Comparison of methods of oral rehydration therapy in children with acute diarrhea.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4b45px
• Date of registration: 10/04/2012
• Primary sponsor: Centro de Pesquisa Fima Lifshitz - Salavdor, BA, Brazil
• Public title: Comparison of methods of oral rehydration therapy in children with acute diarrhea.
• Scientific title: Comparison of methods of oral rehydration therapy in children with acute diarrhea.
• Date of first enrolment: 01/03/2011
• Target sample size: 70
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4b45px/
• Study design: Therapeutic, controlled, parallel, with 2 arms, single-blinded, randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Hugo Ribeiro Jr
• Affiliation: Centro de Pesquisa Fima Lifshtz/UFBA

• Name: Patricia Mendes
• Affiliation: Centro de Pesquisa Fima Lifshtz/UFBA

Key inclusion & exclusion criteria

Inclusion criteria: Male children 2-30 months old
Pre-classified with acute diarrhea and dehydration.
Exclusion criteria: Only breastfeeding nutrition
With severe malnutrition
With clinical suspicious or documented signs and symptoms of chronic illness or systemic infection
Not able to understand the nature of study and sign the inform consent

Age minimum: 2M
Age maximum: 30M
Gender: M

Health Condition(s) or Problem(s) studied

A00-B99

Children hospitalized with acute diarrhea and dehydration
C23.888.821.214.500

Intervention(s)

Group A (standard):Thirty-four children received during the maintenance phase of the standard Oral Rehydration Solution (ORS) with 90mmol/L sodium, 111mmol/L glucose and osmolarity of 311mmol/L, in equal volumes of the abnormal losses, in addition to free water and diet appropriate for their age.Until the cessation of diarrhea.
Group B (test): Thirty-six children in this group had made the replacement of abnormal losses with the same solution with a calculated volume that results from subtraction of the ingest the liquid diet (milk formula, breast milk, liquid soup and juice and water intake), using a formula for Balance Intake Minus Loss (BIML) in which BIML is equal to intake liquid in milliliter (ILmL) minus abnormal losses milliliter (ALmL). Formula: BIML=ILmL-ALml . Until the cessation of diarrhea

Primary Outcome(s)

Reduction of the duration of diarrhea (hours), as well as stool output (ml / kg / h) due to a lower water intake (ml / kg / day) without an increase in dehydration.
Water Balance held every 8hours:
All losses (faeces, vomit and urine output) collected in containers and clothing pre-weighed were measured on precision scales (OHAUS Triple Beam Balance Model, 2610 g capacity 5lb 2oz).
All oral intake was measured using the technique of rest-intake using a precision scale (DIGIPESO, model DP-3000, 3 kg capacity and accuracy 0.5 g).

Secondary Outcome(s)

No impairment in weight gain or caloric intake,
No increase in the number of vomiting, nor
disorder hydroelectrolytical.
The weight of each naked child was obtained in the same time (06, 14 and 22h) and before the meals using digital scale balance model BP Fillizola Baby™ with accuracy of 5grams.
For the measurement of caloric intake and vomiting, was performed the same procedure performed for the primary outcomes.
Electrolyte abnormalities (hypernatremia (Na> 150mmol / l), hyponatremia (Na <130 mmol / l) and hypokalemia (K <3 mmol / l)) were evaluated by laboratory tests.

Secondary ID(s)

121/2003

Source(s) of Monetary Support

Fundação de Apoio à Pesquisa do Estado da Bahia- FAPESB - Salvador, BA, Brazil

Secondary Sponsor(s)

Universidade Federal da Bahia - Salvador, BA, Brazil