DeHydration: Assessing Kids Accurately

NCT02007733 | Completed DMC

• 2 other identifiers: 4701251K01TW009208-01A1
• Study Type: observational
• Target: 1,396
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Dehydration

Keywords

Diarrhea; Dehydration; Children; Resuscitation; Clinical Prediction Rule; Low Income Country; Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Area under the receiver operating curve for predictors of some dehydration

  2 weeks

Other Outcomes (1)

• Sub-group analyses

  2 weeks

Study Arms (2)

Derivation Cohort

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.

Other: Serial Weights; Other: IVC/Aorta Ultrasound; Other: Clinical Assessment

Validation Cohort

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.

Other: Serial Weights; Other: Clinical Assessment

Interventions

Serial Weights OTHER

We will collect serial weights on all children enrolled in this study.

Derivation Cohort; Validation Cohort

IVC/Aorta Ultrasound OTHER

We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.

Derivation Cohort

Clinical Assessment OTHER

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.

Derivation Cohort; Validation Cohort

Eligibility Criteria

• Age: 1 Month - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children under five with acute diarrhea observed in the rehydration ward of the Dhaka Hospital of ICDDR,B.

You may qualify if:

• Age 5 years (60 months) or younger
• History of diarrhoea (defined as 3 or more loose stools per day)
• Children observed in the rehydration ward

You may not qualify if:

• Chronic diarrhoea (greater than 2 week duration)
• Clear alternative diagnosis to gastroenteritis on presentation
• Previously enroled in this research study

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Fogarty International Center of the National Institute of Health: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Dhaka Hospital of ICDDR,B

Dhaka, Bangladesh

Location

Related Publications (3)

• 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.

  PMID: 26374802 RESULT

• 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.

  PMID: 27567350 RESULT

• 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.

  PMID: 25972523 DERIVED

Related Links

• Principal Investigator Website

MeSH Terms

Conditions

Dehydration; Diarrhea

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Adam C. Levine, MD, MPH

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 11, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 23, 2023

Record last verified: 2015-10

Locations

BA (1)