Emollient Therapy for Severe Acute Malnutrition

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh

Conditions
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Child Malnutrition, Malnutrition in Children, Malnutrition

Intervention / Treatment
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* Other: Topical emollient (Sun Flower seed oil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent or legal guardian is willing and able to provide written informed consent for the subject to take part in the trial and comply with an inpatient stay of at least 10 days. Children aged 2-24 months inclusive diagnosed with SAM (weight-for-length Z score <-3 or bilateral pedal edema) admitted in the Dhaka Hospital of icddr,b, Dhaka, Bangladesh Willing to suspend usual home skin care treatments for the duration of study Exclusion Criteria: Consent refusal Life threatening health conditions such as septic shock and altered consciousness on admission; congenital problems (congenital heart disease or known metabolic disorders, chromosomal abnormalities, renal failure, etc.); any known chronic disease including tuberculosis, HIV infection History of drug or other allergy or any condition that may complicate the interpretation of safety or efficacy such as dermatitis which, in the opinion of the investigator, contraindicates participation in the trial, or know hypersensitivity to SSO The child is in care (no longer looked after by their parent or legal guardian) Participation in another study

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical Trial in two treatment arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emollient<br>Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition. | Other: Topical emollient (Sun Flower seed oil)<br>* 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.<br>|
| No Intervention: Control<br>Routine Standard of care only for severe acute malnutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of body weight | Body weight will be measured after 10 days of intervention | Baseline and 10th day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |