Summary Background Fetal lower urinary tract obstruction (LUTO) is associated with high perinatal and long-term childhood mortality and morbidity. We aimed to assess the effectiveness of ...vesicoamniotic shunting for treatment of LUTO. Methods In a randomised trial in the UK, Ireland, and the Netherlands, women whose pregnancies with a male fetus were complicated by isolated LUTO were randomly assigned by a central telephone and web-based randomisation service to receive either the intervention (placement of vesicoamniotic shunt) or conservative management. Allocation could not be masked from clinicians or participants because of the invasive nature of the intervention. Diagnosis was by prenatal ultrasound. The primary outcome was survival of the baby to 28 days postnatally. All primary analyses were done on an intention-to-treat basis, but these results were compared with those of an as-treated analysis to investigate the effect of a fairly large proportion of crossovers. We used Bayesian methods to estimate the posterior probability distribution of the effectiveness of vesicoamniotic shunting at 28 days. The study is registered with the ISRCTN Register, number ISRCTN53328556. Findings 31 women with singleton pregnancies complicated by LUTO were included in the trial and main analysis, with 16 allocated to the vesicoamniotic shunt group and 15 to the conservative management group. The study closed early because of poor recruitment. There were 12 livebirths in each group. In the vesicoamniotic shunt group one intrauterine death occurred and three pregnancies were terminated. In the conservative management group one intrauterine death occurred and two pregnancies were terminated. Of the 16 pregnancies randomly assigned to vesicoamniotic shunting, eight neonates survived to 28 days, compared with four from the 15 pregnancies assigned to conservative management (intention-to-treat relative risk RR 1·88, 95% CI 0·71–4·96; p=0·27). Analysis based on treatment received showed a larger effect (3·20, 1·06–9·62; p=0·03). All 12 deaths were caused by pulmonary hypoplasia in the early neonatal period. Sensitivity analysis in which non-treatment-related terminations of pregnancy were excluded made some slight changes to point estimates only. Bayesian analysis in which the trial data were combined with elicited priors from experts suggested an 86% probability that vesicoamniotic shunting increased survival at 28 days and a 25% probability that it had a large, clinically important effect (defined as a relative increase of 55% or more in the proportion of neonates who survived). There was substantial short-term and long-term morbidity in both groups, including poor renal function—only two babies (both in the shunt group) survived to 2 years with normal renal function. Seven complications occurred in six fetuses from the shunt group, including spontaneous ruptured membranes, shunt blockage, and dislodgement. These complications resulted in four pregnancy losses. Interpretation Survival seemed to be higher in the fetuses receiving vesicoamniotic shunting, but the size and direction of the effect remained uncertain, such that benefit could not be conclusively proven. Our results suggest that the chance of newborn babies surviving with normal renal function is very low irrespective of whether or not vesicoamniotic shunting is done. Funding UK National Institute of Health Research, Wellbeing of Women, Hannah Eliza Guy Charity (Birmingham Children's Hospital Charity).
Abstract Purpose This trial evaluates implementation of critical care outreach in a middle-income country. Materials and Methods Critical care outreach delivered by a team of intensive care nurses ...was implemented across general hospital wards in an Iranian university hospital. The order of implementation was randomised with wards stratified by predicted mortality rates. Effectiveness was evaluated using a stepped wedge cluster randomised controlled trial design, comparing outcomes between patients admitted before and after implementation. The primary outcomes were in-hospital mortality and cardiopulmonary resuscitation. A nested qualitative study explored challenges to implementation and contextualised the trial outcomes. Results Between July 2010 and December 2011, 13 wards were sequentially randomised to implement the critical care outreach: 7802 patients were admitted before implementation and 10 880 after implementation. There were 370 deaths (4.74%) among patients admitted before implementation and 384 deaths (3.53%) after implementation. Adjusting for clustering and temporal trends, the odds ratio for mortality was 1.03 (95% CI: 0.68–1.53). Results for other outcomes were broadly similar. Focus groups revealed a lack of endorsement of the intervention by management and ward nurses. Conclusions This pragmatic evaluation of critical care outreach in a middle income country did not show a reduction in mortality or other outcomes.
Objective To investigate the association between severity of impairment and gestational age in unilateral and bilateral spastic cerebral palsy, and to determine whether the influence of gestational ...age is independent of deviations from optimal birth weight. Study design The study group was a United Kingdom cohort of 4772 cases of spastic cerebral palsy born between 1960 and 1997, with information on birth demographics and severity of impairment. Generalized additive models were used to determine the proportions of cases severely impaired, by gestational age, and to determine whether gestational age or deviations from optimal birth weight better predicts severity of impairment. Results For unilateral spastic cerebral palsy, the proportions of severe impairments did not vary with gestational age. In contrast, for bilateral spastic cerebral palsy, the proportions of severe motor or cognitive impairments increased with increasing gestational age (e.g., from 20% to 50% between weeks 30 and 40 for cognitive impairment). For spastic cerebral palsy, gestational age is at least as good as deviation from optimal birth weight in predicting severity. Conclusions The severity of impairment increases with increasing gestational age in bilateral spastic cerebral palsy. This suggests differing etiologies in term and preterm infants and supports the theory that the developing brain is better able to compensate after a cerebral insult.
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