Comparison of BiliCocoon phototherapy with overhead phototherapy in hyperbilirubinemic neonates. A randomized clinical trial.

BACKGROUND: Around 2-6% of term or late preterm neonates receive phototherapy for hyperbilirubinemia. Standard treatment today is overhead phototherapy. A new device has been developed, the BiliCocoon, where the neonates are "wrapped" presumably making them more comfortable. The aim was to compare the efficacy and performance of the BiliCocoon with overhead LED phototherapy. METHODS: A randomized open-label multicenter trial in three Danish neonatal units. Healthy hyperbilirubinemic neonates, gestational age ≥33 weeks and postnatal age 24 h to 14 days were randomized to 24 hours' of treatment with BiliCocoon or overhead blue LED phototherapy with an equal level of irradiance. A mixed effect model with random effect by center was used to compare the percentage decrease in total serum bilirubin (TSB) between the treatments. RESULTS: Totally 83 neonates were included. Mean TSB reduction in the BiliCocoon group (N = 42), adjusted for baseline TSB, was significantly lower than in the overhead LED group (N = 41), 29% vs. 38% (p-value < 0.01). Overall difference in temperature by treatment (BiliCocoon vs overhead) was 0.70 [0.37; 1.02] °C, p-value < 0.01. CONCLUSION: Bilirubin reducing efficacy of BiliCocoon was lower than that of overhead phototherapy, but it was sufficient for nearly all neonates during 24 hours of treatment. IMPACT: The BiliCocoon has a bilirubin reducing efficacy, sufficient for almost all neonates during 24 hours of phototherapy. The BiliCocoon does not have an equal bilirubin reducing efficacy as overhead phototherapy. The duration of light exposure was longer for the neonates treated in the BiliCocoon. A few neonates can be exclusively breastfed in the BiliCocoon throughout the treatment. The reason for stopping breastfeeding in the BiliCocoon was most often, that the neonates developed hyperthermia.

Municipal offers and principles for substitution treatment for abuse and addiction to opioids.

Opioid use disorders can be treated with psychosocial interventions which aim to increase quality of life and minimize problems maintaining drug use. In addition, pharmacological treatment with opioid maintenance therapy (OMT) can help minimize morbidity and mortality. The principle for OMT is substituting to another opioid with a more favourable pharmacological profile, primarily buprenorphine or methadone. The first choice is buprenorphine in combination with naloxone. The aim of this review is to summarize current principles for handling patients in OMT.

Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial.

OBJECTIVE: To assess the effect of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care identified with the validated Eating Validation Scheme (EVS). METHODS: An 11 wk cluster randomized trial with a home-care (3 clusters) or nursing home (3 clusters) setting as the unit of randomization. Before starting the study, a train-the-trainer course was performed to educate the nutrition coordinators. In addition to the nutrition coordinator, the participants assigned to the intervention group strategy received multidisciplinary nutrition support. Focus was on treatment of the potentially modifiable nutritional risk factors identified with the EVS, by involving the physiotherapist, registered dietitian, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system. Outcome parameters were quality of life (by means of EuroQol-5D-3L), physical performance (30-seconds chair stand), nutritional status (weight and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (participants from home-care), and mortality. RESULTS: Respectively, 55 (46 from 2 home-care clusters) and 40 (18 from 1 home-care cluster) were identified with the EVS and comprised the intervention and control group. A difference after 11 wk in quality of life (0.758 [0.222] versus 0.534 [0.355], P = 0.001), 30-seconds chair stand (47% versus 17% improved, P = 0.005) and oral care (1.1 [0.3] versus 1.3 [0.5], P = 0.021) was observed. There was a almost significant difference in mortality (2% versus 13%, P = 0.079). CONCLUSIONS: Multidisciplinary nutritional support in older adults in nursing home and home-care could have a positive effect on quality of life, muscle strength, and oral care.

Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

BACKGROUND: Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition. Hence a structured and multidisciplinary approach, focusing on the nutritional risk factors and involving e.g. dieticians, occupational therapists, and physiotherapist, may be necessary to achieve benefits. Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. METHODS: An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care, identified by screening with the Eating validation Scheme. Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator, the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support. Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening, by involving physiotherapist, registered dietician, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (for participants from home-care), use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary support.Furthermore, interviews with nursing home and home-care management, nursing staff and nutrition coordinators in both the control and intervention groups, participants in the intervention group and the involved multidisciplinary team will be performed. CONCLUSION: In this study we will evaluate in a randomized controlled trial whether multidisciplinary nutritional support is cost-effective, in undernourished older adults in home-care and nursing home and contribute to important research. TRIAL REGISTRATION: ClinicalTrials.gov 2013 NCT01873456.

