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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Stanford University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emollient | Experimental | Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition. |
|
| Control | No Intervention | Routine Standard of care only for severe acute malnutrition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical emollient (Sun Flower seed oil) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes of body weight | Body weight will be measured after 10 days of intervention | Baseline and 10th day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 5 days |
| Reduction of rate of nosocomial infections between cases and controls |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K M Shahunja, MBBS | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Hospital, icddr,b | Dhaka | 1212 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34386216 | Derived | Fischer N, Darmstadt GL, Shahunja KM, Crowther JM, Kendall L, Gibson RA, Ahmed T, Relman DA. Topical emollient therapy with sunflower seed oil alters the skin microbiota of young children with severe acute malnutrition in Bangladesh: A randomised, controlled study. J Glob Health. 2021 Jul 17;11:04047. doi: 10.7189/jogh.11.04047. eCollection 2021. | |
| 34092255 |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004643 | Emollients |
| ID | Term |
|---|---|
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Clinical Trial in two treatment arms
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|
Reduction of rate of nosocomial infections between cases and controls |
| through study completion, an average of 10 days |
| Reduction in TEWL | Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter | 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. | 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. | 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. | 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. | Baseline and 10th day |
| Shahunja KM, Sevin DC, Kendall L, Ahmed T, Hossain MI, Mahfuz M, Zhu X, Singh K, Singh S, Crowther JM, Gibson RA, Darmstadt GL. Effect of topical applications of sunflower seed oil on systemic fatty acid levels in under-two children under rehabilitation for severe acute malnutrition in Bangladesh: a randomized controlled trial. Nutr J. 2021 Jun 6;20(1):51. doi: 10.1186/s12937-021-00707-3. |
| 32509290 | Derived | Shahunja KM, Ahmed T, Hossain MI, Mahfuz M, Kendall L, Zhu X, Singh K, Crowther JM, Singh S, Gibson RA, Darmstadt GL. Topical emollient therapy in the management of severe acute malnutrition in children under two: A randomized controlled clinical trial in Bangladesh. J Glob Health. 2020 Jun;10(1):010414. doi: 10.7189/jogh.10.010414. |