scholarly journals The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

2019 ◽  
Author(s):  
Jane Awiti Odhiambo Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Alexandra Czerniewska ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Infant Food ◽  
Food Hygiene ◽  
Randomized Controlled ◽  
Hygiene Intervention ◽  
Enteric Infections ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, especially in low-income urban settings. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targets four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria ( Enterococcus ) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the extension system can improve the health of young children.

scholarly journals The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jane Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Alexandra Czerniewska ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Infant Food ◽  
Food Hygiene ◽  
Randomized Controlled ◽  
Hygiene Intervention ◽  
Enteric Infections ◽  
Cluster Randomized ◽  
Start Trial ◽  
The Impact

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in low income urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targeted four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding, including when reheating or reserving; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The Safe Start trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children. Trial registration The trial was registered at clinicaltrial.gov on March 16th 2018 before enrolment of any participants (https://clinicaltrials.gov/ct2/show/NCT03468114).

scholarly journals The Safe Start Trial: A Cluster Randomized Controlled Trial for the Effect of an Infant Hygiene Intervention on Enteric Infections and Diarrhoea in Low-Income Informal Settlements of Kisumu, Kenya

2019 ◽  
Author(s):  
Jane Awiti Odhiambo Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Elizabeth Allen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Early Childhood ◽  
Controlled Trial ◽  
Infant Food ◽  
Food Hygiene ◽  
Randomized Controlled ◽  
Hygiene Intervention ◽  
Enteric Infections ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in poor urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of community health volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targeted four caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all food to the boil before feeding, including when reserving; 3) storing all food in sealed containers; and, 4) using specific utensils for feeding which are kept separate and clean. The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. Infant food samples were collected at 33 weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on food contamination. Discussion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, poor urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The study seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Seeing is believing: the impact of body-worn cameras on court outcomes, a cluster-randomized controlled trial in Miami Beach

2021 ◽  
Author(s):  
Kevin Petersen ◽  
Alejandro Mouro ◽  
Donald Papy ◽  
Noel Castillo ◽  
Barak Ariel
Keyword(s):  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Police Officers ◽  
Negative Binomial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Early Results ◽  
Cluster Randomized ◽  
The Impact

Abstract Objectives To assess the effects of BWCs on prosecutorial and court-related charge outcomes across multiple crime types, including domestic violence charges, crimes committed against police officers, and drug/alcohol charges. Methods A cluster-randomized controlled trial with 22 spatiotemporal police units assigned to BWCs and 17 assigned to control conditions. Data from the State Attorney’s Office were used to track convictions, adjudication withheld dispositions, and declined prosecutions for both experimental and control charges. A series of multilevel logistic and negative binomial regression models were used to estimate the effect of BWC footage on charge outcomes. Outcomes BWCs led to a significantly higher proportion of crimes against police officers resulting in convictions or adjudication withheld outcomes, and a significantly higher proportion of domestic violence charges resulting in convictions alone, compared to control charges. However, after the clustering effect was taken into account, only the effect of BWCs on crimes against police officers remained statistically significant. Conclusion These early results suggest that BWCs have significant evidentiary value that varies by crime type. BWCs may be best suited to capture evidence of crimes committed against police officers and potentially in domestic violence offenses as well.

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