University of Auckland Leads Groundbreaking Infant Pain Relief Research
New Zealand parents and healthcare providers can breathe a sigh of relief following a major study from the University of Auckland confirming that paracetamol (also known as acetaminophen) and ibuprofen are safe for use in babies during their first year of life when administered according to directions. Published today in the prestigious The Lancet Child & Adolescent Health, the Paracetamol and Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki) trial represents the largest paediatric randomized controlled trial (RCT) ever conducted in New Zealand, involving nearly 4,000 infants nationwide.
Led by Professor Stuart Dalziel, Cure Kids Chair of Child Health Research at Waipapa Taumata Rau, University of Auckland, and paediatrician at Starship Children’s Hospital, alongside co-lead author Dr. Eunicia Tan, a senior lecturer at the university and emergency physician at Middlemore Hospital, the study addresses longstanding concerns about potential links between these common painkillers and conditions like eczema or bronchiolitis—a serious lower respiratory tract infection common in infants. This research underscores the University of Auckland's pivotal role in advancing paediatric medicine through rigorous, evidence-based investigations.
Paracetamol and ibuprofen remain the most frequently prescribed or over-the-counter medications for fever and pain in infants globally, including in New Zealand. Yet, prior observational data had raised alarms, prompting this gold-standard RCT to provide definitive answers.
Historical Concerns Stemming from Observational Studies
For over a decade, observational studies have suggested a possible association between paracetamol use in infancy and increased risk of asthma, eczema, and rhinoconjunctivitis later in childhood. A seminal 2008 study in The Lancet, involving over 200,000 children across 73 countries, reported that paracetamol exposure in the first year of life was linked to higher odds of these conditions at age six to seven years (adjusted odds ratio around 1.46 for asthma). Subsequent reviews and cohort studies, including New Zealand-specific data, echoed these findings, with some estimating a doubling of asthma risk.
However, observational research is prone to confounding factors—sicker children receive more medication, potentially skewing results. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), was hypothesized as a safer alternative due to its different mechanism, inhibiting cyclooxygenase enzymes to reduce inflammation and fever more effectively. Calls grew for RCTs to disentangle correlation from causation, culminating in PIPPA Tamariki.
In New Zealand, where childhood eczema affects about 14% of children under 15 and bronchiolitis leads to thousands of hospitalizations annually, these concerns resonated deeply with families and clinicians.
Methodology of the PIPPA Tamariki Randomized Controlled Trial
PIPPA Tamariki is a multicentre, parallel-group, open-label, non-inferiority RCT designed to compare paracetamol versus ibuprofen specifically for fever or pain relief in paracetamol-naïve infants from birth. Nearly 4,000 healthy newborns were recruited across New Zealand sites, including Auckland, Wellington, and others, randomized 1:1 to receive either paracetamol (maximum daily dose 60 mg/kg) or ibuprofen (up to 30 mg/kg) exclusively when needed during the first 12 months.
- Randomization occurred at birth, ensuring unbiased allocation before any exposure.
- Parents reported symptoms via regular questionnaires on eczema (defined by UK Working Party criteria: itchy rash for at least 6 days), bronchiolitis (wheeze or crackles with respiratory distress), and asthma-like symptoms.
- Validation through pharmacy dispensing records and hospital admissions minimized recall bias.
- Adherence was high, with over 80% compliance in medication provision.
The trial, funded by the Health Research Council of New Zealand and Cure Kids, is powered to detect differences in primary outcomes at age six but reports interim one-year data. Conducted by University of Auckland and Medical Research Institute of New Zealand, it exemplifies collaborative higher education-driven research.Explore research positions at NZ universities.
Primary Results: No Increased Risk for Eczema or Bronchiolitis
At 12 months, eczema prevalence was 16% in the paracetamol group (n≈2000) versus 15% in ibuprofen (non-significant difference, p>0.05). Bronchiolitis incidence matched at approximately 5% in both arms. Adjusted analyses confirmed no association, with confidence intervals crossing 1 for odds ratios.
| Outcome | Paracetamol Group (%) | Ibuprofen Group (%) | Difference |
|---|---|---|---|
| Eczema | 16 | 15 | NS |
| Bronchiolitis | 5 | 5 | NS |
| Serious Adverse Events | Rare | Rare | None medication-related |
Serious side effects were exceedingly rare, none attributable to study drugs. These findings align with preliminary ERS Congress 2025 data.
Photo by Melany @ tuinfosalud.com on Unsplash
Understanding Paracetamol and Ibuprofen: Mechanisms, Dosing, and Differences
Paracetamol, or N-acetyl-para-aminophenol (APAP), primarily acts centrally to reduce pain and fever via cyclooxygenase inhibition in the brain, with minimal anti-inflammatory effects. Ibuprofen, a propionic acid derivative NSAID, blocks peripheral prostaglandins, offering superior fever reduction and anti-inflammatory action.
In New Zealand, per the NZ Formulary for Children:
- Paracetamol: From birth (10 mg/kg/dose 0-1m, 15 mg/kg >1m), q4-6h, max 4 doses/day.
- Ibuprofen: From 3 months (5-10 mg/kg/dose), q6-8h, avoid dehydrated infants due to renal risk.
Neither should be used prophylactically for fever alone; treat discomfort instead. Alternating is not routinely recommended.KidsHealth NZ on safe use.
Practical Implications for New Zealand Families and Clinicians
This study reassures that both medications are "incredibly safe" when dosed correctly, empowering parents to manage teething, vaccinations, or minor illnesses confidently. Paediatricians like Prof. Dalziel emphasize following labels to avoid overdose risks. In NZ's context, where bronchiolitis peaks in winter (RSV-driven), and eczema burdens 14% of kids, evidence-based relief is vital.
Healthcare providers can cite this RCT to counter misinformation. For aspiring paediatric researchers, opportunities abound at institutions like University of Auckland—check research assistant roles or NZ academic jobs.
Looking Ahead: Long-Term Follow-Up and Broader Outcomes
PIPPA Tamariki continues tracking participants to age six, targeting asthma (wheeze persisting post-3y), hay fever, and neurodevelopmental disorders like autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), diagnosable reliably at school age. "Two-thirds of wheezy 3-year-olds don't develop asthma by six," notes Dalziel.
Age-three data forthcoming will refine interim insights. This longitudinal design positions NZ universities as leaders in child health epidemiology.
Spotlight on University of Auckland's Paediatric Research Excellence
Waipapa Taumata Rau's paediatric team exemplifies higher education's impact on public health. Prof. Dalziel's portfolio includes global painkiller safety reviews, while Dr. Tan bridges emergency care and academia. Collaborations with Cure Kids and HRC NZ highlight funding ecosystems supporting uni-led trials.
For academics eyeing NZ, lecturer positions in health sciences or career advice can launch impactful careers. This study boosts UoA's global profile, attracting talent and grants.
New Zealand's Infant Health Landscape and Research Needs
NZ infants face eczema at rates mirroring global highs (14-16%), with Māori children at higher bronchiolitis risk (IRR 3.0). PIPPA Tamariki's diverse cohort reflects this, enhancing generalizability. Future research may explore equity in medication access.
University of Auckland news release | Faculty jobs in NZ.Stakeholder Perspectives and Next Steps
"These results give parents and health professionals high confidence," says Prof. Dalziel. NZ Doctor hailed it as reassuring for clinicians. Parents worldwide, via social channels, express gratitude for clarity.
Actionable: Consult GPs for dosing; monitor for allergies. Researchers: Join uni trials via postdoc opportunities. AcademicJobs.com connects talent to these vital roles.