Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201511001180444 Date of Approval: 23/06/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A STUDY TO COMPARE EFFECTIVENESS OF CAREGIVER FLUID CHARTS VERSUS STANDARD OF CARE IN THE MANAGEMENT OF SOME DEHYDRATION SECONDARY TO DIARRHOEA
Official scientific title CAREGIVER ORS FLUID CHARTS VERSUS STANDARD CARE FOR THE MANAGEMENT OF SOME DEHYDRATION SECONDARY TO ACUTE DIARRHOEA AMONG KENYAN CHILDREN: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Acute diarrhoea continues to be a leading cause of morbidity and mortality worldwide. This is especially so in low income countries where burden is high and healthcare personnel are few. Mortality rates are still high despite major advances in prevention and treatment, involving the use of oral rehydration solutions. Studies have shown that monitoring of care is associated with reduction in mortality and admissions. This highlights the need to focus on proper use, monitoring and reassessment during administration of oral rehydration solutions. The primary objective was to compare hydration status and frequency of admissions following four hours of treatment in patients with some dehydration secondary to acute diarrhoea randomized to the use of the oral rehydration solution fluid charts recorded by guardians with those not using the charts. The secondary objective was to assess the acceptability of the charts.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diarrhoea,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2014
Actual trial start date 22/07/2014
Anticipated date of last follow up 19/12/2014
Actual Last follow-up date 15/01/2015
Anticipated target sample size (number of participants) 268
Actual target sample size (number of participants) 268
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Caregiver ORS fluid chart 4 hours The caregiver ORS fluid chart was formulated using the concept of feeding charts and modified to asses and monitor ORS administration in the outpatient setting. It recorded the volume of fluid required, the actual amount given to the child as well as the frequency of vomiting and diarrhea on an hourly basis. Also received instructions on ORS administration as control group 134
Control Group Standard of care group 4 hours This constituted administration of ORS at a volume of 75ml/kg over a 4-hour period given as frequent sips from a cup (age 2 years and above) or by cup and spoon (age below 2 year) 134 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Children aged 2-59 months with WHO defined acute diarrhoea and WHO-defined some dehydration. 2. Written informed consent for study participation obtained from parent or guardian. 3. Caregiver with ability to read and write. 1. Children with severe malnutrition defined as WHZ score < -3SD below WHO reference mean. 2. Children with severe dehydration defined as inability to drink or AVPU < A plus sunken eyes and return of skin pinch > 2s. 3. Children with shock defined as all four of weak pulse, cold hands and temperature gradient, capillary refill > 3s, AVPU< A, plus sunken eyes and slow skin pinch. 4. Children with dysentery defined as presence of blood in stool. 5. Children with comorbid conditions requiring admission for inpatient management. 2 Month(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/05/2014 Kenyatta National Hospital/ University of Nairobi - Ethics Research Committee.
Ethics Committee Address
Street address City Postal code Country
hospital road,uppe rhill Nairobi P.O BOX 20723-00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome variables were the frequency of hospitalization and hydration status after four hours of treatment. Assessed at four hours following administration of ORS.
Secondary Outcome The secondary outcome was the acceptability of ORS fluid charts broadly categorized into positive or negative caregiver responses. At four hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbagathi District HOspital Dagorreti Nairobi P.O BOX 40205 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
prime K hospital road,upper hill Nairobi p.o box 30197-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor prime K hospital road,upper hill Nairobi p.o box 30197-00100 Kenya Funding Agency
Primary Sponsor Mukokinya Kailemia ngong road, kilimani Nairobi p.o box 29787-00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Mbagathi way, ngong road Nairobi P.O BOX 30016-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mukokinya Kailemia mukokinya@gmail.com 254736120932 Ngong road
City Postal code Country Position/Affiliation
Nairobi P.O BOX 29787-00202 Kenya Department of Pediatrics and Child health, University of Nairobi, Nairobi, Kenya
Role Name Email Phone Street address
Public Enquiries Karumba Ken kkarumba@uonbi.ac.ke 254721659676 hospital road, upper hill
City Postal code Country Position/Affiliation
Nairobi P.O BOX 19676-00202 Kenya Administrator PRIME-K
Role Name Email Phone Street address
Scientific Enquiries Wamalwa Dalton dalton@africaonline.co.ke 254721239493 hospital road, upper hill
City Postal code Country Position/Affiliation
Nairobi P.O BOX 19676-00202 Kenya Associate professor, Department of pAediatrics
REPORTING
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