Follow-up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two-years corrected age.

AIM: We examined the long-term outcomes and safety of early intravenous paracetamol for ductus arteriosus closure at a corrected age of two years.

METHODS: This was a follow-up of the 2013-2014 randomised, double-blind Preterm Infant's Paracetamol Study at Oulu University Hospital, Finland, which recruited 48 very preterm infants within 24 hours of birth. They received intravenous paracetamol or a placebo for four days. In 2015-2017, we followed up 44 infants (92%) at two years of corrected age. This included clinical and neurodevelopmental assessments and a parental medical history questionnaire.

RESULTS: The 44 infants (55% boys) were born at 235 -316 weeks of gestation. No differences in the cardiac parameters, including blood pressures and ultrasound scan results, were found. Neurodevelopmental stages, as quantified by the Griffiths test, were similar. No signs of autism were reported. Asthma medication was more common in the control group, but the difference was not significant. Atopy scores, numbers of infections and the use of public health services were similar between the two groups.

CONCLUSION: No long-term adverse reactions of early intravenous paracetamol were detected two years later. Larger trials are needed on the safety and efficacy of paracetamol prophylaxis for early ductal closure in very preterm infants.