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Prophylactic ibuprofen therapy of patent ductus arteriosus in preterm infants
M P De Carolis1, C Romagnoli, V Polimeni
1Department of Paediatrics, Catholic University of the Sacred Heart, Rome, Italy. iclpe@rm.unicatt.it
Insights
Ibuprofen effectively prevents patent ductus arteriosus (PDA) in very preterm infants, reducing the need for further treatment. This prophylaxis showed minimal side effects, primarily mild food intolerance, making it a promising intervention for neonates.
Area of Science:
- Neonatal medicine
- Pharmacology
- Pediatric cardiology
Background:
- Patent ductus arteriosus (PDA) is a common complication in very preterm neonates.
- Early intervention is crucial to prevent severe complications associated with PDA.
Purpose of the Study:
- To evaluate the efficacy of ibuprofen in preventing PDA in very preterm neonates.
- To identify any potential side effects of ibuprofen prophylaxis.
Main Methods:
- A randomized controlled trial involving 46 preterm neonates (gestational age < 31 weeks).
- Infants were assigned to either an ibuprofen prophylaxis group or a control group.
- Ibuprofen lysine was administered intravenously to the prophylaxis group within 2 hours of birth.
Main Results:
- 87% of neonates in the ibuprofen group did not have PDA at 72 hours, compared to 30.4% in the control group.
- Fewer neonates in the ibuprofen group required indomethacin treatment or surgical ligation.
- The main side effect observed was food intolerance.
Conclusions:
- Ibuprofen prophylaxis is effective in closing PDA and reducing the need for indomethacin treatment.
- Early administration of ibuprofen appears safe with no significant adverse effects noted in the short term.
Unlabelled:
This study was aimed at evaluating the efficacy of ibuprofen in the prophylaxis of patent ductus arteriosus (PDA) in very preterm neonates and at detecting eventual side-effects. A total of 46 preterm neonates with gestational age under 31 weeks were randomly assigned at 2 h of life: 23 to the prophylaxis group and 23 to the control group. The prophylaxis group received intravenous treatment with ibuprofen lysine (10 mg/kg), followed by 5 mg/kg after 24 h and 48 h. No placebo was given to the control group. No PDA was demonstrated at 72 h of life in 20 of the 23 babies in the ibuprofen group (87%) nor in 7 of the 23 control neonates (30.4%). All neonates with PDA received treatment with indomethacin. One neonate in the prophylaxis group and three in the control group underwent surgical ligation. Prophylaxis with ibuprofen was not associated with any significant side-effect except for food intolerance.
Conclusion:
Ibuprofen prophylaxis seems to be efficient in closing patent ductus arteriosus and in reducing indomethacin treatment. No significant early side-effects were found due to ibuprofen.