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PeerJ 2024This systematic review and meta-analysis aims to explore the potential impact of the route of administration on the efficacy of therapies and occurrence of adverse... (Meta-Analysis)
Meta-Analysis
The impact of the route of administration on the efficacy and safety of the drug therapy for patent ductus arteriosus in premature infants: a systematic review and meta-analysis.
BACKGROUND
This systematic review and meta-analysis aims to explore the potential impact of the route of administration on the efficacy of therapies and occurrence of adverse events when administering medications to premature infants with patent ductus arteriosus (PDA).
METHOD
The protocol for this review has been registered with PROSPERO (CRD 42022324598). We searched relevant studies in PubMed, Embase, Cochrane, and the Web of Science databases from March 26, 1996, to January 31, 2022.
RESULTS
A total of six randomized controlled trials (RCTs) and five observational studies were included for analysis, involving 630 premature neonates in total. Among these infants, 480 were in the ibuprofen group (oral intravenous routes), 78 in the paracetamol group (oral intravenous routes), and 72 in the ibuprofen group (rectal oral routes). Our meta-analysis revealed a significant difference in the rate of PDA closure between the the initial course of oral ibuprofen and intravenous ibuprofen groups (relative risk (RR) = 1.27, 95% confidence interval (CI) [1.13-1.44]; < 0.0001, = 0%). In contrast, the meta-analysis of paracetamol administration via oral versus intravenous routes showed no significant difference in PDA closure rates (RR = 0.86, 95% CI [0.38-1.91]; = 0.71, = 76%). However, there was no statistically significant difference in the risk of adverse events or the need for surgical intervention among various drug administration methods after the complete course of drug therapy.
CONCLUSION
This meta-analysis evaluated the safety and effectiveness of different medication routes for treating PDA in premature infants. Our analysis results revealed that compared with intravenous administration, oral ibuprofen may offer certain advantages in closing PDA without increasing the risk of adverse events. Conversely, the use of paracetamol demonstrated no significant difference in PDA closure and the risk of adverse events between oral and intravenous administration.
Topics: Infant, Newborn; Humans; Ductus Arteriosus, Patent; Ibuprofen; Indomethacin; Cyclooxygenase Inhibitors; Infant, Low Birth Weight; Acetaminophen; Infant, Premature
PubMed: 38304184
DOI: 10.7717/peerj.16591 -
Pediatric Cardiology Jan 2017Although long-term survival is now the norm, Fontan patients face significant morbidity and premature mortality. Wide variation exists in long-term Fontan management.... (Review)
Review
Although long-term survival is now the norm, Fontan patients face significant morbidity and premature mortality. Wide variation exists in long-term Fontan management. With an aim of improving their long-term management, we conducted a systematic review to identify best available evidence and gaps in knowledge for future research focus. We also surveyed cardiologists in Australia and New Zealand managing Fontan patients, to determine the alignment of current local practice with best available evidence. A systematic review was conducted using strict search criteria (PRISMA guidelines), pertaining to long-term Fontan management. All adult congenital and paediatric cardiologists registered with The Australia and New Zealand Fontan Registry were invited to respond to an online survey. Reasonable quality evidence exists for non-inferiority of aspirin over warfarin for thromboprophylaxis in standard-risk Fontan patients. No strong evidence is currently available for the routine use of ACE inhibitors, beta blockers or pulmonary vasodilators. Little evidence exists regarding optimal arrhythmia treatment, exercise restriction/prescription, routine fenestration closure, elective Fontan conversion and screening/management of liver abnormalities. Although pregnancy is generally well tolerated, there are high rates of miscarriage and premature delivery. Thirty-nine out of 78 (50 %) cardiologists responded to the survey. Heterogeneity in response was demonstrated with regard to long-term anti-coagulation, other medication use, fenestration closure and pregnancy and contraception counselling. Substantial gaps in our knowledge remain with regard to the long-term management of Fontan patients. This is reflected in the survey of cardiologists managing these patients. We have identified a number of key areas for future research.
Topics: Adult; Australia; Child; Female; Fontan Procedure; Heart Defects, Congenital; Humans; Male; New Zealand; Postoperative Complications; Practice Patterns, Physicians'; Pregnancy; Registries; Surveys and Questionnaires; Treatment Outcome
PubMed: 27787594
DOI: 10.1007/s00246-016-1484-6 -
International Journal of Paediatric... Nov 2020Information about the functional and morphological consequences that occur following the premature loss of anterior teeth is still insufficient. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Information about the functional and morphological consequences that occur following the premature loss of anterior teeth is still insufficient.
