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Journal of Neonatal-perinatal Medicine 2022Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several small randomized controlled trials (RCTs) and observational studies have compared high (15-20/7.5-10/7.5-10 mg/kg/dose) versus standard dose (10/5/5 mg/kg/dose) ibuprofen for patent ductus arteriosus (PDA) closure, with limited evidence on efficacy and safety.
OBJECTIVE
To systematically review and meta-analyze studies of high versus standard dose ibuprofen for the closure of PDA in preterm infants.
METHODS
Databases were searched for RCTs and observational studies assessing high compared to standard dose of ibuprofen for PDA closure for preterm infants until August 2021. The primary outcome was failure of PDA closure after the first course of ibuprofen. The secondary outcomes were the failure of PDA closure after a second course of ibuprofen, rates of PDA ligation, all-cause mortality prior to hospital discharge, bronchopulmonary dysplasia, necrotizing enterocolitis, bleeding disorders, oliguria, and serum creatinine after treatment.
RESULTS
There were 6 studies with 369 patients (3 RCT, N = 190; 3 observational studies, N = 179). Compared to standard dose, high dose ibuprofen did not significantly decrease the failure rate of PDA closure in preterm infants after the first course (Relative risk (RR) 0.74, 95% confidence interval (CI) 0.53 -1.03, 6 studies, N = 369). High dose ibuprofen significantly decreased the rates of PDA ligation compared to standard dose (RR 0.33, 95% CI 0.16 -0.70, 5 studies, N = 309).
INTERPRETATION
Based on low-grade evidence, high dose ibuprofen may more effectively reduce rates of PDA ligation compared to standard dose with no increase in adverse effects, neonatal morbidities and mortality.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature
PubMed: 35404294
DOI: 10.3233/NPM-210968 -
The Cochrane Database of Systematic... Mar 2013A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be... (Review)
Review
BACKGROUND
A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be achieved pharmacologically or by surgery. The preferred initial treatment of a symptomatic PDA, surgical ligation or treatment with indomethacin, is not clear.
OBJECTIVES
To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (indomethacin, ibuprofen or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA.
SEARCH METHODS
For this update we searched The Cochrane Library 2012, Issue 2, MEDLINE, EMBASE, CINAHL, Clinicaltrials.gov, Controlled-trials.com, Proceedings of the Annual Meetings of the Pediatric Academic Societies (2000 to 2011) (Abstracts2View(TM)) and Web of Science on 8 February 2012.
SELECTION CRITERIA
Randomised or quasi-randomised trials in preterm or low birth weight neonates with symptomatic PDA and comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA.
DATA COLLECTION AND ANALYSIS
The authors independently assessed methodological quality and extracted data for the included trial. We used RevMan 5.1 for analyses of the data.
MAIN RESULTS
One study reporting on 154 neonates was found eligible. No significant difference between surgical closure and indomethacin treatment was found for in-hospital mortality, chronic lung disease, necrotising enterocolitis, sepsis, creatinine level or intraventricular haemorrhage. There was a significant increase in the surgical group in the incidence of pneumothorax (risk ratio (RR) 2.68; 95% confidence interval (CI) 1.45 to 4.93; risk difference (RD) 0.25; 95% CI 0.11 to 0.38; number needed to treat to harm (NNTH) 4 (95% CI 3 to 9)) and retinopathy of prematurity stage III and IV (RR 3.80; 95% CI 1.12 to 12.93; RD 0.11; 95% CI 0.02 to 0.20; NNTH 9 (95% CI 5 to 50)) compared to the indomethacin group. There was a statistically significant decrease in failure of ductal closure rate in the surgical group as compared to the indomethacin group (RR 0.04; 95% CI 0.01 to 0.27; RD -0.32; 95% CI -0.43 to -0.21, number needed to treat to benefit (NNTB) 3 (95% CI 2 to 4)). No new trials were identified for inclusion in the 2012 update.
