An interventional study of Topical emollient (Sun Flower seed oil) in Child Malnutrition, Malnutrition in Children and Malnutrition, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 2 Months to 24 Months. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Treatment
The investigators hypothesize that the absorption of topically applied EFA-containing emollient (SSO) into the skin and thence into the bloodstream in children with SAM will improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond that possible through normal standard-of-care
A child with SAM, in addition to wasting will often present with infection, hypothermia, dehydration and electrolyte imbalance - complications attributable, at least in part, to compromised skin barrier function. Essential fatty acid (EFA)-containing emollients such as sunflower seed oil (SSO) have been shown to augment skin barrier function, reduce transepidermal water loss (TEWL) and risk of bloodstream infection and mortality, and promote weight gain in preterm infants. Recent research from rural Bangladesh showed very low levels of EFAs in young children in the general population. It is believed that EFA levels will be further depleted in children with SAM. So the investigators aim to demonstrate the feasibility of topical applications of SSO to children with SAM, and to measure clinical impact of emollient therapy with SSO on skin barrier function, skin condition, EFA levels in blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute rehabilitation from SAM, in addition to the benefits of normal standard-of-care.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 212 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition.
Other: Topical emollient (Sun Flower seed oil)
Routine Standard of care only for severe acute malnutrition.
3 g of oil per kg of infant's weight at study entry of Sunflower Seed oil (SSO) will be applied three times per day at regularly spaced intervals (8-hour intervals) for 10 days. Oil will not be applied to the face (to avoid the possibility of any accidental aspiration or ingestion), ears or under the hairline. Care will be taken to not injure the skin during the massage treatment. The child's anal area will be washed prior to application to avoid the spread fecal flora from the anal region (to which the oil will be applied to last). Prior to bathing the child a minimum of 3-4 hours should have elapsed following the application of the SSO. The amount of oil required will be calculated based on the child's weight and the required amount weighed out each time.
changes of body weight
Body weight will be measured after 10 days of intervention
Time frame: Baseline and 10th day
Time to discharge from acute illnesses
Time to discharge from acute illnesses like, diarrhea, pneumonia, enteric fever etc which usually associated with severe acute malnutrition.
Time frame: through study completion, an average of 5 days
Reduction of rate of nosocomial infections between cases and controls
Reduction of rate of nosocomial infections between cases and controls
Time frame: through study completion, an average of 10 days
Reduction in TEWL
Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter
Time frame: baseline and 10th day
Serum CRP level
Serum CRP level will be assessed before and after the intervention to know the potential impact of the intervention on this change.
Time frame: Baseline and 10th day
Serum Cytokines level
Serum Cytokines (inflammatory) level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Time frame: Baseline and 10th day
Serum essential fatty acids (EFAs) level
Serum EFAs level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Time frame: Baseline and 10th day
Skin condition changes
Clinical improvement of skin conditions will be measured by a predefined skin scoring system where the value of the score increase proportionately (score '0' in normal skin condition) with the skin changes. Investigators will compare the score with baseline after intervention among the groups.
Time frame: Baseline and 10th day
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh