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The Cochrane Database of Systematic... Jan 2021Symptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.
OBJECTIVES
To determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.
SELECTION CRITERIA
We included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.
DATA COLLECTION AND ANALYSIS
We used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.
MAIN RESULTS
We included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.
AUTHORS' CONCLUSIONS
High-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.
Topics: Bias; Bronchopulmonary Dysplasia; Cause of Death; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Gastrointestinal Hemorrhage; Humans; Incidence; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Ligation; Oxygen Inhalation Therapy; Placebos; Randomized Controlled Trials as Topic
PubMed: 33448032
DOI: 10.1002/14651858.CD013133.pub2 -
Journal of Wound Care Mar 2016Negative pressure wound therapy (NPWT) is a widely accepted treatment modality for open or infected wounds. Premature ending of NPWT occasionally occurs due to negative... (Comparative Study)
Comparative Study Review
OBJECTIVE
Negative pressure wound therapy (NPWT) is a widely accepted treatment modality for open or infected wounds. Premature ending of NPWT occasionally occurs due to negative effects on the quality of life (QoL), however, the actual impact on QoL is unknown. The aim of this review is to analyse the effect of NPWT versus standard wound care (SWC) on QoL when used for the treatment of open or infected wounds.
METHOD
A systematic literature search in a range of databases (PubMed, CINAHL, Medline, Web of Science, Science Direct Freedom Collection, SwetsWise, PSYCArticles and Infrotrac Custom Journals) using the following search terms; 'standard wound care', 'wound dressing', 'dressing', 'treatment', OR 'negative pressure wound therapy [MESH]', OR 'vacuum assisted closure' AND 'quality of life [MESH]', 'patient-satisfaction', OR 'experiences' was performed. Methodological quality was assessed using the methodological index for non-randomised studies (MINORS) checklist.
RESULTS
There were 42 studies identified, five matched the inclusion criteria: two randomised clinical trials (RCTs), one clinical comparative study, one exploratory prospective cohort study and one quasi experimental pilot study. Median MINORS-score was 75% (58%-96%). There were seven different questionnaires used to measure QoL or a subsidiary outcome. QoL in the NPWT group was lower in the first week, though no difference in QoL was observed thereafter.
CONCLUSION
This systematic review observed that QoL improved at the end of therapy independent of which therapy was used. NPWT led to a lower QoL during the first week of treatment, possible due to aniexty, after which a similar or better QoL was reported when compared with SWC. It could be suggested that NPWT might be associated with increased anxiety.
DECLARATION OF INTEREST
All authors of this publication have received no financial support or have personal interests conflicting with the objectivity of this manuscript.
Topics: Anxiety; Humans; Negative-Pressure Wound Therapy; Quality of Life; Treatment Outcome; Wound Healing; Wounds and Injuries
PubMed: 26947696
DOI: 10.12968/jowc.2016.25.3.154 -
Clinical Therapeutics Sep 2010The persistence of a patent ductus arteriosus (PDA) in preterm infants complicates their clinical course and may contribute to increased morbidity. Intravenous... (Review)
Review
BACKGROUND
The persistence of a patent ductus arteriosus (PDA) in preterm infants complicates their clinical course and may contribute to increased morbidity. Intravenous preparations of ibuprofen constitute one of the standard therapies for closure of a PDA. However, the unavailability of intravenous ibuprofen in certain regions of the world and the availability of inexpensive oral preparations has led to off-label nasogastric administration of oral ibuprofen in preterm infants with PDA.
OBJECTIVE
This article reviews and comments on the evidence for the enteral use of oral formulations of racemic ibuprofen for PDA closure in preterm infants, with a focus on the risk of necrotizing enterocolitis (NEC).
METHODS
MEDLINE, Current Contents, and Google Scholar were searched in April 2010 for trials of enteral ibuprofen in the treatment of PDA in preterm or low-birth-weight infants using the terms treatment, pharmacokinetics, ibuprofen, oral, enteral, patent ductus arteriosus, PDA, preterm, premature, low birth weight, infant, and newborn. Relevant congress Web sites were also searched for relevant abstracts.
RESULTS
The literature search identified 2 pharmacokinetic studies involving 32 infants and 13 clinical efficacy studies involving 306 infants treated with enteral ibuprofen. The clinical studies reported some benefit for enteral ibuprofen relative to the comparators. However, these studies had methodologic limitations, including small numbers of subjects, lack of blinding, inclusion of preterm infants with a higher gestational age, customized treatment regimens, and second-order statistical error that prevented conduct of a systematic review. When the results of all studies were pooled, NEC was reported in a total of 46 of 281 infants (16%) receiving enteral ibuprofen and 21 of 83 infants (25%) receiving indomethacin. This rate of NEC with enteral ibuprofen was twice that reported for intravenous ibuprofen in a recent meta-analysis (27/356 [8%]).
CONCLUSIONS
The evidence supporting the off-label use of enteral ibuprofen for PDA in preterm infants is weak. Well-designed, appropriately powered pharmacologic and controlled clinical studies are needed before use of enteral ibuprofen can be recommended. In countries where an intravenous formulation of racemic ibuprofen is approved, off-label use of enteral racemic ibuprofen cannot be supported.
Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Ductus Arteriosus, Patent; Humans; Ibuprofen; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Treatment Outcome
PubMed: 21194597
DOI: 10.1016/j.clinthera.2010.08.011 -
Nefrologia : Publicacion Oficial de La... 2007To estimate whether continuous veno-venous hemodiafiltration (CVVHDF) is superior to intermittent hemodialysis (IHD) in terms of survival of adult patients with acute... (Comparative Study)
Comparative Study Review
OBJECTIVE
To estimate whether continuous veno-venous hemodiafiltration (CVVHDF) is superior to intermittent hemodialysis (IHD) in terms of survival of adult patients with acute renal failure (ARF) admitted to the Intensive Care Unit.
SELECTION OF STUDIES
Controlled clinical trials (CCT) and systematic reviews comparing CWHDF and IHD for managing ARF in adult patients (age > 19 years). Observational and case series were excluded. SEARCH SOURCES: The basic syntax <
> was used to search Pub Med and Ovid System databases. A manual search was done by reviewing the references in the corresponding topic of UpToDate. ANALYSIS
Data were extracted by two author and their methodological quality was assessed according to the Cochrane Renal Group recommendations that include the procedure for assigning, blinding, intention to treat analysis, and follow-up. OUTCOMES VARIABLES: All data relating to mortality were extracted, specifying the time of collection, time and circumstances (mortality in the ICU or hospitalization). Values gathered are expressed as mortality rates in both the experimental group (CVVHDF) and the control group (IHD), indicating the absolute risk reduction (ARR) and its 95% confidence interval. OUTCOMES AGGREGATION: Studies meeting clinical and methodological homogeneity criteria were combined with the fix effect model by using the Review Manager tool from Cochrane Collaboration. Methodological heterogeneity was analyzed by using the chi-squared test for n-1 freedom degrees, with an alpha value of 0.05. A sensitivity analysis was done adjusting for methodological quality to confirm the results obtained.
RESULTS
Seven clinical trials directly comparing the survival of severe ARF patients in a prospective, randomized, and controlled way were identifiec. Almost all published estudies have quality problems because of being too small to study survival rates, treatment allocation problems and high numbers of loss to follow-up, differences in initial severity levels, or to premature study closure. When combining the results, it was observed that mortality was 64% for IHD and 65% for CVVHDF, with a relative risk of 0.98 (95% CI 0.89-1.07), p = 0.65, with no statistically significant heterogeneity between studies included. When excluding from the analysis the most questionable study due to selection bias, high loss to follow-up (21%), and baseline differences in co-variables influencing the study outcomes, the results are not changed, the observed mortality was 67% for extra-renal intermittent depurative techniques versus 65% for continous ones, with a relative risk of 1.03 (95% CI 0.94-1.14), p = 0.54, again with no statistically significant heterogeneity between studies included.
CONCLUSION
CVVHDF does not offer any benefit as compared to IHD in terms of survival and according to available data from the literature. However, continuous techniques bring other potential benefits such as hemodynamic stability, better tolerability of ultrafiltration, and depuration of solutes, which merit a systematic review to estimate and quantify their magnitude, and which would allow for better defining their place in the therapeutic armamentarium available for this high-mortality condition.
Topics: Acute Kidney Injury; Hemodiafiltration; Humans; Renal Dialysis; Veins
PubMed: 17763635
DOI: No ID Found -
World Journal of Orthopedics Aug 2017To better understand how pediatric floating knee injuries are managed after the wide spread use of new orthopaedic technology.
AIM
To better understand how pediatric floating knee injuries are managed after the wide spread use of new orthopaedic technology.
METHODS
We searched EMBASE, COCHRANE and MEDLINE computerized literature databases from the earliest date available in the databases to February 2017 using the following search term including variants and pleural counterparts: Pediatric floating knee. All studies were thoroughly reviewed by multiple authors. Reference lists from all articles were scrutinized to identify any additional studies of interest. A final database of individual patients was assembled from the literature. Univariate and multivariate statistical tests were applied to the assembled database to assess differences in outcomes.
RESULTS
The English language literature contains series with a total of 97 pediatric patients who sustained floating knee injuries. Patients averaged 9.3 years of age and were mostly male (73). Approximately 25% of the fractures were open injuries, more tibia (27) than femur (10). Over 75% of the fractures of both the tibia and the femur involved the diaphysis. More than half (52) of the patients were treated non-operatively for both fractures. As a sequela of the injury 32 (33%) patients were left with a limb length discrepancy, 24 (25%) patients had lengthening of the injured limb at follow up, while 8 (8%) had shortening of the affected limb. Infection developed in 9 patients and 3 had premature physeal closure. Younger patients were more likely to be treated non-operatively ( < 0.001) and patients treated with operative intervention had statistically significant shorter hospital length of stays ( = 0.001).
CONCLUSION
Given the predominance of non-operative management in published studies, the available literature is not clinically relevant since the popularization of internal fixation for pediatric long-bone fractures.
PubMed: 28875130
DOI: 10.5312/wjo.v8.i8.638 -
The Cochrane Database of Systematic... Nov 2015Patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. Phototherapy is a common treatment for jaundice in preterm infants.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. Phototherapy is a common treatment for jaundice in preterm infants. However, phototherapy has been associated with failure of closure of the ductus arteriosus in preterm infants.
OBJECTIVES
To determine if chest shielding of preterm infants receiving phototherapy reduces the incidence of clinically and/or haemodynamically significant PDA and reduces morbidity secondary to PDA.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2015, Issue 3), MEDLINE, EMBASE, CINAHL, previous reviews, cross-references, abstracts, proceedings of scientific meetings, and trial registries through March 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs), cluster-RCTs, or quasi-RCTs of chest shielding during phototherapy compared to sham shielding or no shielding for the prevention of a haemodynamically or clinically significant PDA in preterm infants.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed studies for eligibility and quality and extracted data. We defined a clinically significant PDA as the presence of a PDA with clinical signs of an effect on organ function attributable to the ductus arteriosus. We defined a haemodynamically significant PDA as clinical and/or echocardiographic signs of a significant ductus arteriosus effect on blood flow.
