None listed
Conditions
Brief summary
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).
Interventions
Paracetamol oral suspension (120 mg/5 mL, 250 mg/5 mL):
-Child from 1 month of age
15 mg/kg/dose every 4 hours as required for fever and/or pain at discretion of parents/caregivers and /or health professionals;
Maximum of 60 mg/kg per day.
-Under 1 month of age, paracetamol may be used (15 mg/kg every 6 hours as required; maximum of 60 mg/kg per day), but ONLY under the advice of a healthcare professional.
Intervention period 12 months.
Adherence to intervention will be recorded by parents/care
Paracetamol oral suspension (120 mg/5 mL, 250 mg/5 mL): -Child from 1 month of age 15 mg/kg/dose every 4 hours as required for fever and/or pain at discretion of parents/caregivers and /or health professionals; Maximum of 60 mg/kg per day. -Under 1 month of age, paracetamol may be used (15 mg/kg every 6 hours as required; maximum of 60 mg/kg per day), but ONLY under the advice of a healthcare professional. Intervention period 12 months. Adherence to intervention will be recorded by parents/caregivers using paper-based and electronic trial diaries, and follow-up questionnaires (either telephone or electronic) at 1, 3, 6, 9 and 12 months of age.
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Birth within Auckland and Wellington regions. 2. Age <8 weeks (chronological age).
Exclusion criteria
Infants will not be enrolled if ANY of the following apply: 1. Parent is unable to give informed consent for participation in the trial; 2. Highly unlikely to remain in New Zealand for the first 6 years of life; 3. Chronic disease associated with limited life expectancy (i.e., less than 6 years); 4. Gestational age at birth <32 weeks; 5. Previous exposure to paracetamol or ibuprofen since birth.
Outcome results
None listed