AIM
To evaluate the consequences in children's speech and arch integrity following premature loss of primary anterior teeth compared to those without premature losses.
DESIGN
Electronic searches were performed based on the PECO criteria. Observational studies in children (P) who suffered premature loss or extraction of primary anterior teeth (E) compared to children presenting normal occlusion development (C) and the consequences to speech and dental arch perimeter (O) were included. Risk of bias and data extraction were performed. The meta-analysis evaluated the influence of premature loss of primary anterior teeth in articulatory speech disorders (distortion, omission, and substitution) and space loss in the dental arches. Random- and fixed-effect models were used, and heterogeneity was tested. The certainty of evidence was estimated using the GRADE approach.
RESULTS
From a total of 2.234 studies, six studies were included in the qualitative synthesis, and four in speech disorders meta-analysis. Despite it was not possible to perform space loss meta-analysis due to the absence of available data, qualitative analysis showed that there was no space loss after premature loss of mandibular primary incisors; a space loss, however, could be observed in children who lost primary canines at an early stage of dental development. For speech disorders results, children who lost anterior tooth presented higher chance of suffering speech distortion, than children without tooth loss (OR 5.466 [1.689, 17.692] P = .005) with low certainty of evidence. On the other hand, there were no statistically differences between premature loss of primary anterior teeth and omission (OR (a) 1.157 [0.439, 3.049] P = .767 and (OR (b) 1.393 [0.434, 4.70] P = .577) or substitution (OR (a) 1.071 [0.581, 1.974] P = .827 and OR (b) 1.218 [0.686, 2.163] P = .5), both with very low certainty of evidence.
CONCLUSIONS
Premature loss of primary anterior teeth may affect children phonation causing speech distortion. Consequences of space loss to primary dental arch still need to be further studied. Despite the speech distortion results, included articles present low-level evidence-based quality, thus new studies should be performed.
Topics: Child; Dental Arch; Humans; Incisor; Mandible; Speech; Tooth, Deciduous
PubMed: 32243000
DOI: 10.1111/ipd.12644 -
British Journal of Clinical Pharmacology Jul 2022Ibuprofen and indomethacin are the preferred drug treatment for patent ductus arteriosus (PDA) in preterm neonates. The comparative safety and efficacy of paracetamol as... (Meta-Analysis)
Meta-Analysis Review
Comparative safety and efficacy of paracetamol versus non-steroidal anti-inflammatory agents in neonates with patent ductus arteriosus: A systematic review and meta-analysis of randomized controlled trials.
AIM
Ibuprofen and indomethacin are the preferred drug treatment for patent ductus arteriosus (PDA) in preterm neonates. The comparative safety and efficacy of paracetamol as an alternative has not yet been well established. The aim of our study was to define the comparative efficacy and safety of paracetamol versus ibuprofen and indomethacin for PDA.
METHODS
We performed a systematic literature search in PubMed, Scopus and Cochrane databases on randomized controlled trials comparing the efficacy and/or the safety of paracetamol versus ibuprofen and/or indomethacin and meta-analysed the available data.
RESULTS
There were 1718 neonates from 20 eligible studies. Paracetamol did not differ from ibuprofen or indomethacin regarding the primary (odds ratio [OR]: 0.93; 95% confidence interval [CI]: 0.69-1.26, P-value: 0.650, when compared to ibuprofen, and OR: 0.78; 95% CI: 0.20-3.02, P-value: 0.716, when compared to indomethacin) and overall (OR: 1.17; 95% CI: 0.82-1.66, P-value: 0.394, when compared to ibuprofen, and OR: 1.12; 95% CI: 0.58-2.15, P-value: 0.733, when compared to indomethacin) PDA closure rates. Paracetamol resulted in significantly reduced risk of oliguria and a tendency towards less gastrointestinal bleeding.
CONCLUSION
There was no significant difference between paracetamol and ibuprofen or indomethacin in the PDA closure rates. However, paracetamol caused fewer adverse effects.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Randomized Controlled Trials as Topic
PubMed: 35203104
DOI: 10.1111/bcp.15291 -
European Journal of Pediatrics Mar 2021Patent ductus arteriosus (PDA), one of the most common disorders in newborns, is associated with many complications in premature infants such as respiratory distress... (Meta-Analysis)
Meta-Analysis Review
Patent ductus arteriosus (PDA), one of the most common disorders in newborns, is associated with many complications in premature infants such as respiratory distress syndrome (RDS) and bronchopulmonary dysplasia (BPD). However, the diagnosis of hemodynamically significant patent ductus arteriosus (hsPDA) is still an ongoing debate. The relationship between platelet parameters and hsPDA has been explored in many studies over the last decade, but there is still no definite conclusion. We aim to explain the relationship between platelet parameters and hsPDA through this meta-analysis. Therefore, we used PubMed, Embase, the Cochrane Library, and Web of Science databases as well as the Google Scholar to search for studies up to May 2020. Three reviewers independently screened the articles, evaluated the quality of the articles, and collected the data. The random-effects model and fixed-effects model were used to evaluate pooled results. We used the I-square (I) test to examine heterogeneity and the funnel plot; Egger's test and meta-regression analysis were used to test for publication bias. Influence analysis was also carried out in this study. Stata version 12.0 software was used for data analysis. Fourteen studies, which included 3330 newborns, were extracted from 986 studies. The weighted mean difference (WMD) of the platelet count was - 17.98 (p < 0.001), the platelet distribution width (PDW) was 0.27 (p = 0.266), the mean platelet volume (MPV) was 0.01 (p = 0.958), the plateletcrit (PCT) was - 0.03 (p < 0.001), and the platelet mass was - 150.10 (p = 0.001).Conclusion: Platelet count, PCT, and platelet mass of the first 3 days of life are potentially helpful in identifying premature infants at risk of hsPDA. More prospective studies on the relationship between different degrees of thrombocytopenia and platelet function and hsPDA should be conducted. What is Known: • Platelets are involved in the formation of thrombi during closure of the arterial duct. • The diagnosis of hsPDA by Doppler echocardiography and clinical signs is not precise enough. What is New: • Preterm newborns with hsPDA in the first week of life demonstrated a significant reduction in platelet count, platelet mass, and plateletcrit in the first 3 days of life. • No significant difference was shown between hsPDA and non-hsPDA infants in platelet distribution width and mean platelet volume in the first 3 days of life.
Topics: Ductus Arteriosus, Patent; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Prospective Studies; Respiratory Distress Syndrome, Newborn
PubMed: 32949292
DOI: 10.1007/s00431-020-03802-5 -
Clinical Neurology and Neurosurgery Jul 2024Craniosynostosis, a developmental craniofacial anomaly, can impair brain development and cause abnormal skull shape due to premature closure of one or more cranial... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Craniosynostosis, a developmental craniofacial anomaly, can impair brain development and cause abnormal skull shape due to premature closure of one or more cranial sutures. Traditional surgical treatments have evolved from open operations to minimally invasive endoscopic techniques. This systematic review and meta-analysis aim to evaluate the effectiveness and safety of the endoscopic approach in craniosynostosis correction.
METHODS
Adhering to Cochrane Group standards and the PRISMA framework, this review utilized databases like PubMed, Embase, and Web of Science, focusing on clinical and surgical outcomes of endoscopic craniosynostosis operations up to December 2023. Inclusion criteria emphasized studies with at least five patients undergoing endoscopic procedures, while exclusion criteria involved non-English papers, incomplete texts, and overlapping data. Statistical analysis used R software with various packages, and methodological bias was assessed using the ROBINS-I framework.
RESULTS
The review included 30 studies (4 prospective, 26 retrospective) with 2561 patients. The median age at operation was 3.20 months. Findings showed a mean operative time of 68.06 min, median hospital stay of 1.28 days, and mean blood loss of 29.89 ml. Blood transfusion was required in 9.97% of cases. Helmet therapy post-operation was common, with a median duration of 9 months. The rate of postoperative complications was 1.86%, and the reoperation rate was 3.07%. No procedure-related mortality was observed. The study noted substantial variations in the handling of craniosynostosis and a lack of consensus on the optimal timing and surgical approach.