MAIN RESULTS
We included two small trials enrolling very preterm infants (Rosenfeld 1986; Travadi 2006). We assessed both as at high risk of bias. No study reported clinically significant PDA, defined as the presence of a PDA with clinical symptoms or signs attributable to the effect of a ductus arteriosus on organ function. Rosenfeld 1986 reported a non-significant reduction in haemodynamically significant PDA with left atrial to aortic root ratio greater than 1.2 (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.05 to 1.01; 74 infants) but a statistically significant risk difference (RD -0.18, 95% CI -0.34 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 3 to 33). Rosenfeld 1986 reported a significant reduction in PDA detected by murmur (RR 0.50, 95% CI 0.29 to 0.88; RD -0.30, 95% CI -0.52 to -0.08; NNTB 3, 95% CI 2 to 12; 74 infants). Rosenfeld 1986 reported a significant reduction in treatment with indomethacin (RR 0.12, 95% CI 0.02 to 0.88; RD -0.21, 95% CI -0.35 to -0.06; NNTB 5, 95% CI 3 to 17; 74 infants), and only one infant had a ductal ligation in the no-shield group. There were no other significant outcomes, including mortality to discharge or 28 days, days in oxygen, days on mechanical ventilation, days in hospital, intraventricular haemorrhage, retinopathy of prematurity, or exchange transfusion.
AUTHORS' CONCLUSIONS
The available evidence is very low quality and insufficient to assess the safety or efficacy of chest shield during phototherapy for prevention of PDA in preterm infants. Further trials of chest shielding are warranted, particularly in settings where infants are not receiving prophylactic or early echocardiographic targeted cyclo-oxygenase inhibitors for PDA.
Topics: Ductus Arteriosus, Patent; Humans; Infant, Extremely Premature; Infant, Newborn; Jaundice; Phototherapy; Radiation Protection; Randomized Controlled Trials as Topic; Torso
PubMed: 26523368
DOI: 10.1002/14651858.CD009816.pub2 -
Journal of Orthopaedic Surgery and... Jan 2023The quality of reduction is an important factor affecting clinical outcomes for displaced femoral neck fractures (FNFs). However, concerns remain about the invasiveness... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The quality of reduction is an important factor affecting clinical outcomes for displaced femoral neck fractures (FNFs). However, concerns remain about the invasiveness of open reduction and internal fixation (ORIF) as compared to that of closed reduction and internal fixation (CRIF), and the choice between ORIF and CRIF as an optimal treatment strategy for displaced pediatric FNF remains controversial.
MATERIALS AND METHODS
MEDLINE, Embase, and the Cochrane Library were systematically searched for studies published up to December 22, 2022, that compared ORIF and CRIF techniques for treating FNF in children. Pooled analysis identified differences in surgical outcomes between ORIF and CRIF, especially regarding postoperative complications, such as osteonecrosis of the femoral head (ONFH), nonunion, coxa vara deformity, leg-length discrepancy LLD, and premature physeal closure (PPC).
RESULTS
We included 15 studies with 635 pediatric FNF cases in our review. Of these, 324 and 311 were treated with ORIF and CRIF, respectively. The pooled analysis revealed that no significant differences existed between each reduction technique for ONFH (odds ratio [OR] = 0.89; 95% confidence interval [CI] 0.51-1.56; P = 0.69), nonunion (OR = 0.51; 95% CI 0.18-1.47; P = 0.21), coxa vara deformity (OR = 0.58; 95% CI 0.20-1.72; P = 0.33), LLD (OR = 0.57; 95% CI 0.18-1.82; P = 0.35), and PPC (OR = 0.72; 95% CI 0.11-4.92; P = 0.74).
CONCLUSIONS
Despite concerns about the invasiveness of ORIF, no differences in complications exist between ORIF and CRIF after FNF in children. Therefore, we believe that ORIF should be performed in FNF when the fracture is irreducible by closed manner.
Topics: Humans; Child; Coxa Vara; Fracture Fixation, Internal; Femoral Neck Fractures; Open Fracture Reduction; Plastic Surgery Procedures; Retrospective Studies; Treatment Outcome
PubMed: 36650541
DOI: 10.1186/s13018-023-03525-x -
BMC Psychiatry Nov 2019Patients suffering from schizophrenia spectrum disorders demonstrate various cognitive deficiencies, the most pertinent one being impairment in autobiographical memory....
