Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial

BACKGROUND: Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects. METHODS: In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP; 250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age. RESULTS: In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had > or =1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%]; P=.06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%; P=.36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated. CONCLUSIONS: The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies.TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00167843.     

UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation: follow-up to age 4 years

Extracorporeal membrane oxygenation (ECMO) is a supportive intensive-care technique used for babies with acute respiratory failure. We examined morbidity at age 4 years in surviving children recruited to the UK Collaborative ECMO Trial, and provide long-term data on ECMO support compared with contemporary conventional care. The neonatal ECMO policy resulted in improved survival and a favourable outcome. We therefore advocate the safety and efficacy of this intervention.     

Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial

Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG (ATCC 53103), reduces incidence of atopic eczema in at-risk children during the first 2 years of life (infancy). We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years. Atopic disease was diagnosed on the basis of a questionnaire and a clinical examination. 14 of 53 children receiving lactobacillus had developed atopic eczema, compared with 25 of 54 receiving placebo (relative risk 0.57, 95% CI 0.33-0.97). Skin prick test reactivity was the same in both groups: ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive. Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy.     

Clarithromycin in the treatment of RSV bronchiolitis: a double-blind, randomised, placebo-controlled trial.

Respiratory syncytial virus (RSV) bronchiolitis is the most common lower respiratory tract infection in infancy. To date, there is no effective therapy for RSV bronchiolitis. In order to investigate the efficacy of clarithromycin in the treatment of RSV bronchiolitis, the present authors conducted a randomised, double-blind, placebo-controlled trial comparing clarithromycin with placebo in 21 infants with a diagnosis of RSV bronchiolitis. The infants were randomised to receive clarithromycin or placebo daily for 3 weeks. Levels of interleukin (IL)-4, IL-8, eotaxin, and interferon-gamma were determined in plasma, before and after treatment, using ELISA. Six months after treatment, parents were surveyed as to whether their child had experienced wheezing within the previous 6 months. Treatment with clarithromycin was associated with a statistically significant reduction in the length of hospital stay, the duration of need for supplemental oxygen and the need for beta(2)-agonist treatment. There were significant decreases in plasma IL-4, IL-8 and eotaxin levels after 3 weeks of treatment with clarithromycin. Readmission to the hospital within 6 months after discharge was significantly lower in the clarithromycin group. In conclusion, clarithromycin has statistically significant effects on the clinical and laboratory findings in respiratory syncytial virus bronchiolitis. Therefore, clarithromycin treatment may be helpful in reducing the short-term effects of respiratory syncytial virus bronchiolitis.