-
Frontiers in Pediatrics 2019Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative...
Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative choice when these drugs are ineffective or contraindicated. This study aimed to confirm paracetamol's efficacy and safety compared with those of other drugs or placebos for patent ductus arteriosus closure in premature infants. We conducted a literature search using the Cochrane Library, PubMed, CINAHL, and EMBASE databases for randomized controlled trials and quasi-randomized controlled trials. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to direct the process and PICO (P, population; I, intervention/interest; C, comparator; O, outcome) principle to constitute the theme. We combined the research data through qualitative summaries or meta-analyses. The final analyses included 15 trials ( = 1,313). No significant differences were noted between paracetamol and ibuprofen except for shorter mean days needed for patent ductus arteriosus closure, lower risk of gastrointestinal bleeding, and hyperbilirubinemia. No significant difference existed between paracetamol and indomethacin. Oral paracetamol was more effective than placebo in infants weighing 1,501-2,500 g. Our study findings tentatively conclude that paracetamol can induce early patent ductus arteriosus closure without significant side effects but that its efficacy is not superior to that of indomethacin.
PubMed: 32133328
DOI: 10.3389/fped.2019.00568 -
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 -
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 -
Frontiers in Pediatrics 2023Endotypes leading to very and extremely preterm birth are clustered into two groups: infection/inflammation and dysfunctional placentation. We conducted a systematic...
INTRODUCTION
Endotypes leading to very and extremely preterm birth are clustered into two groups: infection/inflammation and dysfunctional placentation. We conducted a systematic review of observational studies exploring the association between these two endotypes and the pharmacological closure of patent ductus arteriosus (PDA) induced by cyclooxygenase (COX) inhibitors. Chorioamnionitis represented the infectious-inflammatory endotype, while dysfunctional placentation proxies were hypertensive disorders of pregnancy (HDP) and small for gestational age (SGA) or intrauterine growth restriction.
METHODS
PubMed/Medline and Embase databases were searched. The random-effects odds ratio (OR) and 95% confidence interval (CI) were calculated for each association. We included 30 studies (12,639 infants).
RESULTS
Meta-analysis showed a significant association between exposure to HDP and increased rate of pharmacological closure of PDA (17 studies, OR 1.41, 95% CI 1.10-1.81, p = 0.006). In contrast, neither chorioamnionitis (13 studies, OR 0.75, 95% CI 0.47-1.18, = 0.211) nor SGA (17 studies, OR 1.20, 95% CI 0.96-1.50, = 0.115) were significantly associated with the response to therapy. Subgroup analyses showed that the higher response to COX inhibitors in the HDP group was significant for indomethacin (OR 1.568, 95% CI 1.147-2.141, = 0.005) but not for ibuprofen (OR 1.107, 95% CI 0.248-4.392, = 0.894) or for the studies using both drugs (OR 1.280, 95% CI 0.935-1.751, = 0.124). However, meta-regression showed that this difference between the drugs was not statistically significant ( = 0.404).
DISCUSSION/CONCLUSION
Our data suggest that the pathologic condition that triggers prematurity may alter the response to pharmacological treatment of PDA. The DA of infants exposed to HDP appears to be more responsive to COX inhibitors.
PubMed: 36937978
DOI: 10.3389/fped.2023.1078506 -
Indian Heart Journal 2020This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent ductus arteriosus (PDA) in preterm infants.
METHODS
We performed a systematic literature search on topics that assesses the use of oral paracetamol compared to oral ibuprofen in preterm neonates diagnosed with PDA from PubMed, EuropePMC, Cochrane Central Database, ScienceDirect, ProQuest, ClinicalTrials.gov, and hand-sampling from potential articles.
RESULTS
There were 1547 subjects from 10 selected studies. Primary closure rate was similar in both groups. Subgroup analysis on studies enrolling neonates with ≤30 weeks gestational age showed that ibuprofen was superior (OR 0.52 [0.31, 0.90], I: 0%). On the other hand, paracetamol was superior neonates with ≤34 weeks gestational age (OR 1.73 [1.01, 2.94], I: 30%). Reopening rate, surgical closure rate, mortality, intraventricular hemorrhage, and necrotizing enterocolitis were similar in both groups. Rate of renal dysfunction (OR 0.27 [0.10, 0.77], I: 0%) and gastrointestinal bleeding (OR 0.31 [0.11, 0.88], I: 0%) were lower in paracetamol group. Subgroup analysis of randomized controlled studies (RCTs) showed similar results. Meta-regression analysis showed that the primary closure rate was not influenced by gestational age, birth weight, and gender. GRADE demonstrates a low level of certainty for primary closure and mortality. Renal dysfunction and gastrointestinal bleeding havea moderate level of certainty.
CONCLUSION
There was no significant difference between the efficacy of oral paracetamol and oral ibuprofen. However, the rate of renal dysfunction and gastrointestinal bleeding were higher in oral ibuprofen.
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Cardiac Surgical Procedures; Ductus Arteriosus, Patent; Gestational Age; Humans; Ibuprofen; Infant, Newborn; Infant, Premature; Treatment Outcome
PubMed: 32768013
DOI: 10.1016/j.ihj.2020.05.012 -
British Journal of Cancer Jul 2014Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The... (Meta-Analysis)
Meta-Analysis Review
Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: systematic review and meta-analyses of published and unpublished data.
BACKGROUND
Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The impact of ESAs on quality of life (QoL) is controversial and led to different recommendations of medical societies and authorities in the USA and Europe. We aimed to critically evaluate and quantify the effects of ESAs on QoL in cancer patients.
METHODS
We included data from randomised controlled trials (RCTs) on the effects of ESAs on QoL in cancer patients. Randomised controlled trials were identified by searching electronic data bases and other sources up to January 2011. To reduce publication and outcome reporting biases, we included unreported results from clinical study reports. We conducted meta-analyses on fatigue- and anaemia-related symptoms measured with the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) and FACT-Anaemia (FACT-An) subscales (primary outcomes) or other validated instruments.
RESULTS
We identified 58 eligible RCTs. Clinical study reports were available for 27% (4 out of 15) of the investigator-initiated trials and 95% (41 out of 43) of the industry-initiated trials. We excluded 21 RTCs as we could not use their QoL data for meta-analyses, either because of incomplete reporting (17 RCTs) or because of premature closure of the trial (4 RCTs). We included 37 RCTs with 10581 patients; 21 RCTs were placebo controlled. Chemotherapy was given in 27 of the 37 RCTs. The median baseline haemoglobin (Hb) level was 10.1 g dl(-1); in 8 studies ESAs were stopped at Hb levels below 13 g dl(-1) and in 27 above 13 g dl(-1). For FACT-F, the mean difference (MD) was 2.41 (95% confidence interval (95% CI) 1.39-3.43; P<0.0001; 23 studies, n=6108) in all cancer patients and 2.81 (95% CI 1.73-3.90; P<0.0001; 19 RCTs, n=4697) in patients receiving chemotherapy, which was below the threshold (≥ 3) for a clinically important difference (CID). Erythropoiesis-stimulating agents had a positive effect on anaemia-related symptoms (MD 4.09; 95% CI 2.37-5.80; P=0.001; 14 studies, n=2765) in all cancer patients and 4.50 (95% CI 2.55-6.45; P<0.0001; 11 RCTs, n=2436) in patients receiving chemotherapy, which was above the threshold (≥ 4) for a CID. Of note, this effect persisted when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy. There was some evidence that the MDs for FACT-F were above the threshold for a CID in RCTs including cancer patients receiving chemotherapy with Hb levels below 12 g dl(-1) at baseline and in RCTs stopping ESAs at Hb levels above 13 g dl(-1). However, these findings for FACT-F were not confirmed when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy.
CONCLUSIONS
In cancer patients, particularly those receiving chemotherapy, we found that ESAs provide a small but clinically important improvement in anaemia-related symptoms (FACT-An). For fatigue-related symptoms (FACT-F), the overall effect did not reach the threshold for a CID.
Topics: Anemia; Erythropoiesis; Fatigue; Hematinics; Humans; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 24743705
DOI: 10.1038/bjc.2014.171 -
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 -
JAMA Network Open Mar 2024Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
IMPORTANCE
Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
OBJECTIVE
To determine the characteristics, progression, and output of randomized platform trials.
EVIDENCE REVIEW
In this systematic review of randomized platform trials, Medline, Embase, Scopus, trial registries, gray literature, and preprint servers were searched, and citation tracking was performed in July 2022. Investigators were contacted in February 2023 to confirm data accuracy and to provide updated information on the status of platform trial arms. Randomized platform trials were eligible if they explicitly planned to add or drop arms. Data were extracted in duplicate from protocols, publications, websites, and registry entries. For each platform trial, design features such as the use of a common control arm, use of nonconcurrent control data, statistical framework, adjustment for multiplicity, and use of additional adaptive design features were collected. Progression and output of each platform trial were determined by the recruitment status of individual arms, the number of arms added or dropped, and the availability of results for each intervention arm.
FINDINGS
The search identified 127 randomized platform trials with a total of 823 arms; most trials were conducted in the field of oncology (57 [44.9%]) and COVID-19 (45 [35.4%]). After a more than twofold increase in the initiation of new platform trials at the beginning of the COVID-19 pandemic, the number of platform trials has since declined. Platform trial features were often not reported (not reported: nonconcurrent control, 61 of 127 [48.0%]; multiplicity adjustment for arms, 98 of 127 [77.2%]; statistical framework, 37 of 127 [29.1%]). Adaptive design features were only used by half the studies (63 of 127 [49.6%]). Results were available for 65.2% of closed arms (230 of 353). Premature closure of platform trial arms due to recruitment problems was infrequent (5 of 353 [1.4%]).
CONCLUSIONS AND RELEVANCE
This systematic review found that platform trials were initiated most frequently during the COVID-19 pandemic and declined thereafter. The reporting of platform features and the availability of results were insufficient. Premature arm closure for poor recruitment was rare.
Topics: Humans; Pandemics; COVID-19; Cognition; Data Accuracy; Medical Oncology
PubMed: 38506807
DOI: 10.1001/jamanetworkopen.2024.3109 -
The Cochrane Database of Systematic... Apr 2018In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can be treated surgically; or medically with one of two prostaglandin inhibitors, indomethacin or ibuprofen. Case reports suggest that paracetamol may be an alternative for the closure of a PDA. An association between prenatal or postnatal exposure to paracetamol and later development of autism or autism spectrum disorder has been reported.
OBJECTIVES
To determine the effectiveness and safety of intravenous or oral paracetamol compared with placebo or no intervention, intravenous indomethacin, intravenous or oral ibuprofen, or with other cyclo-oxygenase inhibitors for treatment of an echocardiographically diagnosed PDA in preterm or low birth weight infants.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 10), MEDLINE via PubMed (1966 to 6 November 2017), Embase (1980 to 6 November 2017), and CINAHL (1982 to 6 November 2017). We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCT) and quasi-randomised trials.
SELECTION CRITERIA
We included RCTs in which paracetamol was compared to no intervention, placebo or other agents used for closure of PDA irrespective of dose, duration and mode of administration in preterm (≤ 34 weeks' postmenstrual age) infants. We both reviewed the search results and made a final selection of potentially eligible articles by discussion. We included studies of both prophylactic and therapeutic use of paracetamol.
DATA COLLECTION AND ANALYSIS
We performed data collection and analyses in accordance with the methods of the Cochrane Neonatal Review Group. We used the GRADE approach to assess the quality of evidence for the following outcomes when data were available: failure of ductal closure after the first course of treatment; neurodevelopmental impairment; all-cause mortality during initial hospital stay (death); gastrointestinal bleed or stools positive for occult blood; and serum levels of creatinine after treatment (µmol/L).
MAIN RESULTS
We included eight studies that reported on 916 infants. One of these studies compared paracetamol to both ibuprofen and indomethacin. Five studies compared treatment of PDA with paracetamol versus ibuprofen and enrolled 559 infants. There was no significant difference between paracetamol and ibuprofen for failure of ductal closure after the first course of drug administration (typical risk ratio (RR) 0.95, 95% confidence interval (CI) 0.75 to 1.21; typical risk difference (RD) -0.02, 95% CI -0.09 to 0.09); I² = 0% for RR and RD; moderate quality of evidence. Four studies (n = 537) reported on gastrointestinal bleed which was lower in the paracetamol group versus the ibuprofen group (typical RR 0.28, 95% CI 0.12 to 0.69; typical RD -0.06, 95% CI -0.09 to -0.02); I² = 0% for RR and RD; number needed to treat for an additional beneficial outcome (NNTB) 17 (95% CI 11 to 50); moderate quality of evidence. The serum levels of creatinine were lower in the paracetamol group compared with the ibuprofen group in four studies (moderate quality of evidence), as were serum bilirubin levels following treatment in two studies (n = 290). Platelet counts and daily urine output were higher in the paracetamol group compared with the ibuprofen group. One study reported on long-term follow-up to 18 to 24 months of age following treatment with paracetamol versus ibuprofen. There were no significant differences in the neurological outcomes at 18 to 24 months (n = 61); (low quality of evidence).Two studies compared prophylactic administration of paracetamol for a PDA with placebo or no intervention in 80 infants. Paracetamol resulted in a lower rate of failure of ductal closure after 4 to 5 days of treatment compared to placebo or no intervention which was of borderline significance for typical RR 0.49 (95% CI 0.24 to 1.00; P = 0.05); but significant for typical RD -0.21 (95% CI -0.41 to -0.02); I² = 0 % for RR and RD; NNTB 5 (95% CI 2 to 50); (low quality of evidence).Two studies (n = 277) compared paracetamol with indomethacin. There was no significant difference in the failure to close a PDA (typical RR 0.96, 95% CI 0.55 to 1.65; I² = 11%; typical RD -0.01, 95% CI -0.09 to 0.08; I² = 17%) (low quality of evidence). Serum creatinine levels were significantly lower in the paracetamol group compared with the indomethacin group and platelet counts and daily urine output were significantly higher in the paracetamol group.
AUTHORS' CONCLUSIONS
Moderate-quality evidence according to GRADE suggests that paracetamol is as effective as ibuprofen; low-quality evidence suggests paracetamol to be more effective than placebo or no intervention; and low-quality evidence suggests paracetamol as effective as indomethacin in closing a PDA. There was no difference in neurodevelopmental outcome in children exposed to paracetamol compared to ibuprofen; however the quality of evidence is low and comes from only one study. In view of concerns raised regarding neurodevelopmental outcomes following prenatal and postnatal exposure to paracetamol, long-term follow-up to at least 18 to 24 months' postnatal age must be incorporated in any studies of paracetamol in the newborn population. At least 19 ongoing trials have been registered. Such trials are required before any recommendations for the possible routine use of paracetamol in the newborn population can be made.
Topics: Acetaminophen; Administration, Oral; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Injections, Intravenous; Oxygen Inhalation Therapy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29624206
DOI: 10.1002/14651858.CD010061.pub3 -
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