The Effects of Oral Ibuprofen on Medicinal Closure of Patent Ductus Arteriosus in Full-Term Neonates in the Second Postnatal Week (original) (raw)
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International Journal of Pediatrics, 2020
Background The function of ductus arteriosus closes within a few minutes to a few days after birth in term neonates. In some cases, the duct remains open after birth, a condition which is called patent ductus arteriosus (PDA). PDA is associated with high rates of neonatal mortality and morbidity. The present study aims to evaluate the effect of oral ibuprofen on closure of PDA in term neonates. Materials and Methods In this clinical trial, 40 neonates (at the gestational age of 37 weeks and more) aged 5 to 30 days, with confirmed PDA through echocardiography, were randomly divided into two groups (n= 20). One group received ibuprofen syrup (10 mg/kg body weight) in the first 24 hours, followed by 5 mg/kg body weight for the next four days. The other group received placebo in the same manner. On the seventh day after the beginning of intervention, neonates underwent echocardiography for examination of PDA closure. Side effects of ibuprofen were evaluated. Symptoms of kidney failure, ...
High-Dose Oral Ibuprofen in Treatment of Patent Ductus Arteriosus in Full-Term Neonates
Iranian Journal of Pediatrics, 2015
Background: Patent ductus arteriosus (PDA) is an important risk for heart failure due to left to right shunt in term neonates. Objectives: In this study, we evaluated the effect of high dose ibuprofen in closure of PDA in term neonates. Patients and Methods: We used double dose ibuprofen (20 mg/kg, 10 mg/kg, and 10 mg/kg) for 3-30 day old term neonates with PDA who were admitted in the neonatal wards of Shiraz University of Medical Sciences. The results of this study were compared to the data of the previous study in our center which used the low dose of ibuprofen (10 mg/kg, 5 mg/kg, and 5 mg/kg). Results: 29 full term neonates received high-dose ibuprofen, in 18 neonates, PDA was closed after 4 days (62.1% versus 43.3% for the standard dose and 4.7% for the control group in the previous study) (P = 0.001). The results showed no significant correlation between the closure rate and gestational age, postnatal age, sex, and weight. In the 4 th day of treatment, size of the pulmonic end of ductus arteriosus decreased from 2.09 mm to 0.77 mm compared to 1.68 mm to 0.81 mm in the standard dose of oral ibuprofen and 2.1 mm to 1.4 mm in the control group (P = 0.046). Conclusions: This study indicated that high-dose oral ibuprofen was more effective in closing or decreasing the size of PDA.
Pharmacological closure of patent ductus arteriosus in pre-term infants with indomethacin has been applied since the late 1970s. However, because of complications, a search for a safer and efficacious alternative continues. In this review, we look at the available evidence in the literature for and against closure of the patent ductus arteriosus with non-steroidal anti-inflammatory medications, and we present the results of our own pilot study looking at the safety and efficacy of orally administered ibuprofen on premature infants with clinically significant patent ductus arteriosus.
2015
Background: Patent ductus arteriosus (PDA) is a common problem encountered in premature infants, especially those with respiratory distress syndrome. PDA can lead to life-threatening complications. Intravenous ibuprofen was shown to be as effective and to cause fewer side effects. If ibuprofen is effective intravenously, it will probably be effective orally too. Aim: This study was designed to determine the effectiveness and safety of oral ibuprofen compared to IV ibuprofen or no intervention for closing a PDA in preterm infants with RDS. Material and methods: A prospective study, randomized, a blind fold was conducted in NICU, at UOGH "Koco Gliozheni", Tirana, from February 2010-August 2013. The study included a total of 128 preterm infants, 28-35weeks, ≤2500gr birth weight, in the first 48-96 hours of life, with SDR and confirm the presence of DBA's (Ǿ≥1.5mm) by echocardiografic examination. Infants were treated with Ibuprofen oral, intravenous Ibuprofen, no medical ...
International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Objective: The objective of this research compares effectiveness and safety of high-dose oral ibuprofen and standard dose for treatment symptomatic PDA. Methods: A retrospective cohort study was carried out in 126 preterm infants with patent ductus arteriosus (PDA) who received oral ibuprofen and hospitalized in neonatal intensive care unit and sick newborn ward during January 2010-December 2014, preterm infants with PDA was assigned to high dose (10-10-10 mg/kg/day) oral ibuprofen group and standard dose group (10-5-5 mg/kg/day), 63 patients within in each group. Results: Baseline characteristics were no significant difference between two groups. The closure rate of the ductus arteriosus of the high dose group was significantly higher (82.5%) than in standard dose group (66.7%) (p=0.04). So, lower rate of reopen and PDA ligation. However, ductus arteriosus closure rate at discharge was not significantly different. There was no significant difference between two groups in adverse drug reaction. Conclusion: The results obtained for this study show the high dose of oral ibuprofen is more effectiveness than the standard dose for closing PDA in preterm infants without increasing the adverse drug reaction rate.
