PILOT study - Recruitment: for a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy

None listed

The worldwide prevalence of asthma has increased in the past fifty years and there are large differences in prevalence in different countries. The reasons for this are unknown. Better understanding is very important for New Zealand which has one of the highest prevalence rates of asthma and severe asthma in children and adults in the world. There is now substantial observational evidence that paracetamol use may represent a novel risk factor both for the development of asthma and increasing its severity once established. Initially we proposed a randomised open-label parallel group trial of whether paracetamol use, as required for fever and pain, in infants following admission to hospital for bronchiolitis, increased the risk of wheeze and atopy at age 3 compared to placebo. Because paracetamol is so widely used by parents for children for a variety of indications it was difficult to know if parents/guardians will give consent to participate in a study with a 50% chance of randomisation to placebo. We did a feasibility study to determine possible comparators out of ibuprofen, restricted paracetamol (administering paracetamol only if the temperature was greater than 38.5 degrees and / or if the infant was in significant discomfort as recommended by WHO), or placebo. Of 120 infants in our feasibility study we found that Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians respectively. The feasibility raised the question of recruitment sources. We initially wanted to recruit from infants admitted with bronchiolitis. But we only enrolled 36 infants into a ‘mini-RCT’ comparing paracetamol use with restricted paracetamol use in our feaibility study. In the proposed main trial we aim to recruit 1028 participants from 3 main centres. The low recruitment rate seen in our feasibility study would mean we would require a larger number of centres and many years of recruitment to meet our target of 1028 participants. Furthermore, the findings of the study would also only be directly applicable to infants admitted with bronchiolitis and not to all infants who may receive paracetamol Therefore we now wish to explore the possible recruitment rates of all infants, and as a subset, infants whose first degree relatives have asthma, from three possible domains: 1. At ante-natal classes 2. On the post-natal wards 3. At the 6 week immunization visit at the primary healthcare providers

No related papers found yet.