AUTHORS' CONCLUSIONS
There are insufficient data to conclude whether surgical ligation or medical treatment with indomethacin is preferred as the initial treatment for symptomatic PDA in preterm infants.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Ligation; Pneumothorax; Postoperative Complications; Randomized Controlled Trials as Topic
PubMed: 23543527
DOI: 10.1002/14651858.CD003951.pub3 -
Environmental Pollution (Barking, Essex... Jan 2019Little is known about the impacts of maternal exposure to acute episodes of outdoor air pollution, such as that resulting from wildfires, on obstetric and neonatal...
BACKGROUND
Little is known about the impacts of maternal exposure to acute episodes of outdoor air pollution, such as that resulting from wildfires, on obstetric and neonatal outcomes. This systematic review aims to synthesise the existing literature exploring the relationship between maternal exposure to short-to medium-term changes in outdoor air quality and obstetric and neonatal outcomes.
METHODS
A systematic search of peer-reviewed articles using PubMed, Cochrane Library, EMBASE, ScienceDirect, Web of Science, ProQuest, GreenFILE and Scopus was conducted in January 2018 using selected search terms. Quality of included studies were assessed using the Newcastle Ottawa Scale.
RESULTS
Eleven studies were included; eight assessed the impact of maternal exposure to air pollution exacerbation events, such as wildfires, oil well fires and volcanic eruptions, and three assessed the impact of improvement events, such as the 2018 Beijing Olympics and closure of industrial activities, on obstetric and neonatal outcomes. Studies were highly heterogenous in methodology. Six studies found a significant association between acute changes in air quality and markers of fetal growth restriction, while two did not. Three studies found an adverse association between acute changes in air quality and markers of gestational maturity, and one did not.
CONCLUSION
Overall, there is some evidence that maternal exposure to acute changes in air quality of short-to medium-term duration increases the risk of fetal growth restriction and preterm birth. The relationship for other adverse obstetric or neonatal outcomes is less clear.
Topics: Air Pollution; Beijing; Female; Fetal Growth Retardation; Fires; Humans; Industry; Infant, Newborn; Maternal Exposure; Pregnancy; Pregnancy Outcome; Premature Birth; Volcanic Eruptions
PubMed: 30469286
DOI: 10.1016/j.envpol.2018.10.086 -
Archives of Disease in Childhood. Fetal... Jan 2011To evaluate the effects of indomethacin or ibuprofen compared with placebo on closure, morbidity and mortality in preterm infants <37 weeks' gestation with... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To evaluate the effects of indomethacin or ibuprofen compared with placebo on closure, morbidity and mortality in preterm infants <37 weeks' gestation with echocardiographically and/or clinically important patent ductus arteriosus (PDA) at >24 h of life.
DATA SOURCES
MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, Cochrane Library, clinicaltrials.gov, controlled-trials.com, American Pediatric and European Paediatric Research Societies and Effective Care of the Newborn Infant.
REVIEW METHODS
Systematic review with network meta-analysis of randomised studies comparing intravenous indomethacin, ibuprofen or placebo for PDA in preterm infants at >24 h of life.
RESULTS
Ten trials compared intravenous indomethacin versus intravenous ibuprofen, nine intravenous indomethacin versus placebo and one intravenous ibuprofen versus placebo. Both intravenous indomethacin (pooled RR 2.39 (95% CI 2.05 to 2.78)) and intravenous ibuprofen (RR 2.40 (95% CI 2.03 to 2.84)) closed a PDA more effectively than placebo. Intravenous ibuprofen was associated with approximately 30% greater risk of chronic lung disease than intravenous indomethacin (RR 1.28 (95% CI 1.03 to 1.60)) or placebo (RR 1.29 (95% CI 0.99 to 1.70)). Differences in risk or benefit were not significant between any combination of intravenous indomethacin, intravenous ibuprofen or placebo groups for intraventricular haemorrhage, necrotising enterocolitis and death. Reporting on neurological outcomes was insufficient for pooling.
CONCLUSIONS
Intravenous indomethacin or ibuprofen administered to preterm infants for PDA at >24 h of life promoted ductal closure, but other short-term benefits were not seen. Treatment with intravenous ibuprofen may increase the risk of chronic lung disease. Good-quality evidence of treatment effect on morbidity, mortality and improved neurodevelopment is urgently needed.
Topics: Cardiovascular Agents; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Female; Humans; Ibuprofen; Indomethacin; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Male; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 20876595
DOI: 10.1136/adc.2009.168682 -
The Annals of Pharmacotherapy May 2006Nonsteroidal antiinflammatory drugs (NSAIDs) are increasingly being used during pregnancy to treat a variety of conditions. An evaluation of the risk of premature... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nonsteroidal antiinflammatory drugs (NSAIDs) are increasingly being used during pregnancy to treat a variety of conditions. An evaluation of the risk of premature closure of the ductus arteriosus is useful in determining the safety of NSAIDs at different stages of pregnancy.
OBJECTIVE
To determine whether NSAID use during the third trimester of pregnancy is associated with an increased risk of premature constriction of the ductus arteriosus.
METHODS
A systematic review was conducted of MEDLINE (1966-2004), Embase (1980-2004), and the Cochrane Database of Systematic Reviews (1991-2004). Summary estimates of the odds ratios, comparing ductal outcomes in exposed and unexposed fetuses, and their 95% confidence intervals were calculated assuming a random effects model.
RESULTS
Based on 217 patients exposed to indomethacin and 221 to placebo, the risk of ductal closure was 15-fold higher in the group of women exposed to NSAIDs compared with those receiving either placebo or other NSAIDs (8 studies; OR = 15.04, 95% CI 3.29 to 68.68). There was no significant increased risk of ductal closure in the infants of women treated with indomethacin compared with those receiving other drugs (4 studies; OR = 2.12, 95% CI 0.48 to 9.25). Similar results were found when calculating rate differences.
CONCLUSIONS
Short-term use of NSAIDs in late pregnancy is associated with a significant increase in the risk of premature ductal closure.
Topics: Abnormalities, Drug-Induced; Anti-Inflammatory Agents, Non-Steroidal; Ductus Arteriosus; Female; Humans; Indomethacin; Pregnancy; Pregnancy Trimester, Third; Randomized Controlled Trials as Topic; Sulindac
PubMed: 16638921
DOI: 10.1345/aph.1G428 -
Pediatric Surgery International Jul 2012The optimal timing of ostomy closure is a matter of debate. We performed a systematic review of outcomes of early ostomy closure (EC, within 8 weeks) and late ostomy... (Review)
Review
PURPOSE
The optimal timing of ostomy closure is a matter of debate. We performed a systematic review of outcomes of early ostomy closure (EC, within 8 weeks) and late ostomy closure (LC, after 8 weeks) in infants with necrotizing enterocolitis.
METHODS
PubMed, EMbase, Web-of-Science, and Cinahl were searched for studies that detailed time to ostomy closure, and time to full enteral nutrition (FEN) or complications after ostomy closure. Patients with Hirschsprung's disease or anorectal malformations were excluded. Analysis was performed using SPSS 17 and RevMan 5.
RESULTS
Of 778 retrieved articles, 5 met the inclusion criteria. The median score for study quality was 9 [range 8-14 on a scale of 0 to 32 points (Downs and Black, J Epidemiol Community Health 52:377-384, 1998)]. One study described mean time to FEN: 19.1 days after EC (n = 13) versus 7.2 days after LC (n = 24; P = 0.027). Four studies reported complication rates after ostomy closure, complications occurred in 27% of the EC group versus 23% of the LC group. The combined odds ratio (LC vs. EC) was 1.1 [95% CI 0.5, 2.5].
CONCLUSION
Evidence that supports early or late closure is scarce and the published articles are of poor quality. There is no significant difference between EC versus LC in the complication rate. This systematic review supports neither early nor late ostomy closure.
Topics: Enterocolitis, Necrotizing; Humans; Infant; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Ostomy; Postoperative Complications; Time Factors
PubMed: 22526553
DOI: 10.1007/s00383-012-3091-9 -
European Journal of Orthopaedic Surgery... Apr 2018Distal tibia physeal fractures can lead to growth complications such as premature physeal closure (PPC), angular deformity and leg length discrepancy. The aim of our... (Comparative Study)
Comparative Study Meta-Analysis Review
AIMS
Distal tibia physeal fractures can lead to growth complications such as premature physeal closure (PPC), angular deformity and leg length discrepancy. The aim of our study was to systematically review the literature to assess whether open reduction and internal fixation (ORIF) is associated with lower rates of PPC compared to closed treatment.
