite Irene, McKinlay Christopher, Riley Judith, Hoare Karen, Okesene-Gafa Karaponi, Semprini Alex, Sheridan Nicolette, Grant Cameron, Johnson David, Weatherall Mark, Asher Innes, Beasley Richard, Dalziel Stuart R
Department of Surgery, University of Auckland, Auckland, New Zealand.
Emergency Department, Middlemore Hospital, Auckland, New Zealand.
BMJ Open. 2020 Dec 10;10(12):e038296. doi: 10.1136/bmjopen-2020-038296.
Asthma is one of the most common diseases in the world and is a global public health burden. There is an urgent need for research that leads to evidenced-based primary prevention strategies to reduce the prevalence of asthma. One novel risk factor that might have a role in the pathogenesis of asthma is the use of paracetamol in early life. This trial aims to determine if paracetamol, compared with ibuprofen use, as required for fever and pain in the first year of life, increases the risk of asthma at age 6 years.
The Paracetamol and Ibuprofen in Primary Prevention of Asthma in Tamariki trial is a multicentre, open-label, two-arm parallel randomised controlled trial. 3922 infants born at ≥32 weeks' gestation will be randomly allocated to receive only paracetamol or only ibuprofen for treatment of fever and pain, if required in the first year of life. The primary outcome is asthma at 6 years of age, defined as the presence of wheeze in the preceding 12 months. Secondary outcomes include hospital admissions for bronchiolitis, wheeze or asthma in the first year of life, and within the first 6 years of life; wheeze at 3 years of age; eczema within the first year and at 3 and 6 years of age; atopy at 3 and 6 years of age.
The trial has been approved by the Northern A Health and Disability Ethics Committee of New Zealand (17/NTA/233). Dissemination plans include publication in international peer-reviewed journals, and presentation at national and international scientific meetings, assimilation into national and international guidelines, and presentation of findings to lay audiences through established media links.
ACTRN12618000303246; Pre-results.
哮喘是世界上最常见的疾病之一，是一项全球公共卫生负担。迫切需要开展研究，以得出基于证据的一级预防策略，从而降低哮喘的患病率。对乙酰氨基酚在生命早期的使用可能是哮喘发病机制中的一个新的危险因素。本试验旨在确定，与布洛芬相比，在生命的第一年根据需要用于治疗发热和疼痛的对乙酰氨基酚是否会增加6岁时患哮喘的风险。
“塔玛瑞基对乙酰氨基酚和布洛芬预防哮喘的初步研究”是一项多中心、开放标签、双臂平行随机对照试验。3922名孕龄≥32周出生的婴儿将被随机分配，在生命的第一年根据需要仅接受对乙酰氨基酚或仅接受布洛芬来治疗发热和疼痛。主要结局是6岁时的哮喘，定义为在过去12个月内出现喘息。次要结局包括在生命的第一年以及生命的前6年内因细支气管炎、喘息或哮喘住院；3岁时的喘息；1岁、3岁和6岁时的湿疹；3岁和6岁时的特应性。
该试验已获得新西兰北A健康与残疾伦理委员会批准（17/NTA/233）。传播计划包括在国际同行评审期刊上发表，在国内和国际科学会议上展示，纳入国内和国际指南，并通过既定的媒体渠道向普通受众介绍研究结果。
ACTRN12618000303246；预结果。