CONCLUSION
Endoscopic techniques for craniosynostosis repair demonstrate safety and effectiveness, characterized by low complication risks and favorable surgical outcomes. However, due to the limitations of observational studies and inherent heterogeneity, further comprehensive and controlled trials are needed to validate these findings and understand the long-term outcomes of the endoscopic approach.
Topics: Craniosynostoses; Humans; Neuroendoscopy; Treatment Outcome; Postoperative Complications; Endoscopy; Infant; Operative Time; Length of Stay
PubMed: 38749357
DOI: 10.1016/j.clineuro.2024.108296 -
Orthopaedic Journal of Sports Medicine Jul 2019Given the proximity of the medial patellofemoral ligament (MPFL) femoral insertion to the distal femoral physis in skeletally immature patients, multiple techniques for... (Review)
Review
BACKGROUND
Given the proximity of the medial patellofemoral ligament (MPFL) femoral insertion to the distal femoral physis in skeletally immature patients, multiple techniques for femoral graft fixation have been described.
PURPOSE
To systematically review the literature and evaluate outcomes and complications following MPFL reconstruction in skeletally immature patients.
STUDY DESIGN
Systematic review; Level of evidence, 4.
METHODS
A comprehensive literature search was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines through use of the PubMed, Embase, and Cochrane Central databases. All original, English-language studies reporting outcomes or complications following MPFL reconstruction in skeletally immature patients were included. Skeletally mature patients were excluded. Data regarding demographics, surgical technique, graft type, outcomes, and complications were recorded. Study quality was assessed by use of the modified Coleman methodology score. Statistical analysis was performed through use of chi-square and weighted mean pooled cohort statistics, where appropriate, with significance set at < .05.
RESULTS
7 studies that entailed 132 MPFL reconstructions (126 patients) met the inclusion criteria. Females comprised 57.9% of the cohort (73 females), and the mean age was 13.2 years (range, 6-17 years). Mean postoperative follow-up was 4.8 years (range, 1.4-10 years). All of the grafts used were autograft, with gracilis tendon (n = 80; 60.6%) being the most common. Methods of femoral fixation included interference screw (n = 52; 39.4%), suture anchor (n = 51; 38.6%), and soft tissue pulley around the medial collateral ligament or adductor tendon (n = 29; 21.9%). Pooled Kujala scores improved from 59.1 to 84.6 after MPFL reconstruction. The total reported complication rate was 25.0% (n = 33) and included 5 redislocations (3.8%) and 15 subluxation events (11.4%). No cases of premature physeal closure were noted, and there were 3 reports of donor site pain (2.3%). Neither autograft choice ( > .804) nor method of femoral fixation ( > .416) influenced recurrent instability or overall complication rates.
CONCLUSION
These findings suggest that MPFL reconstruction in skeletally immature patients is a viable treatment option, with significant improvement in patient-reported outcomes and redislocation event rates of less than 5% at nearly 5-year follow-up. Further high-quality research is needed to determine optimal graft options and surgical technique while considering recurrent instability, donor site morbidity, and potential injury to the adjacent physis.
PubMed: 31384615
DOI: 10.1177/2325967119855023 -
Current Pediatric Reviews 2016Patent ductus arteriosus (PDA) is a common factor complicating the care of the preterm infant, but controversy remains regarding the long term effects of PDA and... (Review)
Review
BACKGROUND
Patent ductus arteriosus (PDA) is a common factor complicating the care of the preterm infant, but controversy remains regarding the long term effects of PDA and iatrogenic closure of PDA.
METHODS
Studies presenting data relevant to the relationship between PDA and mortality and morbidity were identified via a systematic literature review. These studies were classified based on PDA exposure in the case and control groups. The data was abstracted and summarized using linear modeling, resulting in summary estimates of mean effect size (odds ratio).
RESULTS
Recently published data suggests that a significant relationship between PDA and mortality, bronchopulmonary dysplasia/chronic lung disease, necrotizing enterocolitis, or retinopathy of prematurity is unlikely. However, the data related to mortality leaves room for some debate. Quantitative analysis of the data shows that PDA is a risk factor for intraventricular hemorrhage and related studies suggest this risk may carry over into long term neurological outcomes.
