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A Ohlsson

Publications and source records attributed to A Ohlsson.

At least 19 recordsLinked to original sources

Respiratory syncytial virus vaccine: a systematic overview with emphasis on respiratory syncytial virus subunit vaccines.

OBJECTIVE: To explore whether RSV vaccines are efficacious in preventing respiratory syncytial virus (RSV) lower respiratory infection (LRI). METHODS: Randomized clinical trials were sought through Medline using the following search terms: "RSV" or "RSV infection" and "viral vaccine". Randomized controlled trials in adults or children that provided data on clinical outcomes (RSV LRIs, all LRI, all RSV infections) were included. Control groups could receive placebo or another vaccine. Qualitative assessment and summary data were obtained independently by three authors and summarized on a pre-printed form. Where disagreements occurred, the studies were reviewed by all investigators. These disagreements were mainly clerical, such as misinterpretations of the table or text or transcription errors. Consensus was obtained for all studies. Summary statistics consists of relative risk (RR) and number needed to vaccinate to prevent the above outcomes. RESULTS: Because of the outcomes examined, only studies of a purified F protein subunit (PFP) vaccine were included in the meta-analysis. These clinical trials were phase I studies to determine vaccine safety rather than efficacy. Efficacy of PFP-1 or PFP-2 vaccine were analyzed together. A statistically significant RR in overall number of RSV infections was observed RR 0.55 (95%CI, 0.35, 0.88), but the test of heterogeneity was significant raising doubts about the validity of this conclusion. The effect of vaccination on RSV LRI did not reach statistical significance. CONCLUSIONS: RSV subunit vaccines were found to reduce the overall incidence of all RSV infections. However, RSV subunit vaccines must be tested in large field trials because of concerns about the appropriateness of pooling, the risk of publication bias and the fact that the clinically important outcome of RSV LRI was not reduced.

Adult↗

Secular trends in congenital anomaly-related fetal and infant mortality in Canada, 1985-1996.

Prenatal diagnosis of major congenital anomalies and subsequent termination of affected pregnancies has been widely available as part of routine obstetric care in recent years. In this study, vital statistical data on stillbirths, live births, and infant deaths were used to examine secular trends in gestational age-specific and category-specific fetal and infant mortality due to congenital anomalies in Canada (excluding Ontario and Newfoundland) from 1985-1996. Comparisons of the rates between 1985-1987 and 1994-1996 were made using relative risks and 95% confidence intervals (CI). The overall fetal mortality rate due to congenital anomalies increased significantly, from 68.0 per 100,000 total births in 1985-1987 to 78.6 per 100,000 total births in 1994-1996, while the overall infant mortality rate due to congenital anomalies decreased significantly over the same period, from 2.47 to 1.79 per 1,000 live births. The fetal death rate due to congenital anomalies at 20-21 weeks of gestation increased approximately five-fold (relative risk [RR] = 4.83, 95% CI = 3.28-7.11) from 4.5 to 21.5 per 100,000 fetuses at risk, while the rate at 37-41 weeks decreased by 30% (RR = 0.70, 95% CI = 0.50-0.97). Fetal death rates among pregnancies at 20-25 weeks of gestation increased in all categories of congenital anomaly except anencephaly and respiratory system anomalies. Congenital anomaly-related fetal and infant deaths have increased at early gestation but declined at later gestation in Canada. These changes suggest an increase in prenatal diagnosis and selective termination of pregnancies with congenital anomalies in recent years.

Canada↗

Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants.

BACKGROUND: The prophylactic administration of indomethacin reduces the frequency of patent ductus arteriosus and severe intraventricular hemorrhage in very-low-birth-weight infants (those with birth weights below 1500 g). Whether prophylaxis with indomethacin confers any long-term benefits that outweigh the risks of drug-induced reductions in renal, intestinal, and cerebral blood flow is not known. METHODS: Soon after they were born, we randomly assigned 1202 infants with birth weights of 500 to 999 g (extremely low birth weight) to receive either indomethacin (0.1 mg per kilogram of body weight) or placebo intravenously once daily for three days. The primary outcome was a composite of death, cerebral palsy, cognitive delay, deafness, and blindness at a corrected age of 18 months. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly within the same time frame. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, ultrasonographic evidence of intracranial abnormalities, necrotizing enterocolitis, and retinopathy. RESULTS: Of the 574 infants with data on the primary outcome who were assigned to prophylaxis with indomethacin, 271 (47 percent) died or survived with impairments, as compared with 261 of the 569 infants (46 percent) assigned to placebo (odds ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4; P=0.61). Indomethacin reduced the incidence of patent ductus arteriosus (24 percent vs. 50 percent in the placebo group; odds ratio, 0.3; P<0.001) and of severe periventricular and intraventricular hemorrhage (9 percent vs. 13 percent in the placebo group; odds ratio, 0.6; P=0.02). No other outcomes were altered by the prophylactic administration of indomethacin. CONCLUSIONS: In extremely-low-birth-weight infants, prophylaxis with indomethacin does not improve the rate of survival without neurosensory impairment at 18 months, despite the fact that it reduces the frequency of patent ductus arteriosus and severe periventricular and intraventricular hemorrhage.

Blindness↗

Comparison of maternal and infant outcomes between vacuum extraction and forceps deliveries.

The authors conducted a population-based historical cohort study in the Canadian province of Quebec to assess the maternal and infant outcomes associated with vacuum extraction and forceps deliveries. The study database contains information on 305,391 mother-infant dyads (linked by a common institutional code and hospital chart number) for singleton live vaginal births with a nonbreech presentation at the gestational age of 37 or more completed weeks and a birth weight between 2,500 and 4,000 g during fiscal years 1991/1992 to 1995/1996. Of the births, 31,015 were delivered by vacuum extraction, and 18,727 were delivered by forceps. Compared with delivery by forceps, the adjusted risk ratios for third-/fourth-degree perineal laceration, intracranial hemorrhage, subdural or cerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, cephalhematoma, and neonatal in-hospital death were 0.48 (95% confidence interval: 0.45, 0.50), 1.28 (95% confidence interval: 0.73, 2.25), 0.97 (95% confidence interval: 0.49, 1.93), 0.99 (95% confidence interval: 0.16, 5.97), 5.44 (confidence interval: 1.26, 23.43), 2.02 (95% confidence interval: 1.89, 2.16), and 0.93 (95% confidence interval: 0.32, 2.70), respectively. The authors conclude that vacuum extraction causes less maternal trauma but may increase the risk of cephalhematoma and certain types of intracranial hemorrhage (e.g., subarachnoid hemorrhage).

Adult↗

Evidence for changing guidelines for routine screening for retinopathy of prematurity.

CONTEXT: Existing guidelines recommended by the Canadian Pediatric Society (CPS) and American Academy of Pediatrics (AAP) for routine screening for retinopathy of prematurity (ROP) remain controversial. OBJECTIVE: To determine whether current guidelines for routine screening for ROP should be changed. DESIGN: We examined data that were collected as part of a larger study of 14 neonatal intensive care units (NICUs) in Canada. We examined the effect of strategies using different birth weight (BW) and gestational age (GA) criteria for routine ROP screening, and performed a cost-effectiveness analysis. SETTING: The 14 NICUs (except one) are regional tertiary level referral centres serving geographic regions of Canada, and include approximately 60% of all tertiary-level NICU beds in Canada. PATIENTS: This large cohort included all 16 424 infants admitted to 14 Canadian NICUs from January 8, 1996, to October 31, 1997. INTERVENTIONS: None. MAIN OUTCOME MEASURE: Treatment for ROP. RESULTS: The most cost-effective strategy was to routinely screen only infants having a BW of 1200 g or less. This included all infants treated for ROP (except 1 outlier at 32 weeks GA and 1785 g BW), at a marginal cost per additional person with improved vision of $513 081 for screening patients between 28 weeks GA and 1200 g BW, compared with $1 800 039 and $2 075 874 for using the current AAP and CPS guidelines, respectively (cryotherapy outcomes). Results for laser therapy were similar, but costs were slightly lower. This strategy reduced the number of infants screened under the current CPS guidelines by 46%. CONCLUSION: Screening only infants having a BW of 1200 g or less is the most cost-effective strategy for routine ROP screening.

Birth Weight↗

Alpha-1 proteinase inhibitor (a1PI) for preventing chronic lung disease in preterm infants.

BACKGROUND: Inflammation of the pulmonary parenchyma is one of the important mechanisms implicated in development of chronic lung disease (CLD) in preterm neonates. Release of enzymes and other anti - oxidants following cell damage is considered to be responsible for the damage to lung tissue. Various strategies have been attempted to counteract enzymatic damage to pulmonary parenchyma and to prevent CLD. OBJECTIVES: This review examines the effectiveness of alpha 1 proteinase inhibitor (a1PI) for the prevention of CLD defined as requirement of supplemental oxygen at 36 weeks post menstrual age (PMA) in preterm neonates. SEARCH STRATEGY: A literature search was performed using the following databases: MEDLINE (1966 - February 2001), EMBASE (1980 -February 2001), CINAHL (1982 - February 2001), Cochrane Controlled Trials Register (Issue 1, 2001 of Cochrane Library) and abstracts from the annual meetings of the Society of Pediatric Research, American Pediatric Society and Pediatric Academic Societies published in Pediatric Research (1991-2000). No language restrictions were applied. SELECTION CRITERIA: Selection criteria applied to the clinical trials were: 1. The population had to be preterm neonates 2. The intervention had to be administration of a1PI compared to placebo or no treatment within the first week of life 3. The eligible studies had to include any of the following outcomes: a. prevention of CLD b. reduction in duration of assisted ventilation c. reduction in the duration of oxygen requirement d. reduction in the need for systemic antiinflammatory therapy e. reduction in mortality or f. reduction in long term adverse neurological sequelae. 4. The trial had to be randomized or quasi-randomized. DATA COLLECTION AND ANALYSIS: The methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the authors. Data on relevant outcomes were extracted and the effect size was estimated and reported as pooled relative risk (RR), risk difference (RD) and weighted mean difference (WMD) as appropriate. Two strategies were used for analysis : 1. Comparison of 60 mg/kg/dose of a1PI administered for 4 days in first 2 weeks after birth, versus placebo and 2. Comparison of any dose of a1PI administered in first 2 weeks after birth, versus placebo. MAIN RESULTS: Two eligible studies were identified. The methodological qualities of identified studies were good. One study randomized infants to either placebo, or a1PI 60 mg/kg/dose for four doses while in the second study the same investigators explored the efficacy of different dose regimens of a1PI compared to placebo. There was no statistically significant difference in the development of CLD at 36 weeks PMA amongst all randomized infants. For 60 mg/kg/dose for four doses of a1PI compared to placebo the pooled RR was 0.64 [95% CI 0.35, 1.18] and RD was -0.10 [95% CI -0.23, 0.03] while for any doses of a1PI the pooled RR was 0.79 [95% CI 0.44, 1.41], RD was -0.05 [95% CI -0.17, 0.06]. There was a trend towards reduced risk of development of oxygen dependency at 28 days postnatal age, pooled RR 0.81 [95% CI 0.64, 1.01], RD -0.14 [95% CI -0.29, 0.00] for 60 mg/kg/dose for four doses of a1PI compared to placebo. The pooled RR was statistically significant, RR 0.80 [95% CI 0.65, 0.98], RD -0.15 (95 % CI -0.29, -0.01) when any doses of a1PI were combined. The number of patients needed to treat (NNT) with a1PI to prevent one infant developing oxygen dependency at 28 weeks was 7. The benefits of short-term outcomes did not remain for long-term outcomes such as CLD and/or death at 36 weeks post menstrual age (pooled RR 0.84 [95% CI 0.53, 1.34], RD -0.06 [95% CI -0.20, 0.09] for 60 mg/kg/dose and pooled RR 0.95 [95% CI 0.61, 1.49], RD -0.02 [95% CI -0.15, 0.12] for any dose) or risk of development of long term neurodevelopmental abnormalities (pooled RR 1.29 [95% CI 0.43, 3.90], RD 0.03 [95% CI -0.11, 0.18]). In addition, no statistically significant difference was noted in other respiratory parameters such as duration of oxygen requirement or respiratory support. REVIEWER'S CONCLUSIONS: Prophylactic administration of a1PI did not reduce the risk of CLD at 36 weeks or long term adverse developmental outcomes in preterm neonates.

Chronic Disease↗

Cromolyn sodium for the prevention of chronic lung disease in preterm infants.

BACKGROUND: Chronic lung disease (CLD) frequently occurs in preterm infants (< 37 weeks gestational age) and has a multifactorial etiology including inflammation. Cromolyn sodium is a mast cell stabiliser that inhibits neutrophil activation and neutrophil chemotaxis. Therefore it is possible that cromolyn sodium might have a role in the prevention of CLD. OBJECTIVES QUESTION: in preterm infants, does the prophylactic administration of cromolyn sodium reduce the incidence of CLD, mortality or the combined outcome of mortality or CLD at 28 days of life without undue side effects? SEARCH STRATEGY: The search strategy used to identify studies was according to the guidelines of the Cochrane Neonatal Review Group. Searches were made of MEDLINE, EMBASE, CINAHL up to and including December 2000, the Cochrane Library 2000 Issue 4, personal files and reference lists of identified trials. The following terms were used: chronic lung disease, cromolyn sodium or cromoglycate. LIMITS: newborn, infant; human, clinical trial or controlled clinical trial or meta analysis or randomised controlled trial. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled clinical trials involving preterm infants. Initiation of cromolyn sodium administration during the first two weeks of life. The intervention had to include administration of cromolyn sodium by nebulizer or metered dose inhaler with or without spacer device, versus placebo or no intervention. Eligible studies had to include at least one of the following outcomes: overall mortality, CLD at 28 days, CLD at 36 weeks corrected gestational age, or the combined outcome mortality or CLD at 28 days. Secondary outcomes included number of days on oxygen, number of days on mechanical ventilation, patent ductus arteriosus (PDA), air leaks [pulmonary interstitial emphysema (PIE), pneumothorax], any grade of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), sepsis and adverse effects due to cromolyn sodium. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration as described in the Cochrane Collaboration handbook. Both investigators extracted and assessed all data for each study. Any disagreement was resolved by discussion. Relative risk (RR) and risk difference (RD) with 95% confidence intervals (CI) are reported for dichotomous outcomes and weighted mean difference (WMD) for continuous data. Number needed to treat was not calculated as no outcome showed a statistically significant RD. A fixed effect model was used for meta-analysis. MAIN RESULTS: Two eligible studies were identified with small numbers of infants enrolled. Prophylaxis with cromolyn sodium did not result in a statistically significant effect on the combined outcome, death or CLD at 28 days [RR 1.05 (95% CI 0.73, 1.52); RD 0.03 (95% CI -0.20, 0.27)], CLD at 28 days [RR 0.93 (95% CI 0.53, 1.64; RD -0.03 (95% CI -0.27, 0.20)], CLD at 36 weeks corrected gestational age [RR 1.25 (95% CI 0.43, 3.63); RD 0.08 (95% CI -0.29, 0.44)], CLD in survivors at 28 days [RR 0.97 (95% CI 0.58, 1.63); RD -0.02 (95% CI -0.29, 0.26)] or CLD in survivors at 36 weeks corrected gestational age [RR 1.04 (95% CI 0.38, 2.87); RD 0.02 (95% CI -0.40, 0.43)]. Prophylaxis with cromolyn sodium did not show a statistically significant difference in overall mortality [RR 1.31 (95% CI 0.52, 3.29); RD 0.06 (95% CI -0.13, 0.26)]. There were no statistically significant differences in the incidence of air leaks, NEC, IVH, sepsis, days on mechanical ventilation or PDA. No side effects were noted. REVIEWER'S CONCLUSIONS: There is currently no evidence from randomized trials that cromolyn sodium has a role in the prevention of CLD. Cromolyn sodium cannot be recommended for the prevention of CLD in preterm infants. Additional clinical trials do not appear to be justified using the protocols for drug administration used to date unless a more efficient type of delivery device than the jet nebulizer is employed.

Chronic Disease↗

Bronchodilators for the prevention and treatment of chronic lung disease in preterm infants.

BACKGROUND: Chronic lung disease (CLD) occurs frequently in preterm infants (< 37 weeks gestational age) and has a multifactorial etiology. Bronchodilators have the potential effect of dilating small airways with muscle hypertrophy. Increase in compliance and tidal volume and decrease in pulmonary resistance have been documented with use of bronchodilators in short term studies of pulmonary mechanics in infants with CLD. Therefore it is possible that bronchodilators might have a role in the prevention and treatment of CLD. OBJECTIVES: To evaluate the effect of bronchodilators, given prophylactically or as treatment for chronic lung disease, on mortality and other complications of preterm births. SEARCH STRATEGY: The search strategy used to identify studies was according to the guidelines of the Cochrane Neonatal Review Group. Searches were made of MEDLINE 1966 to December 2000, EMBASE 1980 to January 2001, CINAHL 1982 to December 2000, the Cochrane Library Issue 1, 2001, personal files and reference lists of identified trials. The following terms were used: bronchopulmonary dysplasia, chronic lung disease, bronchodilator agents, adrenergic agents, anticholinergic agents, albuterol, aminophylline, atropine, caffeine, clenbuterol, cromakalim, ephedrine, epinephrine, fenoterol, hexoprenaline, ipratropium, isoetharine, isoproterenol, orciprenaline, procaterol, terbutaline, theophylline, tretoquinol. LIMITS: newborn, infant; human, clinical trial or controlled clinical trial, meta analysis, multicenter study or randomised controlled trial. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled clinical trials involving preterm infants. Initiation of bronchodilator therapy had to occur within two weeks of birth for prevention of CLD. For treatment of CLD treatment should have been initiated before discharge from the neonatal unit. The intervention had to include the randomised administration of a bronchodilator either by nebulisation, metered dose inhaler with or without a spacer device, intravenously or orally, versus placebo or no intervention. Eligible studies had to include at least one of the following outcomes: mortality, CLD at 28 days or at 36 weeks corrected GA, number of days on oxygen, number of days on ventilator, patent ductus arteriosus (PDA), pulmonary interstitial emphysema (PIE), pneumothorax, any grade of intraventricular haemorrhage, necrotizing enterocolitis (NEC), sepsis and adverse effects of bronchodilators. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration as described in the Cochrane Collaboration handbook. Two investigators (GN, AO) extracted and assessed all data for each study. Any disagreement was resolved by discussion. Relative risk (RR) and risk difference (RD) with 95% confidence intervals (CI) are reported for dichotomous outcomes and mean difference (WMD) for continuous data. MAIN RESULTS: One eligible study was found dealing with prevention of CLD; this study used salbutamol and enrolled 173 infants. No eligible studies were found dealing with treatment of CLD. Prophylaxis with salbutamol did not show a statistically significant difference in mortality [RR 1.08 (95% CI 0.50, 2.31); RD 0.01 (95% CI -0.09, 0.11)], CLD (mild, moderate or severe) [RR 1.03 (95% CI 0.78, 1.37); RD 0.02 (95% CI -0.13, 0.17)], need for iv dexamethasone [RR 0.77 (95% CI 0.49, 1.19); RD -0.08 (95% CI -0.22, 0.05)], respiratory infections [RR 0.61 (95% CI 0.27, 1.39); RD -0.06 (95% CI -0.16, 0.04)] or positive blood culture [RR 1.06 (95% CI 0.54, 2.06); RD 0.01 (95% CI -0.10, 0.12)]. There was no statistically significant difference in duration of ventilatory support [MD -1.63 days (95% CI -5.63, 2.37)], duration of oxygen supply [MD -2.82 days (95% CI -11.91, 6.27)] or age of weaning from respiratory support (defined as assisted ventilation or oxygen supplementation) [MD -2.87 days (95% CI -11.28, 5.54)]. No side effects due to salbutamol were commented on in this study. REVIEWER'S CONCLUSIONS: There are insufficient data to reliably assess the use of salbutamol for the prevention of CLD. Further clinical trials are necessary to assess the role of salbutamol or other bronchodilator agents in prophylaxis or treatment of CLD.

Bronchodilator Agents↗

Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study.

BACKGROUND: Implantable sensors that monitor haemodynamics over time may be useful in patients with heart failure. This multicentre study assessed the feasibility of a system that has one sensor measuring absolute pressure and another measuring mixed venous oxygen saturation (SvO(2)). Both sensors were mounted on leads that were implanted in the right ventricle. METHODS: Twenty-one patients with heart failure (NYHA II-III) were included. Comparisons were made to right heart catheterizations at implant and at 2, 6 and 12 months thereafter. Patients underwent several haemodynamic provocations during the catheterizations. RESULTS: Overall, among functioning sensors, the IHM-1 values were highly correlated with reference values for all time points during all provocations, demonstrating high reproducibility and stability (r(2)=0.91, 0.79 and 0.78 for systolic, right ventricular diastolic and SvO(2), respectively). Although IHM-1 underestimated reference pressure values by 4.5 mmHg and SvO(2)by 1.6%, this difference was consistent across provocation and stable over 12 months of follow-up. Twelve of the 21 oxygen sensors failed to function and two pressure sensors had component failures. Preliminary analysis of long-term data revealed haemodynamic patterns that may be key indicators for therapeutic interventions. CONCLUSION: This multicentre feasibility study demonstrated the accuracy and stability of sensors implanted in the right ventricle. The IHM-1, using right ventricular pressures and SvO(2), with improved performance, might be useful in the study of pathophysiological mechanisms and treatment interventions in heart failure.

Adult↗

Survival, morbidity, and resource use of infants of 25 weeks' gestational age or less.

OBJECTIVE: The objective of this study was to examine survival, morbidity, and resource use in a large cohort of extremely preterm infants. STUDY DESIGN: We examined all (n = 754) neonatal intensive care unit admissions born at < or =25 weeks' gestation and inborn deliveries (n = 949) between 22 and 25 weeks' gestation at 17 Canadian neonatal intensive care units. RESULTS: The overall survival rate was 63%, with a range from 14% at 22 weeks' gestation to 76% at 25 weeks' gestation. There was a high incidence of chronic lung disease (33%-51%), > or =grade 3 intraventricular hemorrhage (0%-16%), necrotizing enterocolitis (0%-14%), > or =stage 3 retinopathy of prematurity (27%-55%), nosocomial infection (25%-39%), and multiple gestation (18%-46%). Extremely preterm infants comprise 4% of neonatal intensive care unit admissions but account for 22% of deaths, 20%-60% of major morbidities, 11% of patient days, and 10%-35% of major procedures. Outborn infants had a higher incidence of chronic lung disease, severe retinopathy of prematurity, and intraventricular hemorrhage. CONCLUSION: Extremely preterm infants have a high incidence of mortality and morbidity and consume disproportionate amounts of neonatal intensive care unit resources.

Canada↗

Multiple courses of antenatal corticosteroids: a systematic review and meta-analysis.

OBJECTIVE: To assess the effects of multiple courses of antenatal corticosteroids on perinatal and neonatal death and neonatal, infant, and maternal disease. METHODS: MEDLINE and Embase were searched for human studies published in English. Studies that compared multiple courses of antenatal corticosteroids versus a single course were included if they were published in full and were controlled for gestational age at birth. Meta-analyses (odds ratio and 95% confidence interval) were undertaken when possible. RESULTS: Eight observational studies were included. Selection bias was present in all studies. Multiple courses of antenatal corticosteroids were associated with a decreased risk of respiratory distress syndrome (odds ratio, 0.79; 95% confidence interval, 0.64 to 0.98) and patent ductus arteriosus (odds ratio, 0.56; 95% confidence interval, 0.35 to 0.90) and were associated with an increased risk of endometritis (odds ratio, 3.42; 95% confidence interval, 1.92 to 6.11). There was no significant effect on other neonatal and maternal outcomes. CONCLUSION: It is not possible to establish the true effects of multiple courses of antenatal corticosteroids by a review of the results of observational studies because of the effect of confounding variables. Randomized controlled trials are needed to address this important issue.

Adrenal Cortex Hormones↗

Management of monoamniotic twin pregnancies: a case series and systematic review of the literature.

OBJECTIVES: To review the experience of the University of Toronto Perinatal Complex, Ontario, Canada concerning antenatally diagnosed monoamniotic twin pregnancies; and to compare our results with cases reported in the literature with respect to antenatal surveillance and perinatal outcome. METHODS: A retrospective chart review of all twin gestations from 1993 to April 2000 was performed. A systematic review of the literature, 1966 to April 2000, of perinatal outcome in monoamniotic twin pregnancies was undertaken. SETTING: All monoamniotic twin gestations at the University of Toronto. RESULTS: Case-series: 25 prenatally diagnosed monoamniotic twin pregnancies were identified. Seven pregnancies were affected by fetal anomalies. One fetus died at 29 weeks. Neonatal complications occurred below 33 weeks of gestational age and were related to immaturity. Systematic review of the literature: 49 studies met our selection criteria and reported 88 cases diagnosed antenatally. Fourteen pregnancies were affected by major congenital anomalies. Twenty fetuses died after 24 weeks of gestation. Neonatal complications varied widely in severity and depended on gestational age at birth. The risk of intrauterine fetal death was 10% at the University of Toronto and 12% in the review of the literature. DISCUSSION: Our experience, the largest so far, suggests that regular fetal surveillance and appropriate steroid administration leads to a good perinatal outcome. The risk of fetal death (10%-12%) is lower than the previously quoted risk of 30%-70%. A careful review of obstetric interventions and further work examining outpatient surveillance of monoamniotic twin pregnancies are needed. The best treatment of monoamniotic twin pregnancies can only be determined by randomised trials.

Adolescent↗

Changes in stillbirth and infant mortality associated with increases in preterm birth among twins.

OBJECTIVE: To examine whether the recent substantial increase in preterm birth among twins has been associated with changes in fetal and infant mortality. DESIGN: Cohort study based on information in the linked live birth, stillbirth, and mortality databases of Statistics Canada. SETTING: Ten of 12 provinces and territories in Canada. PARTICIPANTS: All twin live births and stillbirths between 1985 and 1996, along with information on deaths during infancy (1985-1997). MAIN OUTCOME MEASURE: Fetal and infant mortality rates. RESULTS: The rate of preterm birth among twin live births increased significantly by 17% (95% confidence interval: 14%-20%) from 42.5% between 1985 and 1987 to 49.6% between 1994 and 1996. Overall, stillbirth rates among twins declined from 22.4 per 1000 total births in 1985 to 1987 to 18.8 per 1000 total births in 1994 to 1996. Among twin fetuses >/=34 weeks' gestation, stillbirth rates decreased from 9.5 per 1000 in 1985 to 1987 to 5.4 per 1000 fetuses at risk in 1994 to 1996. Infant mortality rates among twin live births declined substantially in all categories of gestational age above 24 weeks except for live births at 32 to 33 and 34 to 36 weeks' gestation. CONCLUSIONS: The recent increase in preterm birth among twins was associated with a substantial reduction in stillbirth rates at and near term gestation. Infant mortality rates declined concurrently, although the absence of a significant decrease in infant mortality among twin live births at 32 to 33 and 34 to 36 weeks' gestational age needs additional scrutiny.

Canada↗

Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants.

BACKGROUND: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight infants. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis does not begin until several months after birth. Administration of intravenous immunoglobulin provides IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemoluminescence. Intravenous immunoglobulin thus has the potential of preventing or altering the course of nosocomial infections. OBJECTIVES: To assess the effectiveness/safety of intravenous immunoglobulin (IVIG) administration (compared to placebo or no intervention) to preterm (< 37 weeks gestational age at birth) and/or low birth weight (LBW) (< 2500 g BW) infants in preventing nosocomial infections. SEARCH STRATEGY: Medline, Embase, Cochrane Library and Reference Update Databases were searched in November 1997 using keywords: immunoglobulin and infant-newborn and random allocation or controlled trial or randomized controlled trial (RCT). The reference lists of identified RCTs, personal files and Science Citation Index were searched. No language restrictions were applied. SELECTION CRITERIA: The criteria used to select studies for inclusion in this overview were: 1) DESIGN: RCTs in which administration of IVIG was compared to a control group that received a placebo or no intervention. 2) POPULATION: preterm (< 37 weeks gestational age) and/or LBW (<2500 g) infants. 3) INTERVENTION: IVIG for the prevention of bacterial/fungal infection during initial hospital stay (8 days or longer). (Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded as were studies in which the follow-up period was one week or less). 4) At least one of the following outcomes was reported: sepsis, any serious infection, death from all causes, death from infection, length of hospital stay, intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD). DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted information for each outcome reported in each study, and one researcher (AO) checked for any discrepancies and pooled the results. Relative risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effects model are reported. When a statistically significant RD was found the number needed to treat (NNT) was also calculated with 95% CIs. The results include all accepted studies in which the outcome of interest was reported. When statistically significant heterogeneity was found for an outcome, secondary (sensitivity) analyses were performed including only studies of the highest quality. MAIN RESULTS: Fifteen studies met inclusion criteria. These included 5,054 preterm and/or LBW infants and reported on at least one of the outcomes of interest for this systematic review. When all studies were combined there was a statistically significant reduction in sepsis, one or more episodes [RR 0.83 (95% CI 0.72, 0.97); RD -0.028 (95% CI -0.006, -0.051); NNT 36 (95% CI 20, 167)]. There was significant between-study heterogeneity. When, in a sensitivity analysis, the high quality studies were combined, the results remained significant [RR 0.78 (95% CI 0.62, 0.98); RD -0.031(95% CI -0.003, -0.059); NNT 32 (95% CI 17, 333]. For this analysis there was no statistically significant between-study heterogeneity. A statistically significant reduction was also found for any serious infection, one or more episodes, when all studies were combined [RR 0.85 (95% CI 0.75, 0. 95); RD -0.032 (95% CI -0.010, -0.054,); NNT 31 (95% CI 19, 100). There was statistically significant between-study heterogeneity. When, in a sensitivity analysis, the high quality studies were combined the results remained statistically significant [RR 0.80 (95% CI

Cross Infection↗

Inositol for respiratory distress syndrome in preterm infants.

BACKGROUND: Inositol is an essential nutrient required by human cells in culture for growth and survival. Inositol promotes maturation of several components of surfactant and may play a critical role in fetal and early neonatal life. OBJECTIVES: To assess the effectiveness/safety of supplementary inositol in preterm infants with RDS in reducing adverse neonatal outcomes. SEARCH STRATEGY: Medline, Embase, and Reference Update Databases were searched in August 1997 using key words: inositol and infant-newborn and random allocation or controlled trial or randomized trial (RCT). The reference lists of identified RCTs, personal files and Science Citation Index were searched. Unpublished additional information was obtained from the authors of one RCT published in abstract form. SELECTION CRITERIA: All randomized controlled trials of inositol supplementation to preterm infants with a control group that received a placebo or no intervention were included. Outcomes of interest were bronchopulmonary dysplasia (BPD), death, BPD or death, retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), and sepsis. DATA COLLECTION AND ANALYSIS: Data on neonatal outcomes were abstracted independently by the two researchers and any discrepancy was resolved through consensus. Revman was used for analysis of the data. MAIN RESULTS: Four reports of three RCTs were identified. One report was a duplicate publication. The outcome of death or bronchopulmonary dysplasia was reported in two trials, and was found to be significantly reduced (RR 0.56, 95% CI 0.42, 0.77; RD -0.215, 95% CI -0.323, -0.107). The outcome of death was reported in two trials and was found to be significantly reduced (RR 0.48, 95% CI 0.28, 0.80; RD -0.131, 95% CI -0.218, -0.043). Retinopathy of prematurity, stage 4 or needing therapy, was reported in two trials, and was found to be significantly reduced (RR 0.09, 95% CI 0.01, 0.67; RD -0.078, 95% CI -0.128, -0.027). Intraventricular hemorrhage, grade III-IV, was significantly decreased (RR 0.55, 95% CI 0.32, 0.95; RD -0.090, 95% CI -0.170, -0.010). Neither sepsis nor necrotizing enterocolitis outcomes were increased. When a secondary analysis was done excluding a study published in abstract form, the results differed only in that there was a significant reduction in retinopathy of prematurity, any stage (RR 0.53, 95% CI 0.29, 0.97; RD -0.082, 95% CI -0.159,-0.005). REVIEWER'S CONCLUSIONS: Inositol supplementation results in statistically significant and clinically important reductions in important short-term adverse neonatal outcomes. A multi-center RCT of appropriate size is justified to confirm these findings.

Dietary Supplements↗

Massage for promoting growth and development of preterm and/or low birth-weight infants.

BACKGROUND: It has been argued that infants in Neonatal Intensive Care Units are subject both to a highly stressful environment - continuous, high-intensity noise and bright light - and to a lack of the tactile stimulation that they would otherwise experience in the womb or in general mothering care. As massage seems to both decrease stress and provide tactile stimulation, it has been recommended as an intervention to promote growth and development of preterm and low-birth weight infants. OBJECTIVES: To determine whether preterm and / or low birth-weight infants exposed to massage experience improved weight gain and earlier discharge compared to infants receiving standard care; to determine whether massage has any other beneficial or harmful effects on this population. SEARCH STRATEGY: Databases were searched using the term 'massage', 'touch' or 'tactile stimulation' with 'infant - newborn', 'infant - premature' and 'infant - low birth weight'. The main databases searched were those of the Cochrane Collaboration Field in Complementary Medicine and the Neonatal Collaborative Review Group. SELECTION CRITERIA: Randomised trials in which infants with gestational age at birth < 37 weeks or weight at birth < 2500g received systematic tactile stimulation by human hands. At least one outcome assessing weight gain, length of stay, behaviour or development must be reported. DATA COLLECTION AND ANALYSIS: Data extracted from each trial were baseline characteristics of sample, weight gain, length of stay and behavioural and developmental outcomes. Physiological and biochemical outcomes were not recorded. Data were extracted by three reviewers independently. Statistical analysis was conducted using the standard Cochrane Collaboration methods. MAIN RESULTS: Massage interventions improved daily weight gain by 5g (95% CI 3.5, 6.7g). There is no evidence that gentle, still touch is of benefit (increase in daily weight gain -0.2g; 95% CI -2.4, 1.9g). Massage interventions also appeared to reduce length of stay by 4.6 days (95% CI 2.6, 6.6) though there are methodological concerns about the blinding of this outcome. There was also some evidence that massage interventions have a slight, positive effect on postnatal complications and weight at 4 - 6 months. However, serious concerns about the methodological quality of the included studies, particularly with respect to selective reporting of outcomes, weaken credibility in these findings. REVIEWER'S CONCLUSIONS: Evidence that massage for preterm infants is of benefit for developmental outcomes is weak and does not warrant wider use of preterm infant massage. Where massage is currently provided by nurses, consideration should be given as to whether this is a cost-effective use of time. Future research should assess the effects of massage interventions on clinical outcome measures, such as medical complications or length of stay, and on process-of-care outcomes, such as care-giver or parental satisfaction.

Growth↗

Lidocaine-prilocaine cream for analgesia during circumcision in newborn boys.

BACKGROUND: Neonates routinely undergo tissue-damaging interventions as part of medical treatment. The skin is the site of noxious stimulation for many procedures, including circumcision. EMLA (eutectic mixture of local anesthetics) penetrates intact skin and has the potential to reduce pain associated with circumcision. OBJECTIVES: To determine the effectiveness of EMLA compared to placebo or no treatment as an analgesic for circumcision in male newborns. SEARCH STRATEGY: The guidelines of the Cochrane Neonatal Review Group were followed. No language restrictions were applied. Three reviewers (AT, KO, AO) agreed through a consensus process on the inclusion of a specific study. SELECTION CRITERIA: Randomized controlled trials assessing the efficacy/effectiveness of EMLA to prevent circumcision associated pain. Behavioral and physiological outcome data were accepted for efficacy/effectiveness. DATA COLLECTION AND ANALYSIS: Data abstracted from each report included gestational age at birth, timing and dosage regimen of EMLA, control group treatment and outcomes. Abstracted data were verified by the three investigators (AT, KO, AO). MAIN RESULTS: During the different stages of the surgical procedure for circumcision, the increase in heart rate was 12 - 27 beats per minute less for the EMLA group compared to placebo. In a single study, neonates treated with EMLA showed a higher oxygen saturation. Although the data from the three studies could not be combined, crying during circumcision was reported as less in the EMLA treated groups. In two studies, facial action was lower in the EMLA treated groups compared to placebo. REVIEWER'S CONCLUSIONS: EMLA reduces pain response during circumcision in newborn male infants. Other potentially more effective forms of analgesia for circumcision (such as dorsal penile nerve block, ring block) should be subjected to systematic reviews.

Anesthetics, Local↗