Paracetamol or Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki).

Asthma rates in New Zealand are amongst the highest in the world. Previous research has suggested that paracetamol given in the first year of life may be responsible for up to 22% of later asthma. To test this hypothesis, we propose randomising 3,922 babies to receive EITHER paracetamol or ibuprofen, as required for the treatment of fever and pain, in their first 12 months of life. We will follow participants up until the age of six years, when we will assess whether the rates of asthma between the two randomised groups are different. To assist with adherence to the study treatment, we propose prescribing the same randomised medication to all children in the household under 10 years of age over the same 12 month period. Follow up of the participants will occur in two ways; 1) Direct contact with participant's parents, by phone, or through online questionnaires at 1, 3, 6, and 9 months, and then 1, 3 years and 6 years. 2) Data retrieval from a) National datasets such as the 'National Non-­Admitted Patient Collection', the 'National Minimum Dataset', the 'Pharmaceutical Collection' and the 'National Immunisation Register'; b) Medical records; c) Institute of Environmental Science and Research (ESR) laboratory databases; d) Ministry of Health, B4 School Check data. Monitoring will also be undertaken for the children under 10 in the household who have been prescribed study medications through the national datasets (for the year of their siblings randomisation).