Emollient Therapy for Severe Acute Malnutrition
- Conditions
- Child MalnutritionMalnutrition in ChildrenMalnutrition
- Interventions
- Other: Topical emollient (Sun Flower seed oil)
- Registration Number
- NCT02616289
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emollient Topical emollient (Sun Flower seed oil) Topical emollient (Sun Flower seed oil) in addition to routine standard of care for severe acute malnutrition.
- Primary Outcome Measures
Name Time Method changes of body weight Baseline and 10th day Body weight will be measured after 10 days of intervention
- Secondary Outcome Measures
Name Time Method Skin condition changes Baseline and 10th day 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 to discharge from acute illnesses through study completion, an average of 5 days Time to discharge from acute illnesses like, diarrhea, pneumonia, enteric fever etc which usually associated with severe acute malnutrition.
Reduction in TEWL baseline and 10th day Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter
Serum CRP level Baseline and 10th day Serum CRP level will be assessed before and after the intervention to know the potential impact of the intervention on this change.
Serum Cytokines level Baseline and 10th day Serum Cytokines (inflammatory) level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Serum essential fatty acids (EFAs) level Baseline and 10th day Serum EFAs level will be assessed before and after the intervention to know the potential impact of the intervention on these changes.
Reduction of rate of nosocomial infections between cases and controls through study completion, an average of 10 days Reduction of rate of nosocomial infections between cases and controls
Trial Locations
- Locations (1)
Dhaka Hospital, icddr,b
🇧🇩Dhaka, Bangladesh