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. MATERIAL AND METHOD: A randomized, single-blinded, controlled study was performed on premature neonates with a gestational age between 28-32 weeks, birthweight < or = 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 significant side effects.
RCT Entities:
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. MATERIAL AND METHOD: A randomized, single-blinded, controlled study was performed on premature neonates with a gestational age between 28-32 weeks, birthweight < or = 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 significant side effects.
Authors: Souvik Mitra; Courtney E Gardner; Abigale MacLellan; Tim Disher; Danielle M Styranko; Marsha Campbell-Yeo; Stefan Kuhle; Bradley C Johnston; Jon Dorling Journal: Cochrane Database Syst Rev Date: 2022-04-01