BACKGROUND
Patients suffering from schizophrenia spectrum disorders demonstrate various cognitive deficiencies, the most pertinent one being impairment in autobiographical memory. This paper reviews quantitative research investigating deficits in the content, and characteristics, of autobiographical memories in individuals with schizophrenia. It also examines if the method used to activate autobiographical memories influenced the results and which theoretical accounts were proposed to explain the defective recall of autobiographical memories in patients with schizophrenia.
METHODS
PsycINFO, Web of Science, and PubMed databases were searched for articles published between January 1998 and December 2018. Fifty-seven studies met the inclusion criteria. All studies implemented the generative retrieval strategy by inducing memories through cue words or pictures, the life-stage method, or open-ended retrieval method. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement guidelines were followed for this review.
RESULTS
Most studies reported that patients with schizophrenia retrieve less specific autobiographical memories when compared to a healthy control group, while only three studies indicated that both groups performed similarly on memory specificity. Patients with schizophrenia also exhibited earlier reminiscence bumps than those for healthy controls. The relationship between comorbid depression and autobiographical memory specificity appeared to be independent because patients' memory specificity improved through intervention, but their level of depression remained unchanged. The U-shaped retrieval pattern for memory specificity was not consistent. Both the connection between the history of attempted suicide and autobiographical memory specificity, and the relationship between psychotic symptoms and autobiographical memory specificity, remain inconclusive. Patients' memory specificity and coherence improved through cognitive training.
CONCLUSIONS
The overgeneral recall of autobiographical memory by patients with schizophrenia could be attributed to working memory, the disturbing concept of self, and the cuing method implemented. The earlier reminiscence bump for patients with schizophrenia may be explained by the premature closure of the identity formation process due to the emergence of psychotic symptoms during early adulthood. Protocol developed for this review was registered in PROSPERO (registration no: CRD42017062643).
Topics: Adult; Cues; Female; Humans; Male; Memory Disorders; Memory, Episodic; Mental Recall; Schizophrenia; Schizophrenic Psychology
PubMed: 31727046
DOI: 10.1186/s12888-019-2346-6 -
Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants.The Cochrane Database of Systematic... Jul 2011Patent ductus arteriosus (PDA) complicates the clinical course of preterm infants and increases the risk of adverse outcomes. Indomethacin has been the standard... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patent ductus arteriosus (PDA) complicates the clinical course of preterm infants and increases the risk of adverse outcomes. Indomethacin has been the standard treatment to close a PDA but is associated with renal, gastrointestinal and cerebral side-effects. Ibuprofen has less effect on blood flow velocity to important organs.
OBJECTIVES
To determine the effectiveness and safety of prophylactic ibuprofen compared to placebo/no intervention in the prevention of PDA in preterm infants.
SEARCH STRATEGY
Randomized controlled trials of prophylactic ibuprofen were identified by searching in The Cochrane Library, MEDLINE, CINAHL, EMBASE and trials registries in December 2010.
SELECTION CRITERIA
Randomized or quasi-randomised controlled trials comparing ibuprofen with placebo/no intervention or other cyclo-oxygenase inhibitor drugs to prevent PDA in preterm and/or low birth weight infants.
DATA COLLECTION AND ANALYSIS
Outcomes data including presence of PDA on day three, need for surgical ligation or rescue treatment with cyclo-oxygenase inhibitors, mortality, intraventricular haemorrhage (IVH), renal, pulmonary and gastrointestinal complications were extracted. Meta-analyses were performed and treatment estimates are reported as typical weighted mean difference, relative risk (RR), risk difference (RD) and, if statistically significant, number needed to treat to benefit (NNT) or number needed to treat to harm (NNH) along with their 95% confidence intervals (CI).
MAIN RESULTS
In this update, seven studies (n = 931) comparing prophylactic ibuprofen with placebo/no intervention are included. Ibuprofen decreased the incidence of PDA on day three [typical RR 0.36 (95% CI 0.29 to 0.46); typical RD -0.27 (95% CI -0.32 to -0.21); NNT 4 (95% CI 3 to 5)], decreased the need for rescue treatment with cyclo-oxygenase inhibitors and decreased the need for surgical ligation. Results from two studies administering oral ibuprofen had similar results, but showed an increased risk of gastrointestinal bleeding (NNH 4, 95% CI 2 to 17). In the control group the spontaneous closure rate was 58% by day three. Ibuprofen negatively affects renal function. No significant differences in mortality, IVH, chronic lung disease were found.
