Early paracetamol treatment associated with lowered risk of persistent ductus arteriosus in very preterm infants
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Published on: January 27, 2023
Outi Aikio1, Pia Härkin, Timo Saarela
1Department of Pediatrics, Oulu University Hospital , Oulu , Finland and.
Insights
Early paracetamol therapy in very preterm infants (VLGA) significantly reduced the incidence of persistent ductus arteriosus (PDA). This study suggests paracetamol may be a safe and effective treatment for PDA closure in this vulnerable population.
Area of Science:
- Neonatalogy
- Pediatric Pharmacology
- Cardiology
Background:
- Persistent ductus arteriosus (PDA) is a common complication in very preterm infants (gestation <32 weeks), delaying recovery.
- Current treatments like indomethacin, ibuprofen, and surgical ligation carry significant risks and complications.
- Paracetamol, a prostaglandin synthase inhibitor, shows potential for promoting ductus arteriosus closure.
Purpose of the Study:
- To retrospectively evaluate the association between early intravenous paracetamol therapy and the incidence of PDA in very preterm infants.
- To assess the safety profile of early paracetamol administration for PDA management.
- To compare the need for rescue ibuprofen treatment and surgical intervention between paracetamol-exposed and control groups.
Main Methods:
- A retrospective analysis was conducted on very preterm infants (VLGA) admitted between January 2008 and May 2010.
- An early intravenous paracetamol regimen (loading dose 20 mg/kg, followed by 7.5 mg/kg every 6 hours) was introduced in June 2009.
- 105 VLGA infants receiving paracetamol before 72 hours of life were compared to 88 control infants without lethal congenital diseases.
Main Results:
- The incidence of PDA significantly decreased from 30.7% in the control group to 14.7% in the paracetamol-treated group (p=0.008).
- Fewer paracetamol-exposed infants required rescue ibuprofen treatment (15 vs. 26, p=0.013) or surgical intervention (3 vs. 7).
- No detectable increase in adverse events was observed in the paracetamol-treated group.
Conclusions:
- Introduction of early intravenous paracetamol therapy was associated with a significant reduction in the annual incidence of PDA in very preterm infants.
- Paracetamol demonstrates potential efficacy and safety in promoting the early closure of the ductus arteriosus.
- Further prospective studies are warranted to definitively establish the efficacy and safety of paracetamol for PDA management.
Objectives:
Persistent ductus arteriosus (PDA) delays the recovery of very preterm infants (VLGA, gestation <32 weeks). Indomethacin/ibuprofen treatment and ligation of PDA have complications. As a prostaglandin synthase inhibitor paracetamol may also promote the closure of ductus arteriosus. We studied retrospectively whether early paracetamol therapy was associated with decreased incidence of PDA without adverse events.
Methods:
On June 2009, we introduced intravenous paracetamol during early respiratory therapy. We included 105 VLGA infants who received paracetamol before the age of 72 h. The loading dose was 20 mg/kg followed by 7.5 mg/kg every 6 hours. The 96 VLGA infants admitted from January 2008 to May 2009 without lethal congenital disease were controls. Infants dying very early were excluded, leaving 102 paracetamol-exposed and 88 controls for analysis.
Results:
After the introduction of paracetamol, the incidence of PDA decreased from 30.7% to 14.7% (p = 0.008). Ibuprofen treatment was given to 15 paracetamol-treated and to 26 control infants (p = 0.013). Three paracetamol-exposed and seven control infants required surgery. There was no detectable increase in adverse events.
Conclusions:
Annual incidence of PDA decreased after introduction of paracetamol. Efficacy and safety in promoting the early closure of ductus arteriosus remains to be established.
