Oral Ibuprofen Prophylaxis for Symptomatic Patent Ductus Arteriosus of Prematurity
Varaporn Sangtawesin MD*, Chaisit Sangtawesin MD**, Chanchai Raksasinborisut BSc***, Korbtham Sathirakul PhD***, Wiboon Kanjanapattanakul MD*, Meera Khorana MD*, Sunthorn Horpaopan MD*
Affiliation : * Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Ministry of Public Health ** Cardiology Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Ministry of Public Health *** Faculty of Pharmacy, Mahidol University
Background : The oral suspension form of ibuprofen has been shown to have the same efficacy and safety as
indomethacin in the treatment of symptomatic PDA, however its role is still questionable in the prophylaxis of
symptomatic PDA.
Objectives : 1. To assess the efficacy and safety of the drug in the prevention of symptomatic PDA in premature
infants. 2. To study its pharmacokinetics-pharmacodynamics relationship.
Materials and Methods : A randomized, single-blinded, controlled study was performed on premature neonates
with a gestational age between 28-32 weeks, birthweight < 1500 grams at the neonatal unit, Queen Sirikit
National Institute of Child Health from July 2003 to April 2004. Three doses of ibuprofen suspension or
placebo were given 24 hours apart. Clinical evaluation was performed daily until the 28th day of life.
Echocardiogram was performed prior to the drug administration, on the 3rd and 7th day of life.
Results : There were 22 and 20 cases in the ibuprofen and control group respectively. The epidemiologic data
between the groups before enrollment showed no significant differences. Prevalence of symptomatic PDA was
lower in the ibuprofen than in the control group without any significant side effects (0/22 vs 5/20, p = 0.015
on day 3 and 0/22 vs 6/20, p = 0.006 on day 7). Comparing with the pharmacokinetic study in older children
and adult, the present study revealed nearly the same Cmax but longer Tmax and T1/2 in premature neonates.
Conclusion : Oral ibuprofen suspension could reduce the prevalence of symptomatic PDA without any signifi-
cant side effects.
Keywords : Oral ibuprofen, Patent ductus arteriosus, Preterm