Epidemiology and population structure of Staphylococcus aureus in various population groups from a rural and semi urban area in Gabon, Central Africa.

Little data is available on the epidemiology of Staphylococcus aureus in Africa. In the present study we aim at characterizing the population structure of S. aureus in healthy subjects from a rural and a semi-urban area in Lambaréné, Gabon as well as in hospital staff and inpatients. In total, 500 subjects were screened for S. aureus colonization of the nares, axillae and inguinal region. Overall, 146 (29%) were positive. We found 46 different spa types. The most frequent spa types were t084 (35%) and the agr II was the most prevalent subtype of the accessory gene regulator (56%, n=82). Five isolates (3%) were methicillin resistant S. aureus (MRSA). Carriage rates of S. aureus in Gabon are comparable to developed countries. MRSA is for the first time described and could pose a significant health threat in this region with limited access to microbiological laboratory facilities and to adequate antimicrobial agents.

Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial.

BACKGROUND: The RTS,S/AS01(E) candidate malaria vaccine is being developed for immunisation of infants in Africa through the expanded programme on immunisation (EPI). 8 month follow-up data have been reported for safety and immunogenicity of RTS,S/AS01(E) when integrated into the EPI. We report extended follow-up to 19 months, including efficacy results. METHODS: We did a randomised, open-label, phase 2 trial of safety and efficacy of the RTS,S/AS01(E) candidate malaria vaccine given with EPI vaccines between April 30, 2007, and Oct 7, 2009, in Ghana, Tanzania, and Gabon. Eligible children were 6-10 weeks of age at first vaccination, without serious acute or chronic illness. All children received the EPI diphtheria, tetanus, pertussis (inactivated whole-cell), and hepatitis-B vaccines, Haemophilus influenzae type b vaccine, and oral polio vaccine at study months 0, 1, and 2, and measles vaccine and yellow fever vaccines at study month 7. Participants were randomly assigned (1:1:1) to receive three doses of RTS,S/AS01(E) at 6, 10, and 14 weeks (0, 1, 2 month schedule) or at 6 weeks, 10 weeks, and 9 months (0, 2, 7 month schedule) or placebo. Randomisation was according to a predefined block list with a computer-generated randomisation code. Detection of serious adverse events and malaria was by passive case detection. Antibodies against Plasmodium falciparum circumsporozoite protein and HBsAg were monitored for 19 months. This study is registered with ClinicalTrials.gov, number NCT00436007. FINDINGS: 511 children were enrolled. Serious adverse events occurred in 57 participants in the RTS,S/AS01(E) 0, 1, 2 month group (34%, 95% CI 27-41), 47 in the 0, 1, 7 month group (28%, 21-35), and 49 (29%, 22-36) in the control group; none were judged to be related to study vaccination. At month 19, anticircumsporozoite immune responses were significantly higher in the RTS,S/AS01(E) groups than in the control group. Vaccine efficacy for the 0, 1, 2 month schedule (2 weeks after dose three to month 19, site-adjusted according-to-protocol analysis) was 53% (95% CI 26-70; p=0·0012) against first malaria episodes and 59% (36-74; p=0·0001) against all malaria episodes. For the entire study period, (total vaccinated cohort) vaccine efficacy against all malaria episodes was higher with the 0, 1, 2 month schedule (57%, 95% CI 33-73; p=0·0002) than with the 0, 1, 7 month schedule (32% CI 16-45; p=0·0003). 1 year after dose three, vaccine efficacy against first malaria episodes was similar for both schedules (0, 1, 2 month group, 61·6% [95% CI 35·6-77·1], p<0·001; 0, 1, 7 month group, 63·8% [40·4-78·0], p<0·001, according-to-protocol cohort). INTERPRETATION: Vaccine efficacy was consistent with the target put forward by the WHO-sponsored malaria vaccine technology roadmap for a first-generation malaria vaccine. The 0, 1, 2 month vaccine schedule has been selected for phase 3 candidate vaccine assessment. FUNDING: Program for Appropriate Technology in Health Malaria Vaccine Initiative; GlaxoSmithKline Biologicals.