Parent initiated oral prednisolone for acute asthma in children aged 5-11 years: randomised controlled trial

这项试验的目的是确定父母是否应该在不等待首先看医生的情况下开始使用强的松龙(一种类固醇抗炎药)来治疗他们孩子的哮喘发作。这一策略可被描述为父母启动的强的松龙治疗哮喘(PIPA)。PIPA是每个儿童哮喘治疗计划中的一个重要考虑因素，但由于缺乏研究证据，国际哮喘指南中没有明确PIPA的作用。因此，强的松龙很少在没有等待之前的医学检查的情况下开始使用。PIPA有可能通过增加在家中而不是在急诊科或医院治疗的哮喘恶化的比例来显著减少这种疾病的健康和经济负担。强的松龙已被证明是一种有效的药物，当它被给予哮喘发作的儿童时，这种哮喘发作得足够严重，以至于他们可以住院。虽然PIPA应该是一种有效的策略似乎是合乎逻辑的，但重要的是要认识到，轻度发作比严重发作要常见得多，推广PIPA作为标准做法将与强的松龙使用频率的显著增加相关。因此，重要的是要确定强的松龙在家庭环境中开始使用时是否安全有效。PIPA试验有许多独特的特点：它是以社区为基础的，绝大多数哮喘儿童都是在那里得到管理的。选择的资格标准和剂量计划是为了模拟“真实世界”的管理，临床医生和家庭将很容易解释和应用结果。将涉及非常多的儿童(308人)，这已经通过审判设置和招募方法而变得可行。此外，该议定书是根据国际研究界规定的最高标准设计的，并已提交给《柳叶刀》进行预审发表。

The objective of this trial is to determine whether parents should commence prednisolone (a steroid anti-inflammatory drug) for an asthma attack in their child without waiting to see a doctor first. This strategy could be described as parent initiated prednisolone in asthma (PIPA). PIPA is an important consideration in every child's asthma management plan, but because of a lack of research evidence the role of PIPA is not clarified in any of the international asthma guidelines. Hence prednisolone is rarely commenced without waiting for a preceding medical review. PIPA has the potential to significantly reduce the health and economic burden of the disease by increasing the proportion of asthma exacerbations managed at home rather than in the emergency department or hospital. Prednisolone has been shown to be an effective drug when it is given to children with an asthma attack that is severe enough for them to attend hospital. Whilst it would seem logical that PIPA should be an effective strategy it is important to recognise that mild attacks are far more common than severe ones, and the promotion of PIPA as standard practice would be associated with a significant increase in the frequency prednisolone administration. As such it is important to determine if prednisolone is safe and effective when commenced in the home setting. The PIPA trial has many unique features: It is community based, where the vast majority of asthmatic children are managed. The eligibility criteria and dosing schedule have been chosen to mimic 'real world' management and it will be easy for clinicians and families to interpret and apply the results. A very large number of children will be involved (308) which has been made feasible by the trial setting and recruitment methods. Furthermore the protocol has been designed in accordance with the highest standards specified by the international research community and has been submitted to 'The Lancet' for pre-trial publication.