-
The Cochrane Database of Systematic... Jan 2007Non-oliguric hyperkalaemia of the newborn is defined as a plasma potassium level > 6.5 mmol/L in the absence of acute renal failure. Hyperkalaemia is a common... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Non-oliguric hyperkalaemia of the newborn is defined as a plasma potassium level > 6.5 mmol/L in the absence of acute renal failure. Hyperkalaemia is a common complication in the first 48 hours of life in very low birth weight (birth weight < 1500 g) and/or very preterm newborns (< 32 weeks gestational age).
OBJECTIVES
To determine the effectiveness and safety of interventions for non-oliguric hyperkalaemia [for the purpose of this review defined as serum potassium > 6.0 mmol/L ( the clinical setting in which interventions would likely be introduced prior to reaching a grossly abnormal level) and a urine output > 0.5 ml/kg/hour] in preterm or very low birth weight (VLBW) infants during their first 72 hours of life.
SEARCH STRATEGY
The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2006) was searched to identify relevant randomised and quasi-randomised controlled trials. The following data bases were searched in June 2006; MEDLINE from 1966, EMBASE from 1980, CINAHL from 1982.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials conducted in preterm and/or VLBW neonates with a diagnosis of non-oliguric hyperkalaemia. The interventions included were those aimed at redistributing serum potassium (sodium bicarbonate or insulin and glucose) or increasing the elimination of potassium from the body [diuretics (any type) or ion exchange resins (any type), or exchange transfusion, or peritoneal dialysis, or salbutamol, or albuterol] or counteracting potential arrhythmias from hyperkalaemia (calcium) vs. placebo or no intervention; or comparing any two of these interventions. The primary outcome measure was 'All cause mortality during initial hospital stay'. Secondary outcomes included common adverse outcomes seen in infants born preterm.
DATA COLLECTION AND ANALYSIS
The standard review methods of the Cochrane Neonatal Review Group were used. All studies identified as potentially relevant by the literature search were assessed for inclusion in the review by the two authors. The statistical methods included relative risk (RR), risk difference (RD), number needed to treat to benefit (NNTB) or number needed to treat to harm (NNTH) for dichotomous and weighed mean difference (WMD) for continuous outcomes reported with 95% confidence intervals (CI). A fixed effects model was used for meta-analysis. Heterogeneity was assessed using the I squared (I(2 )) statistic.
MAIN RESULTS
Three randomized trials, enrolling 74 preterm infants (outcome data available on 71 infants) evaluated interventions for hyperkalemia. Urine output was ascertained only in one study (Hu 1999). In none of the trials could we ascertain that allocation to the comparison groups was concealed. The sample sizes of the three trials were very small with 12 (Malone 1991), 19 (Singh 2002) and 40 infants enrolled (Hu 1999). The intervention and the outcomes assessments could not be blinded to the clinical staff in two trials (Hu 1999; Malone 1991). In one study (Malone 1991), glucose and insulin, compared to cation-exchange resin, caused a reduction in all cause mortality that was of borderline statistical significance: RR 0.18 (95% CI 0.03, 1.15); RD -0.66 (95% CI -1.09, -0.22); NNTB 2 (95% CI 1, 5)]. In the study of Hu (Hu 1999), the incidence of intraventricular haemorrhage > grade 2 was significantly reduced [RR 0.30 (95% CI; 0.10, 0.93); RD -0.35 (95% CI; -0.62, -0.08); NNTB 3 (95% CI; 2, 13). Albuterol inhalation vs. saline inhalation changed serum K+ from baseline at 4 hours [WMD -0.69 mmol/L (95% CI; -0.87, -0.51)] and at 8 hours [WMD -0.59 mmol/L (95% CI; -0.78, -0.40)] after initiation of treatment. No differences were noted in mortality or other clinical outcomes (Singh 2002). No serious side effects were noted with either the combination of insulin and glucose or albuterol inhalation. Other interventions that we listed in our objectives have not been studied to date.
AUTHORS' CONCLUSIONS
In view of the limited information from small studies of uncertain quality, no firm recommendations for clinical practice can be made. It appears that the combination of insulin and glucose is preferred over treatment with rectal cation-resin for hyperkalaemia in preterm infants. Both the combination of insulin and glucose and albuterol inhalation deserve further study. The two interventions could possibly be tested against each other. The effectiveness of other potentially effective interventions for non-oliguric hyperkalaemia (diuretics, exchange transfusion, peritoneal dialysis and calcium) have not been tested in randomized controlled trials.
Topics: Albuterol; Glucose; Humans; Hyperkalemia; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Insulin; Polystyrenes; Randomized Controlled Trials as Topic
PubMed: 17253550
DOI: 10.1002/14651858.CD005257.pub2 -
The Cochrane Database of Systematic... Jan 2006The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex.
OBJECTIVES
The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage and slippage, safety, and user preferences.
SEARCH STRATEGY
We searched computerized databases for randomized controlled trials of nonlatex condoms. We also wrote to the manufacturers of nonlatex condoms and known investigators in an attempt to locate any other trials not identified in our search.
SELECTION CRITERIA
The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom.
DATA COLLECTION AND ANALYSIS
We evaluated all titles and abstracts located in the literature searches for inclusion. Two authors independently extracted data from the identified studies. We analyzed data with RevMan. The Peto odds ratio (Peto OR) with 95% confidence interval (CI) was calculated for each outcome of contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety, and user preference. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques.
MAIN RESULTS
While the eZ.on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. The nonlatex condoms had significantly higher rates of clinical breakage than their latex comparison condoms: the Peto OR for clinical breakage ranged from 2.6 (95% CI 1.6 to 4.3) to 5.0 (95% CI 3.6 to 6.8). Few adverse events were reported. Substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others.
AUTHORS' CONCLUSIONS
Although the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities, or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of the nonlatex condoms requires more research.
Topics: Condoms; Contraception; Humans; Latex; Male; Polystyrenes; Polyurethanes; Randomized Controlled Trials as Topic
PubMed: 16437459
DOI: 10.1002/14651858.CD003550.pub2