Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial.

BACKGROUND: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) has emerged as an urgent global health threat and is by the World Health Organization ranked as priority 1 among pathogens in need of new treatment. Studies have shown high mortality in Tanzanian children with ESBL-E infections. Gut colonization of ESBL-E, which is a potential risk factor of ESBL-E infections, is reported to be very high among children in Tanzania. Probiotics may potentially reduce gut colonization of multidrug-resistant bacteria. However, there is limited data on whether probiotics may reduce ESBL-E carriage in infants. The ProRIDE Trial aims to evaluate whether the use of probiotics can reduce morbidity and mortality among infants in Haydom, Tanzania, and whether this effect is associated with a reduction in ESBL-E colonization and/or infections. METHODS/DESIGN: This large randomized double-blinded placebo-controlled trial aims to recruit 2000 newborn infants at Haydom Lutheran Hospital and the surrounding area in the period of November 2020 to November 2021. Participants will be enrolled from days 0 to 3 after birth and randomized to receive probiotics or placebo for 4 weeks. Participants will be followed-up for 6 months, during which three visits will be made to collect clinical and demographic information, as well as rectal swabs and fecal samples which will be subjected to laboratory analysis. The primary composite outcome is the prevalence of death and/or hospitalization at 6 months of age. DISCUSSION: As the use of probiotics may give a more favorable gut composition, and thereby improve health and reduce morbidity and mortality, the results may have implications for future therapy guidelines in Africa and internationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT04172012. Registered on November 21, 2019.

Comparison of three dehydration scales showed that they were of limited or no value for assessing small children with acute diarrhoea.

AIM: We explored the diagnostic accuracy of the clinical dehydration scale (CDS), the World Health Organization (WHO) scale and the Gorelick scale for assessing dehydration in children admitted to a Tanzanian referral hospital. METHODS: This was a prospective, observational study, carried out from April 2015 to January 2017 on children aged one month to five years admitted to the hospital with acute diarrhoea lasting less than five days. Before rehydration therapy, each patient's weight was recorded and the degree of dehydration was assessed based on the three scales. The reference standard was the percentage weight change between admission and discharge. The main outcomes were the sensitivity, specificity and positive and negative likelihood ratios (LRs) of the scales. RESULTS: Data from 124 eligible patients were available. The CDS showed limited value for ruling in cases with some dehydration (LR 1.9, 95% confidence interval 1.1-2.8), but was of no value in assessing no and moderate to severe dehydration. The WHO and Gorelick scales were of no value in evaluating any degree of dehydration. CONCLUSION: The WHO and Gorelick dehydration scales were no use for assessing dehydration in small children, and the CDS was of limited use for predicting cases with some dehydration.