MATERIALS AND METHODS
We searched several databases from 1966 to 2016 for studies that evaluated ORIF versus closed treatment of distal tibia physeal fractures. We performed a meta-analysis using a random effects model to pool odds ratios (OR) for the comparison of PPC rate between children undergoing ORIF versus closed treatment. We also investigated the PPC rate in Salter-Harris (S-H) type I and II fractures. Descriptive, quantitative and qualitative data were extracted.
RESULTS
Out of the 253 articles identified, six retrospective cohort studies were eligible, with a total of 970 distal tibia physeal fractures. The pooled OR of PPC between ORIF and closed treatment showed no statistically significant difference [OR = 0.98, 95% confidence interval (CI) 0.48, 1.97; I = 49.8%, p = 0.076]. No significant difference in the rate of PPC was detected in S-H type I and II fractures with ORIF and closed treatment [OR = 1.25, 95% CI 0.72, 2.16; I = 32.1%, p = 0.22].
CONCLUSIONS
The cumulative evidence at present does not indicate an association between the method of treatment of distal tibia physeal fractures and the risk of PPC. Both treatment types are feasible, but less surgical-related complications are associated with closed treatment.
LEVEL OF EVIDENCE
III.
Topics: Adult; Child; Epidemiologic Methods; Epiphyses; Female; Fracture Fixation; Humans; Male; Tibial Fractures; Treatment Outcome
PubMed: 29052010
DOI: 10.1007/s00590-017-2062-1 -
The Bone & Joint Journal Jan 2013Fractures of the femoral neck in children are rare, high-energy injuries with high complication rates. Their treatment has become more interventional but evidence of the... (Review)
Review
Fractures of the femoral neck in children are rare, high-energy injuries with high complication rates. Their treatment has become more interventional but evidence of the efficacy of such measures is limited. We performed a systematic review of studies examining different types of treatment and their outcomes, including avascular necrosis (AVN), nonunion, coxa vara, premature physeal closure (PPC), and Ratliff's clinical criteria. A total of 30 studies were included, comprising 935 patients. Operative treatment and open reduction were associated with higher rates of AVN. Delbet types I and II fractures were most likely to undergo open reduction and internal fixation. Coxa vara was reduced in the operative group, whereas nonunion and PPC were not related to surgical intervention. Nonunion and coxa vara were unaffected by the method of reduction. Capsular decompression had no effect on AVN. Although surgery allows a more anatomical union, it is uncertain whether operative treatment or the type of reduction affects the rate of AVN, nonunion or PPC, because more severe fractures were operated upon more frequently. A delay in treatment beyond 24 hours was associated with a higher incidence of AVN.
Topics: Adolescent; Child; Femoral Neck Fractures; Fracture Fixation; Fracture Healing; Fractures, Ununited; Humans; Osteonecrosis; Postoperative Complications; Risk Factors; Treatment Outcome
PubMed: 23307688
DOI: 10.1302/0301-620X.95B1.30161 -
The Cochrane Database of Systematic... 2001Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases... (Review)
Review
BACKGROUND
Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases prostaglandin production, it could potentially help prevent indomethacin-related toxicity but also decrease ductal response to indomethacin.
OBJECTIVES
The primary objectives of this review were to assess (1) whether furosemide affects the incidence of failure of ductal closure after indomethacin and that of indomethacin-related toxicity and (2) the effect of furosemide on mid-term and long-term outcome. The secondary objective was to determine whether the effect of furosemide on renal function and water balance depends on prior extracellular volume (assessed by blood urea nitrogen [BUN]/creatinine ratio).
SEARCH STRATEGY
We searched electronic databases (Medline, Embase and Cochrane) and selected abstract books, without language restriction.
SELECTION CRITERIA
We selected studies with (1) random allocation to either indomethacin alone or indomethacin and furosemide and (2) analysis of either short-term risk-benefit ratio of furosemide, mid- or long-term outcome, or the relationship between extracellular volume at study entry and changes in renal function.
