Bmc Pediatr
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Randomized Controlled Trial Multicenter Study Comparative Study
Long-term safety of mometasone furoate administered via a dry powder inhaler in children: Results of an open-label study comparing mometasone furoate with beclomethasone dipropionate in children with persistent asthma.
To assess the long-term pediatric safety of 2 doses of mometasone furoate administered via a dry powder inhaler (MF-DPI) for mild-to-moderate persistent asthma and compare them with that of beclomethasone dipropionate administered via a metered dose inhaler (BDP-MDI) in the treatment of persistent asthma. Both MF-DPI doses tested are twice the approved pediatric dosage of 100 microg once-daily (QD) for children aged 4-11 years. ⋯ Both MF-DPI doses were well tolerated, with no unusual or unexpected adverse events or safety concerns, and had a similar adverse event profile to that of BDP-MDI 168 microg BID.
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Randomized Controlled Trial Multicenter Study
Maximising engagement, motivation and long term change in a Structured Intensive Education Programme in Diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE).
This trial aims to evaluate effective delivery and cost effectiveness of an innovative structured psycho-educational programme (CASCADE) for young people and their families living with diabetes. The increase in numbers of people being diagnosed with diabetes is posing a challenge for both the UK and the rest of the world. The peak age for diagnosis is between 10 and 14 years of age. There is clear evidence that improved diabetes control from diagnosis in childhood can reduce the incidence and progression of long-term complications. However, despite the development of improved insulin regimens and delivery methods, the overall metabolic control in children and adolescents has improved little in the UK in the past decade. Therefore there is a need for novel interventions and health delivery mechanisms aimed at young people and their families to help improve control and reduce complications, illness burden and costs to the NHS. ⋯ The trial will be run by independent research and service delivery teams and supervised by a trial steering committee. A data monitoring and ethics committee has been put in place to monitor the trial and recommend stopping/continuation according to a Peto-Haybittle rule. The trial will be conducted according to the principles of MRC Good Clinical Practice (GCP) Guidelines and CTRU Phase III Trial Standard Operating procedures.
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Multicenter Study Comparative Study
Incidence and risk factors of hospitalization for bronchiolitis in preterm children: a retrospective longitudinal study in Italy.
Bronchiolitis is a distressing, potentially life-threatening respiratory condition that affects infants. We evaluated the incidence and risk factors of hospitalization for broncholitis in preterm infants (i.e., a gestational age of <36 weeks) born between 2000 and 2006, and the use and impact of Palivizumab, a monoclonal antibody that in randomized clinical trials has been shown to lessen the severity of RSV-related bronchiolitis. ⋯ In Italy the incidence of hospitalization for bronchiolitis, and its associated risk factors, are similar to that found in other countries. Although Palivizumab use is associated with the most important characteristics of severe prematurity, other aspects of its non-use in children with congenital heart disease, the age and the birth country of the mother suggest the need for public health measures that can reduce these health disparities. Finally, the estimated effectiveness of Palivizumab in routine practice, although not significant, confirms the results of previous clinical trials, but its impact on modifying the temporal trend in this population is still negligible.
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Randomized Controlled Trial Multicenter Study
The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial.
A hypoxic-ischaemic insult occurring around the time of birth may result in an encephalopathic state characterised by the need for resuscitation at birth, neurological depression, seizures and electroencephalographic abnormalities. There is an increasing risk of death or neurodevelopmental abnormalities with more severe encephalopathy. Current management consists of maintaining physiological parameters within the normal range and treating seizures with anticonvulsants. Studies in adult and newborn animals have shown that a reduction of body temperature of 3-4 degrees C after cerebral insults is associated with improved histological and behavioural outcome. Pilot studies in infants with encephalopathy of head cooling combined with mild whole body hypothermia and of moderate whole body cooling to 33.5 degrees C have been reported. No complications were noted but the group sizes were too small to evaluate benefit. ⋯ Combined rate of mortality and severe neurodevelopmental impairment in survivors at 18 months of age. Neurodevelopmental impairment will be defined as any of:* Bayley mental developmental scale score less than 70* Gross Motor Function Classification System Levels III - V* Bilateral cortical visual impairments
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Multicenter Study
Evaluation of procalcitonin for diagnosis of neonatal sepsis of vertical transmission.
The results of recent studies suggest the usefulness of PCT for early diagnosis of neonatal sepsis, with varying results. The aim of this prospective multicenter study was to determine the behavior of serum PCT concentrations in both uninfected and infected neonates, and to assess the value of this marker for diagnosis of neonatal sepsis of vertical transmission. ⋯ Serum PCT was moderately useful for the detection of sepsis of vertical transmission, and its reliability as a maker of bacterial infection requires specific cutoff values for each evaluation point over the first 48 h of life.