Modified ORS Solution for Severely Malnourished Children
|ClinicalTrials.gov Identifier: NCT01821586|
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malnourished Children With Watery Diarrhoea||Other: Modified ORS-1 Other: Modified ORS-2 (ReSoMal) Other: Modified ORS-3 (Benefibre)||Phase 2|
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Study Design This will be a randomized, double-blind, controlled clinical trial to assess the efficacy of three different modified ORSs: (i) Currently recommended ORS with some modification (Na+ 75, K 40 mmol/L and added minerals); (ii) Resomal (Na+ 45); (iii) Currently recommended ORS (Na+ 75 , K 40 mmol/L and added minerals) with added benefiber (25 grams/L) in the treatment of acute watery diarrhoea in children with severe malnutrition.
STUDY POPULATION Children of either sex, aged 6 months to 3 years, presenting with acute watery diarrhoea of <7 days duration will be screened.
The sample size of this study has been determined based on the followings:
- Persistence of hyponatraemia: We anticipate that 10% of the children will remain hyponatraemic in the Modified ORS-1 treatment group compared to 30% children in the Modified ORS-2 (ReSoMal). Assuming 5% level of significance and 80% power, the sample size in each group is 60.
- Recovery from diarrhoea: In a recent clinical trial33 of ORS solution in severely malnourished children with acute watery diarrhoea, the mean +SD duration of diarrhoea was 66 (32) h. We anticipate that a 25% reduction in the diarrhoea duration in children receiving Benefiber-added ORS. Considering 5% level of significance and 80% power the required sample size in each group is 59.
Anticipating a drop out of around 5% we need 62 children in each group. Randomization
After enrolment into the study the patient will be randomized to receive one of the following three solutions:
Following the standardized protocol for management of severely malnourished children used at ICDDR,B hospital 20,23.
5.1 Fluid therapy (oral) Dehydration will be assessed according to the WHO guidelines, modified for in our last multicentre clinical trial of reduced osmolarity ORS in adult cholera and children with watery diarrhoea (17). In children with some dehydration, the fluid deficit will be corrected with the assigned ORS @ 10ml/kg/hr for the first two hours, then 5ml /kg/hr until the deficit will be corrected. In addition, on going stool looses will be replaced @ 5-10 ml/kg/hr after each watery stool. For high purging patient, the ORS intake will be adjusted according to the ongoing stool loss. ORS therapy will be continued until diarrhoea ceased. Children with severe dehydration, initial rehydration will be done with IV fluid(cholera saline) until the patient is out of shock or disappearance of signs of severe dehydration then the rest of the rehydration will be done as for rehydration in patients with some dehydration as described above.
5.2 Management of infection: Children without apparent extraintestinal infection will receive Inj ampicillin 100 mg/kg.24 h in 3 divided doses and Inj. Gentamicin @ 5ml/kg.24 h in 2 divided doses for 5 days. Children with lower respiratory tract infection will receive Inj. Ceftriaxone 75 mg /kg.day for 5 days, and those with cholera will receive syrup Azithromycin 20 mg/kg once within 20 minutes of randomization.
5.3 Diet: Mothers will be advised to continue breastfeeding. Supplementary feeding with milk suji (milk, rice powder mixture, energy 70 kcal/100ml) will be given 10 ml/Kg.feed two hourly for day 1 and increased slowly up to 150 Kcal/Kg.day over 7 days according to demand. If the child has poor appetite, or is weak, or has painful stomatitis or glossitis, food will be delivered through nasogastric tube until able to take food orally. Additionally, semisolid foods (Rice, lentil, vegetable etc.) will be given to older children during convalescent and rehabilitation phase.
5.4 Vitamin and Mineral Supplements Children older than one year without xeropthalmia will be given 200,000 units of vitamin A and those 6-12 months age will be given 100,000 units of vitamin A on admission. Children with xeropthalmia will receive the same dose on three occasions: on admission, on the following day, and at discharge. Folic acid 1.25 mg and elemental zinc 2 mg/kg will be given until discharge and some medicine will be supplied with the patient to continue upto 15 days. Children will also receive multivitamin drops (1 ml contains Vit A palmitate 5000 IU, vitamin D 1000 IU, thiamine hydrochloride 1.6 mg, riboflavin 1 mg, pyridoxine hydrochloride 1 mg, nicotinamide 10 mg, calcium D- pantothenate 5 mg, and ascorbic acid 50 mg) in a dose of 1 ml twice daily until discharge and some medicine will be supplied with the patient to continue upto 15 days (half the dose for infants, aged <1 year). Hypoglycemia (blood glucose <3.0 mmol/L) will be managed with 50 ml 10% glucose orally or by nasogastric tube. Inj 25% glucose 2 ml/kg will be given if the level of blood glucose below 1.5 mmol/L. Hyponatraemia (serum sodium <115 mmol/L with or without symptoms) will be managed with Inj. 3% NaCl 12 ml/kg I/V slowly over 4 hours.
- Measurements 6.1 Fluids intakes ( IV, ORS and water) every 6 hours IV fluid will be infused through a calibrated soluset, the amount infused will be noted every 6 hours if the patient is receiving; ORS will be supplied after measuring with a calibrated cylinder and the amount of intake will be noted every 6 hours, if any left over that will be deducted from previous offer. Water will also be measured in a similar way.
6.2 Output (stool, urine and vomit) every 6 hours. Stool will be collected in a bucket of known weight beneath the cholera cot with a central hole and measured every 6 hours with an electronic scale of a precision of 1g. Urine will be collected by pediatric urine collector bag and measured with a calibrated cylinder in ml. Vomit will be collected in a pre-weighed bowl and measured with an electronic scale 6.3 Food intake every 6 hours The children will be offered a defined food of known calorie after measuring with an electronic scale of precision of 1g. Any left over will be measured and subtracted from the amount offered and amount ingested will be recorded every 6 hours. The calorie intake will be estimated from the amount of diet the child consumed.
6.4 Nude body weight will be measured at admission, after rehydration and every 6 hours until recovery of diarrhoea and then at the end of every 24 hours and at discharge
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Optimisation of Oral Rehydration Solution and Evaluation of the Efficacy of Benefiber(Partially Hydrolyzed Guar Gum) Containing Modified Oral Rehydration Solution in the Treatment of Severely Malnourished Children With Watery Diarrhoea|
|Study Start Date :||April 2006|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
Experimental: Modified ORS-1
Modified ORS -1 will be assigned to the enrolled particfipants according to the randomization schedule.
|Other: Modified ORS-1|
Experimental: Modified ORS-2 (ReSoMal)
Modified ORS -2 (ReSoMal) will be assigned to the enrolled particfipants according to the randomization schedule.
|Other: Modified ORS-2 (ReSoMal)|
Experimental: Modified ORS-3 (Benefibre)
Modified ORS -3 (Benefibre) will be assigned to the enrolled particfipants according to the randomization schedule.
|Other: Modified ORS-3 (Benefibre)|
- Stool weight [ Time Frame: up to 72 hours ]Collection of stool in cholera cot and measured every 6 hours with a using a electronic scale
- Duration of Diarrhoea [ Time Frame: up to 72 hours ]Time from the onset of randomization upto the stopage of diarrhoea
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821586
|Dhaka Hospital, icddr,b|
|Dhaka, Bangladesh, 1212|