NCT02007733|CompletedDMC
DeHydration: Assessing Kids Accurately
DHAKA
Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh
Loading search results
DHAKA
Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh
Sponsor study identifier
Secondary identifiers
observational
1,396
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Diarrhea is the second leading cause of death in children worldwide, and accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality from this disease. While children with severe dehydration require immediate treatment with intravenous fluids, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). While several clinical scales have been developed for assessing dehydration in children, these scales have never been prospectively validated in a low-income country setting, where the vast majority of diarrhea morbidity and mortality occurs in children. The investigators hypothesize that new clinical and ultrasound-based tools will improve the diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration as well as the adverse events and inappropriate utilization of scarce resources that occurs as a result of over-diagnosis of severe dehydration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2013
Actual (reported)December 11, 2013
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 2015
Actual (reported)June 2015
Actual (reported)Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease
We will follow all enrolled children for up to a maximum of 2 weeks to assess the percent change between initial dehydrated weight and stable rehydration weight or post-illness weight. Greater than 9% weight change or death prior to achieving stable weight will be our criterion standard for severe disease. We will then determine the area under the Receiver-Operator Characteristic (ROC) curves for our newly derived clinical scale (DHAKA scale); for ultrasound of the IVC to Aorta ratio; and for the WHO scale as predictors of severe diarrheal disease in children enrolled in our study.
2 weeks
Area under the receiver operating curve for predictors of some dehydration
2 weeks
Sub-group analyses
2 weeks
The derivation cohort includes patients enrolled in the first phase of the study, from February 2014 to June 2014. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta.
The validation cohort includes patients enrolled in the second phase of the study, from March 2015 to May 2015. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta.
We will collect serial weights on all children enrolled in this study.
We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.
Children under five with acute diarrhea observed in the rehydration ward of the Dhaka Hospital of ICDDR,B.
Dhaka Hospital of ICDDR,B
Dhaka, Bangladesh
Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Rege S, Chu C, Schmid CH, Alam NH. Empirically Derived Dehydration Scoring and Decision Tree Models for Children With Diarrhea: Assessment and Internal Validation in a Prospective Cohort Study in Dhaka, Bangladesh. Glob Health Sci Pract. 2015 Aug 18;3(3):405-18. doi: 10.9745/GHSP-D-15-00097.
Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Atika B, Rege S, Robertson S, Schmid CH, Alam NH. External validation of the DHAKA score and comparison with the current IMCI algorithm for the assessment of dehydration in children with diarrhoea: a prospective cohort study. Lancet Glob Health. 2016 Oct;4(10):e744-51. doi: 10.1016/S2214-109X(16)30150-4. Epub 2016 Aug 23.
Adam C. Levine, MD, MPH
Brown University
1,396 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2013
First Posted
December 11, 2013
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Neuromuscular Blockade's Monitoring and Clinical Assessment During Cisatracurium Paralysis in Critically Ill Patients
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's Disease
We will perform a clinical assessment of dehydration status in each child enrolled in the study, as well as collect data on mid-upper arm circumference, length, symptoms and demographic information.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Modi P, Nasrin S, Hawes M, Glavis-Bloom J, Alam NH, Hossain MI, Levine AC. Midupper Arm Circumference Outperforms Weight-Based Measures of Nutritional Status in Children with Diarrhea. J Nutr. 2015 Jul;145(7):1582-7. doi: 10.3945/jn.114.209718. Epub 2015 May 13.
Primary Completion
May 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
February 23, 2023
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: