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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616289
Other study ID # PR-15101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date December 31, 2019

Study information

Verified date December 2019
Source International Centre for Diarrhoeal Disease Research, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Completed
Enrollment 212
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 24 Months
Eligibility 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

Study Design


Intervention

Other:
Topical emollient (Sun Flower seed oil)
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.

Locations

Country Name City State
Bangladesh Dhaka Hospital, icddr,b Dhaka

Sponsors (3)

Lead Sponsor Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh GlaxoSmithKline, Stanford University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes of body weight Body weight will be measured after 10 days of intervention Baseline and 10th day
Secondary 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
Secondary 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
Secondary Reduction in TEWL Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter baseline and 10th day
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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