Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus (original) (raw)
Related papers
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.
A multicenter, double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of intravenous (IV) ibuprofen (L-lysine) for the early closure of nonsymptomatic patent ductus arteriosus (PDA) within 72 hours of birth in extremely low-birth-weight (ELBW) infants with evidence of ductal shunting by echo-cardiogram. Eleven sites enrolled 136 infants with nonsymptomatic early PDA (gestational age < 30 weeks; body weight 500 to 1000 g) to receive a 3-day course (10 mg/kg, 5 mg/kg, and 5 mg/kg) of IV ibuprofen (n ¼ 68) or placebo (n ¼ 68). Cardiac echocardiogram was performed on study days 1 and 14, and with rescue. Infants were followed to 36 weeks postconceptional age. Patient demographics, mean (standard deviation), were similar between ibuprofen and placebo: birth weight: 798.5 g (128.7) versus 797.3 g (132.8); gestational age: 26.1 weeks (1.3) versus 26.2 weeks (1.4); and age at first dose: 1.5 days (0.7). The intent-to-treat analysis of the primary endpoint, subjects rescued, died, or dropped through study day 14, was 21/68 (30.9%) with ibuprofen and 36/68 (52.9%) for placebo (p ¼ 0.005). Death, intraventricular hemorrhage, necrotizing enterocolitis, daily fluid intake/output, liver function, bronchopulmonary dysplasia, and retinopathy of y Deceased.
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, ...
Clinical Pharmacology & Therapeutics, 2011
Our aim was to assess the hypothesis that a high-dose regimen of ibuprofen is more effective than the standarddose regimen in closing patent ductus arteriosus (PDA) without increasing adverse effects. Infants of gestational age <29 weeks, with respiratory distress syndrome (RDS) and echocardiographic evidence of significant PDA at 12-24 h of life, were randomized to receive a standard (10-5-5 mg/kg/day) or high-dose (20-10-10 mg/kg/day) course of ibuprofen. We studied 70 infants, 35 of whom received the standard dose of ibuprofen and the other 35 the high dose. Of the infants treated with the standard-dose regimen, 37% had persistent PDA as compared with 14% of those treated with the highdose regimen (P = 0.03). No differences in the occurrence of adverse effects were observed between the two groups. The high-dose ibuprofen regimen is more effective than the standard-dose regimen in closing PDA in preterm infants <29 weeks of gestation without increasing the adverse effect rate.
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.
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 ...
2019
Background: Patent Ductus Arteriosus (PDA) is a common congenital heart disease (CHD) that can lead to infant mortality. This study compared the impact of two treatment approaches (i.e. intravenous acetaminophen and ibuprofen) on the closure rate of PDA. Methods: In this randomized controlled trial, 30 infants with PDA were divided into two groups based on the applied treatment approaches (IV acetaminophen and IV ibuprofen). The two groups were compared with each other in terms of primary outcomes including post-intervention PDA grades, length of stay, duration of mechanical ventilation, and patient outcomes (i.e. death or discharge). Results: Based on the results, none of the participants had a moderate or large-sized PDA after the intervention. The post-intervention PDA closure rates in the acetaminophen and ibuprofen groups were 87.5% and 92.1%, respectively (p = 0.626). The mortality rate in the acetaminophen and ibuprofen groups were 12.5% and 14.3%, respectively (p = 0.886). I...
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.
Iranian Journal of Pediatrics, 2016
Background: The arterial ductus is a major communicative pathway which is naturally patent in the fetus, connecting the body of the major pulmonary artery to the descending aorta. Although usually closing on its own, the patent ductus arteriosus (PDA) may remain open in the second postnatal week due to a lack of prompt diagnosis in the initial days of life or an absence of prompt treatment. Objectives: To prevent the untoward sequelae of patency of the ductus arteriosus, and to avoid invasive surgery at higher ages, the researchers in the present study embarked on determining the effects of oral ibuprofen during the second postnatal week on newborns with patent ductus arteriosus. Patients and Methods: In this study, 70 neonates aged eight to 14 days, presenting at Khatam-al-Anbia clinic and the NICU ward of Shahid Sadoughi hospital in Yazd, Iran, who were diagnosed with PDA through auscultation of heart murmurs and echocardiography, were randomly assigned to two groups. The experimental group received oral ibuprofen of 10 mg/kg in day 1, 5 mg/kg in day 2, and 5 mg/kg in day 3 administered by their parents. The control group did not receive any drug. Parents were informed of the potential drug complications and side effects and asked to report them to the researchers if any occurred. Results: After intervention, the patent ductus arteriosus was closed in 62.9% of the neonates in the experimental group (35 newborns) who received oral ibuprofen, while it was closed in 54.3% of the control neonates (35 newborns) who did not receive any drug (P = 0.628). No complications were observed in either of the neonatal groups. Conclusions: Our findings showed that administration of oral ibuprofen had no significant effect on the medicinal closure of PDA in full-term neonates during the second postnatal week.