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Oral ibuprofen and ductus arteriosus closure in full-term neonates: a prospective case-control study
Hamid Amoozgar1, Mohammad Ghodstehrani, Narjes Pishva
1Department of Pediatrics, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. amozgah@sums.ac.ir
Insights
Oral ibuprofen effectively closes patent ductus arteriosus (PDA) in full-term neonates. This treatment demonstrated a significantly higher closure rate and earlier closure compared to placebo.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Pharmacology
Background:
- Patent ductus arteriosus (PDA) management in term neonates lacks consensus.
- Surgical intervention carries risks, necessitating alternative therapeutic strategies.
- Non-invasive pharmacologic options are sought for PDA closure.
Purpose of the Study:
- To evaluate the efficacy of oral ibuprofen for PDA closure in full-term neonates.
- To compare the closure rates and timing between ibuprofen treatment and placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 51 full-term neonates (>37 weeks gestational age, >3 days old).
- Exclusion criteria included ductal-dependent congenital heart disease and severe pulmonary hypertension.
- Treatment group received oral ibuprofen (10 mg/kg followed by 2x5 mg/kg doses 24h apart); control group received placebo.
Main Results:
- A statistically significant higher PDA closure rate in the ibuprofen group (73.3%) compared to the placebo group (42.9%; P = 0.029).
- Earlier closure observed in neonates treated with ibuprofen.
- Significant differences in closure days at Day 4 and Day 14 post-diagnosis between groups.
Conclusions:
- Oral ibuprofen is effective in achieving closure of PDA in full-term neonates.
- Ibuprofen facilitates earlier PDA closure compared to placebo.
- This pharmacologic approach offers a viable alternative for managing PDA in this population.
Abstract:
Management of patent ductus arteriosus (PDA) in full-term neonates remains controversial. We evaluated the effects of oral ibuprofen on PDA closure in 51 full-term neonates. All neonates were >3-days-old and had a gestational age > or = 37 weeks. Patients with ductal-dependent congenital heart disease or severe pulmonary artery hypertension (gradient >40 mmHg) were excluded. Patients were randomly assigned to the treatment group (n = 30) or the control group (n = 21). The treated group received ibuprofen suspension (initially 10 mg/kg, then two 5-mg/kg doses 24 h apart), and control neonates received a placebo. Physicians who treated the patients were blinded to group assignment. There was a statistically significant difference in the closure rate of PDA between the treated (73.3%) and control groups (42.9%, P = 0.029). Among neonates with PDA closure, there was a significant difference in the day of closure between the two groups (25.49 and 17.65% on the days 4 and 14 after diagnosis of PDA in treated neonates versus 1.96 and 15.69% in controls, respectively). This study showed the efficacy of oral ibuprofen in achieving earlier closure of PDA in full-term neonates.