DATA COLLECTION AND ANALYSIS
We assessed studies for possible bias and for quality of assessment of ductal patency. We assessed categorical variables using relative risk and absolute risk reduction. We assessed the effects of furosemide on renal function and fluid balance by comparing changes from baseline in the treatment group with those in controls. Subsets were determined a priori based on BUN/creatinine ratio at study entry.
MAIN RESULTS
All 3 studies fulfilling the entry criteria had limitations, including possible or definite bias. There was substantial heterogeneity among studies. Furosemide administration did not significantly increase the risk of failure of ductal closure; however, sample size was insufficient to rule out even a 31% increase. In the subset with initial BUN/creatinine ratio > 20 mg/mg, 2 of 18 patients receiving furosemide could not complete a 3-dose course of indomethacin because of toxicity. Minimal or no information was available about any of the other main outcome variables. Furosemide increased urine output regardless of the initial BUN/creatinine ratio, leading to a 5% weight loss during a 3-dose course, an undesired effect in patients with initial BUN/creatinine ratio > 20 mg/mg. Furosemide increased creatinine clearance only in patients with initial BUN/creatinine ratio <20 mg/mg.
REVIEWER'S CONCLUSIONS
There is not enough evidence to support the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus. Furosemide appears to be contraindicated in the presence of dehydration in those infants.
Topics: Cyclooxygenase Inhibitors; Diuretics; Ductus Arteriosus, Patent; Furosemide; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Kidney
PubMed: 11686979
DOI: 10.1002/14651858.CD001148 -
The Cochrane Database of Systematic... 2000Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases... (Review)
Review
BACKGROUND
Inhibition of prostaglandin synthesis mediates closure of the ductus arteriosus and renal side effects after indomethacin administration. Because furosemide increases prostaglandin production, it could potentially help prevent indomethacin-related toxicity but also decrease ductal response to indomethacin.
OBJECTIVES
The primary objectives of this review were to assess (1) whether furosemide affects the incidence of failure of ductal closure after indomethacin and that of indomethacin-related toxicity and (2) the effect of furosemide on mid-term and long-term outcome. The secondary objective was to determine whether the effect of furosemide on renal function and water balance depends on prior extracellular volume (assessed by blood urea nitrogen [BUN]/creatinine ratio).
SEARCH STRATEGY
We searched electronic databases (Medline, Embase and Cochrane) and selected abstract books, without language restriction.
SELECTION CRITERIA
We selected studies with (1) random allocation to either indomethacin alone or indomethacin and furosemide and (2) analysis of either short-term risk-benefit ratio of furosemide, mid- or long-term outcome, or the relationship between extracellular volume at study entry and changes in renal function.
DATA COLLECTION AND ANALYSIS
We assessed studies for possible bias and for quality of assessment of ductal patency. We assessed categorical variables using relative risk and absolute risk reduction. We assessed the effects of furosemide on renal function and fluid balance by comparing changes from baseline in the treatment group with those in controls. Subsets were determined a priori based on BUN/creatinine ratio at study entry.
MAIN RESULTS
All 3 studies fulfilling the entry criteria had limitations, including possible or definite bias. There was substantial heterogeneity among studies. Furosemide administration did not significantly increase the risk of failure of ductal closure; however, sample size was insufficient to rule out even a 31% increase. In the subset with initial BUN/creatinine ratio > 20 mg/mg, 2 of 18 patients receiving furosemide could not complete a 3-dose course of indomethacin because of toxicity. Minimal or no information was available about any of the other main outcome variables. Furosemide increased urine output regardless of the initial BUN/creatinine ratio, leading to a 5% weight loss during a 3-dose course, an undesired effect in patients with initial BUN/creatinine ratio > 20 mg/mg. Furosemide increased creatinine clearance only in patients with initial BUN/creatinine ratio <20 mg/mg.
REVIEWER'S CONCLUSIONS
There is not enough evidence to support the administration of furosemide to premature infants treated with indomethacin for symptomatic patent ductus arteriosus. Furosemide appears to be contraindicated in the presence of dehydration in those infants.
Topics: Cyclooxygenase Inhibitors; Diuretics; Ductus Arteriosus, Patent; Furosemide; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Kidney
PubMed: 10796253
DOI: 10.1002/14651858.CD001148