AUTHORS' CONCLUSIONS
Prophylactic use of ibuprofen decreased the incidence of PDA, decreased the need for rescue treatment with cyclo-oxygenase inhibitors and decreased the need for surgical closure. In the control group, the PDA closed spontaneously by day three in 58% of the neonates. Prophylactic treatment exposes many infants to a drug that has concerning renal and gastrointestinal side effects without conferring any important short-term benefits and is not recommended. Until long-term follow-up results are published from the trials included in this updated review, no further trials of prophylactic ibuprofen are recommended.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Enzyme Inhibitors; Humans; Ibuprofen; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Randomized Controlled Trials as Topic
PubMed: 21735396
DOI: 10.1002/14651858.CD004213.pub3 -
The Cochrane Database of Systematic... 2003Patent ductus arteriosus (PDA) with significant left to right shunt in preterm infants increases morbidity and mortality. Early closure of the ductus arteriosus may be... (Review)
Review
BACKGROUND
Patent ductus arteriosus (PDA) with significant left to right shunt in preterm infants increases morbidity and mortality. Early closure of the ductus arteriosus may be achieved pharmacologically using cyclooxygenase inhibitors, or by surgery. The efficacy of both treatment modalities is well established. However, the preferred initial treatment of a symptomatic PDA in a preterm infant, surgical ligation or trial of indomethacin, has not been well established.
OBJECTIVES
To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (using indomethacin, ibuprofen, or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA.
SEARCH STRATEGY
The standard search strategy of the Cochrane Neonatal Review Group was used. This included search of electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2002), MEDLINE (1966 - December 2002), CINAHL (1982 - December 2002), EMBASE (1980 - December 2002); and hand search of abstracts of Pediatric Academic Societies annual meetings published in Pediatric Research (1990 - April 2002). No language restrictions were applied.
SELECTION CRITERIA
All trials 1) using randomized or quasi-randomized patient allocation, 2) in preterm infants < 37 weeks gestational age or low-birth-weight infants (< 2500 grams) with symptomatic PDA in the neonatal period (< 28 days) and 3) comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA.
DATA COLLECTION AND ANALYSIS
Assessment of methodological quality and extraction of data for included trials was undertaken independently by the authors. RevMan 4.1 was used for analysis of the data.
MAIN RESULTS
Only one study, trial B in the report of Gersony 1983, was found eligible. The trial compared the effect of surgical ligation of PDA versus medical treatment with indomethacin, each used as the primary treatment. No trials comparing surgery to other cyclooxygenase inhibitors (ibuprofen, mefenamic acid) were found. Trial B of Gersony 1983 enrolled 154 infants. The study found no statistically significant difference between surgical closure and indomethacin treatment in mortality during hospital stay, chronic lung disease, other bleeding, necrotizing enterocolitis, sepsis, creatinine level, or intraventricular hemorrhage. There was a statistically significant increase in the surgical group in incidence of pneumothorax [RR 2.68 (95% CI 1.45, 4.93); RD 0.25 (95% CI 0.11, 0.38); NNH 4 (95% CI 3, 9)] and retinopathy of prematurity grade III and IV [RR 3.80 (95% CI 1.12, 12.93); RD 0.11 (95% CI 0.02, 0.20), NNH 9 (95% CI 5, 50] compared to the indomethacin group. There was as expected 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, 0.27); RD -0.32 (95% CI -0.43, -0.21), NNT 3 (95% CI 2, 4)].
REVIEWER'S CONCLUSIONS
The data regarding net benefit/harm are insufficient to make a conclusion as to whether surgical ligation or medical treatment with indomethacin is preferred as 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; Randomized Controlled Trials as Topic
PubMed: 12917997
DOI: 10.1002/14651858.CD003951