CONCLUSION
Further efforts to better understand the physiologic consequences of PDA and its closure in preterm infants is necessary. A focus on new biochemical or physiologic factors that mediate or confound any apparent effect of PDA and are themselves amenable to targeted therapy is imperative to further progress in improving the outcomes of these patients.
Topics: Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Humans; Infant, Extremely Low Birth Weight; Infant, Extremely Premature; Infant, Newborn; Ligation; Lung Diseases; Morbidity; Neurodevelopmental Disorders; Retinopathy of Prematurity; Risk Factors
PubMed: 27197950
DOI: 10.2174/157339631202160506001621 -
Paediatrics & Child Health Aug 2023Acetaminophen has gained interest in the neonatal community for its use in the management of hemodynamically significant patent ductus arteriosus (HsPDA) in preterm...
OBJECTIVES
Acetaminophen has gained interest in the neonatal community for its use in the management of hemodynamically significant patent ductus arteriosus (HsPDA) in preterm infants. We conducted a systematic review of randomized controlled trials (RCTs) comparing the efficacy and safety of acetaminophen with indomethacin for the management of HsPDA in preterm infants.
METHODS
We searched PROSPERO, OVID Medline, OVID EMBASE, Wiley Cochrane Library (CDSR and Central), EBSCO CINAHL, and SCOPUS from inception to June 15, 2021. Bibliographies of identified studies were searched for additional references. Data were analyzed with Review Manager (RevMan) Version 5.3.
RESULTS
Four RCTs were identified, enrolling a total of 380 subjects. There was no difference between the interventions for the outcome of PDA closure after one course (RR 1.04 [95% CIs: 0.84, 1.29], -value 0.70) or after two courses of treatment (RR 1.01 [95% CIs: 0.92, 1.12], -value 0.77); and for the outcome of PDA ligation (RR 1.56 [95% CIs: 0.48, 5.12], -value 0.46). However, patients who received acetaminophen had lower rates of necrotizing enterocolitis (RR 0.37 [95% CIs: 0.14, 0.95], -value 0.04). There were no significant differences noted in the other clinical outcomes, that is, intraventricular hemorrhage, bronchopulmonary dysplasia, retinopathy of prematurity requiring treatment, and death. Two studies noted significant post-treatment elevation of serum creatinine and blood urea with indomethacin, as compared to none with acetaminophen use.
CONCLUSIONS
Acetaminophen has comparable efficacy to indomethacin for the outcome of HsPDA closure, with a better safety profile, that is, lesser rates of necrotizing enterocolitis and post-treatment azotemia noted with its use.
PubMed: 37484043
DOI: 10.1093/pch/pxac130 -
Archives of Disease in Childhood. Fetal... Mar 2016We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus arteriosus (PDA) in neonates, and to explore the effects of clinical variables on the risk of closure.
DATA SOURCE
MEDLINE, Scopus and ISI Web of Knowledge databases, using the following medical subject headings and terms: paracetamol, acetaminophen and patent ductus arteriosus. Electronic and manual screening of conference abstracts from international meetings of relevant organisations. Manual search of the reference lists of all eligible articles.
STUDY SELECTION
Studies comparing paracetamol versus ibuprofen, indomethacin, placebo or no intervention for the treatment of PDA.
DATA EXTRACTION
Data regarding efficacy and safety were collected and analysed.
RESULTS
Sixteen studies were included: 2 randomised controlled trials (RCTs) and 14 uncontrolled studies. Quality of selected studies is poor. A meta-analysis of RCTs does not demonstrate any difference in the risk of ductal closure (Mantel-Haenszel model, RR 1.07, 95% CI 0.87 to 1.33 and RR 1.03, 95% CI 0.92 to 1.16, after 3 and 6 days of treatment, respectively). Proportion meta-analysis of uncontrolled studies demonstrates a pooled ductal closure rate of 49% (95% CI 29% to 69%) and 76% (95% CI 61% to 88%) after 3 and 6 days of treatment with paracetamol, respectively. Safety profiles of paracetamol and ibuprofen are similar.
CONCLUSIONS
Efficacy and safety of paracetamol appear to be comparable with those of ibuprofen. These results should be interpreted with caution, taking into account the non-optimal quality of the studies analysed and the limited number of neonates treated with paracetamol so far.
Topics: Acetaminophen; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Infant, Newborn; Infant, Premature
PubMed: 26283668
DOI: 10.1136/archdischild-2014-307312