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Although oxygen is probably the most common therapy delivered to small or sick newborns in the past 75 years, what constitutes appropriate oxygenation for these infants remains highly controversial. The lack of direct evidence, in the form of randomised trials, of the effects of different oxygen levels on meaningful, long-term outcomes has fuelled this controversy and contributed to the significant variation in practice currently seen. Conclusions drawn from the existing evidence regarding oxygen saturation levels for preterm infants include that retinopathy of prematurity rates may be reduced if lower saturation ranges are targeted in the early weeks of life. There is, however, no recent, good quality, trial information that has directly addressed this question. Retinopathy outcomes may also be improved if oxygen saturation is targeted higher in a subset of preterm infants with more severe eye disease in the post-acute phase. There is now direct evidence, from randomised trials, that routine higher oxygen saturation targeting in the chronic phase confers no short- or long-term growth or development benefits. Evidence is now mounting regarding the adverse pulmonary sequelae associated with routine higher, and thus longer, oxygen exposure. Information regarding oxygen saturation levels and early mortality is inconclusive. The major unanswered question that requires urgent resolution is the important long-term effects of targeting lower versus higher oxygen saturation ranges during the first days/weeks of a preterm infant's life. Such an important clinical question can only be answered rigorously and definitively using the randomised trial methodology. [ABSTRACT FROM AUTHOR]

Background Cancer patients want access to reliable information about currently recruiting clinical trials. Patients and methods Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist–patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Results Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P = 0.08). The mean consultation length in both groups was 29 min (P = 0.69). The proportion consenting to a trial was 10% in both groups (P = 0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P = 0.03) but decisional conflict scores were similar (mean score 42 versus 43, P = 0.83). Conclusions Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation. [ABSTRACT FROM PUBLISHER]

Objective: To compare the effect of two volumes of enteral feeds on postnatal growth in infants born before 30 weeks gestation.Methodology: Fifty-four infants, less than 30 weeks gestational age, who reached full enteral feeds were randomized to remain on 150 mL/kg per day (150 group) or increase to 200 mL/kg per day (200 group). The primary outcome measure was growth at 35 weeks corrected gestational age (CGA).Results: There were no statistically significant differences in demographic or clinical parameters between the study groups at commencement of the study, although there was a trend for infants in the 150 group to be lighter (895 g vs 1020 g, P = 0.27). Milk intakes were increased in 43% of the infants in the 150 group, whereas 54% of the infants in the 200 group required reduced intakes. Infants in the 200 group had greater daily weight gains (16.7 g/kg per day vs 15.2 g/kg per day, P = 0.047) and at 35 weeks CGA were heavier (2020 g vs 1885 g, P = 0.014) and had a greater arm fat area (282 mm2 vs 218 mm2, P = 0.009). There was no difference in length or head circumference at 35 weeks CGA, and no difference in any growth parameter at 1 year of age. Morbidity was not different between the groups.Conclusions: The individual milk volume requirements for adequate weight gain without significant adverse effects vary between 150 and 200 mL/kg per day in extremely premature infants. For many infants in both groups, the assigned target volume was not appropriate. Increased milk intakes (and therefore higher caloric and mineral intakes) are associated with increased daily weight gains and a greater weight at 35 weeks CGA. The weight gain may be due to an increase in fat deposition. [ABSTRACT FROM AUTHOR]

Background: For prospective meta-analyses (PMAs), eligible studies are identified, and the PMA hypotheses, selection criteria, and analysis methods are pre-specified before the results of any of the studies are known. This reduces publication bias and selective outcome reporting and provides a unique opportunity for outcome standardisation/harmonisation. We conducted a world-first PMA of four trials investigating interventions to prevent early childhood obesity. The aims of this study were to quantitatively analyse the effects of prospective planning on variations across trials, outcome harmonisation, and the power to detect intervention effects, and to derive recommendations for future PMA.Methods: We examined intervention design, participant characteristics, and outcomes collected across the four trials included in the EPOCH PMA using their registration records, protocol publications, and variable lists. The outcomes that trials planned to collect prior to inclusion in the PMA were compared to the outcomes that trials collected after PMA inclusion. We analysed the proportion of matching outcome definitions across trials, the number of outcomes per trial, and how collaboration increased the statistical power to detect intervention effects.Results: The included trials varied in intervention design and participants, this improved external validity and the ability to perform subgroup analyses for the meta-analysis. While individual trials had limited power to detect the main intervention effect (BMI z-score), synthesising data substantially increased statistical power. Prospective planning led to an increase in the number of collected outcome categories (e.g. weight, child's diet, sleep), and greater outcome harmonisation. Prior to PMA inclusion, only 18% of outcome categories were included in all trials. After PMA inclusion, this increased to 91% of outcome categories. However, while trials mostly collected the same outcome categories after PMA inclusion, some inconsistencies in how the outcomes were measured remained (such as measuring physical activity by hours of outside play versus using an activity monitor).Conclusion: Prospective planning led to greater outcome harmonisation and greater power to detect intervention effects, while maintaining acceptable variation in trial designs and populations, which improved external validity. Recommendations for future PMA include more detailed harmonisation of outcome measures and careful pre-specification of analyses to avoid research waste by unnecessary over-collection of data. [ABSTRACT FROM AUTHOR]

Background: The preferred timing of umbilical-cord clamping in preterm infants is unclear.Methods: We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births.Results: Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities.Conclusions: Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088 .). [ABSTRACT FROM AUTHOR]

Background: Risk prediction models may be valuable to identify women at risk of pre-eclampsia to guide aspirin prophylaxis in early pregnancy.Objective: To assess the performance of 'simple' risk models for pre-eclampsia that use routinely collected maternal characteristics; compare with 'specialised' models that include specialised tests; and to guideline recommended decision rules.Search Strategy: MEDLINE, Embase and PubMed were searched to June 2014.Selection Criteria: We included studies that developed or validated pre-eclampsia risk models using maternal characteristics with or without specialised tests and reported model performance.Data Collection and Analysis: We extracted data on study characteristics; model predictors, validation and performance including area under the curve (AUC), sensitivity and specificity.Main Results: We identified 29 studies that developed 70 models including 22 simple models. Studies included 151-9149 women with a pre-eclampsia prevalence of 1.2-9.5%. No single predictor was included in all models. Four simple models were externally validated, with a model using parity, pre-eclampsia history, race, chronic hypertension and conception method to predict early-onset pre-eclampsia achieving the highest AUC (0.76, 95% CI 0.74-0.77). Nine studies comparing simple versus specialized models in the same population reported AUC favouring specialised models. A simple model achieved fewer false positives than a guideline recommended risk factor list, but sensitivity to classify risk for aspirin prophylaxis was not assessed.Conclusion: Validated simple pre-eclampsia risk models demonstrate good risk discrimination that can be improved with specialised tests. Further research is needed to determine their clinical value to guide aspirin prophylaxis compared with decision rules.Tweetable Abstract: Pre-eclampsia risk models using maternal factors show good risk discrimination to guide aspirin prophylaxis. [ABSTRACT FROM AUTHOR]

Objective: This study aims to explore the current attitudes of Australian neonatologists and nurses towards the resuscitation of extremely preterm infants.Methodology: An anonymous questionnaire regarding resuscitation of infants of less than 28 weeks gestation was sent to all neonatologists and three registered nurses in each perinatal centre in Australia.Results: One hundred and thirty-three questionnaires were sent. A return rate of 93% and 73% was obtained from neonatologists and nurses, respectively. Twenty-two per cent of neonatologists would 'occasionally' resuscitate at 22 weeks while none of the nurses would. A considerable proportion of neonatologists (23%) but only a few nurses (6%) would 'quite often' resuscitate 23-week infants. The majority of neonatologists (85%) and nurses (88%) would 'almost always' resuscitate 24 week infants. More than half of the respondents would 'occasionally' resuscitate a 400-499 g infant and most would resuscitate infants weighing more than 500 g. Clinicians were not as optimistic of long-term outcome as they were for survival. Typically, only 52% of neonatologists and 38% of nurses thought babies of 25 weeks gestation had a greater than 50% chance of survival without major handicap. Parental wishes and the presence of congenital abnormalities were major influences on decision to resuscitate. Hypothetically, most respondents, more doctors than nurses, would consider initiating resuscitation without parental consent at a median gestation of 25 weeks.Conclusions: The majority of Australian clinicians would resuscitate at a gestation of 24 weeks or greater or at a birth weight of over 500 g despite conservative estimates of intact survival. This survey has brought to light the importance of communication with parents prior to extreme premature birth. [ABSTRACT FROM AUTHOR]

An abstract of the article "Antiplatelet therapy before or after 16 weeks' gestation for preventing pre-eclampsia: an individual participant data meta-analysis," by S. Meher and colleagues is presented.