Introduction: Patent ductus arteriosus (PDA) is common in preterm neonates. Indomethacin and ibuprofen are commonly used for medical closure of patent ductus arteriosus. This study aims to evaluate the safety and efficacy of ibuprofen for treatment of PDA in very low birth weight (VLBW) infants. Methods: A retrospective audit of VLBW infants who received ibuprofen for treatment of PDA in a single centre between March 2010 and December 2014 was conducted. Infants with hemodynamically significant PDA were treated with intravenous or oral ibuprofen after echocardiographic evaluation. Response to treatment was documented with follow up echocardiography. The baseline patient characteristics, the ductal closure rate, adverse effects and need for PDA ligation were analysed. Results: Total of 138 VLBW infants received ibuprofen. 108 infants with birth weight ranging from 430-1500g received intravenous ibuprofen (group 1) and 30 infants with birth weight ranging from 661-1483g received oral Archives of Clinical and Medical Case Reports 183 ibuprofen (group 2). The closure rate of PDA was 50.9% (55/108) in-group 1 and 43.3% (13/30) in-group 2. Necrotizing enterocolitis or spontaneous intestinal perforation was observed in 11.1% (12/108) of group 1 and 10% (3/30) of group 2 infants. PDA ligation rate was 20.4% (22/108) in-group 1 and 6.7% (2/30) in-group 2. Conclusion: The closure rate of PDA following intravenous ibuprofen was 50.9% in VLBW infants. Serious gastrointestinal adverse effects occurred in 10-11% of infants treated with ibuprofen. Relatively lower closure rates and serious gastrointestinal adverse effects should be considered when treatment decisions are made for closure of PDA with ibuprofen.
European Medical, Health and Pharmaceutical Journal, 2013
Patent ductus arteriosus (PDA) is common in very premature infants. Pharmacological closure of PDA with indomethacin, a prostaglandin inhibitor, has remained the mainstay of treatment in premature infants over the last three decades. Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reaction in preterm infants. If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route.
Clinical Pharmacology & Therapeutics, 2022
Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Ibuprofen is the most frequently used drug for the treatment of patent ductus arteriosus in preterm neonates, but the exposure-response relationship between ibuprofen and closure of the ductus remains uncertain. WHAT QUESTION DID THIS STUDY ADDRESS? This study examined the effects of patient characteristics and ibuprofen exposure on the closure of the ductus arteriosus in a clinical, observational cohort. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? This study provides relevant insights into the timing of ibuprofen treatment initiation and highlights the importance of timely and adequate dosing. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE? This study provides relevant insights regarding important patient characteristics, such as postnatal-and gestational age and exposure to ibuprofen, that enhance the potential of future studies to define an exposure-response relationship.
Effect of oral Ibuprofen in ductus arteriosus closure in preterm infants
DOAJ (DOAJ: Directory of Open Access Journals), 2010
Background and Objective: Patent ductus arteriosus (PDA) is a common problem in preterm infants which can result in serious hemodynamic changes causing respiratory and cardiac morbidities if not treated in the first week of life. The treatment options available are pharmacological treatment with cyclo-oxygenase (COX) inhibitors and surgical ligation. The cyclo-oxygenase inhibitors approved for use are indomethacin and ibuprofen which have been used with different routes of administration and dosages. This study was conducted to evalute the lower and standard dose of oral ibuprofen in patent ductus arteriosus closure in preterm infants. Materials and Methods: In this clinical trial study, 44 preterm infants (<35 weeks gestational age) were randomly assigned to receive either a low dose (0.2mg/kg/dose for 3 doses, 24 hours apart) ibuprofen or a standard dose (10mg/kg/dose for the first dose, followed if needed, at 24hours interval by one or two additional doses of 5mg/kg each). These premature neonates either had clinical signs of patent ductus arteriosus or were diagnosed by echocardiography before stabilization of clinical signs. Patent ductus arteriosus closure was confirmed by echocardiography. They were under observe for drug's side effects (oliguria/anuria, GI bleeding, serum creatinin, intraventricular hemorrhage) and their clinical course was recorded. Results: The patent ductus arteriosus closure rates were the same with both doses (74% in case group vs.76% in control), 5 infants in the case group (22%) and 3 infants in the control group (14%) did not respond to the first course of therapy and needed a new course. There was a significant more rate of reducing renal output with the standard dose 33% vs. 4% (P<0.05), but the serum creatinin level was not different between two groups. One infant (4%) in the case group and 3 infants (14%) in the control group had GI bleeding. There was not any difference in intraventricular hemorrhage grading between two groups. Conclusion: This study showed that inspit of lower renal side effect, the low dose oral ibuprofen in comparison to standard dosage did not have any meaningful difference in closure of PDA in preterm infant.