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Completed

NCT Number: NCT02616289

Emollient Therapy for Severe Acute Malnutrition

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

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Key information

Age range

2 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhaka Hospital, icddr,b

Dhaka, 1212, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. changes of body weight

    Time frame: Baseline and 10th day

    Body weight will be measured after 10 days of intervention

Secondary outcomes

  1. Time to discharge from acute illnesses

    Time frame: 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.

  2. Reduction of rate of nosocomial infections between cases and controls

    Time frame: through study completion, an average of 10 days

    Reduction of rate of nosocomial infections between cases and controls

  3. Reduction in TEWL

    Time frame: baseline and 10th day

    Reduction in trans-epidermal water loss (TEWL) which will be measured by Tewameter

  4. Serum CRP level

    Time frame: 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.

  5. Serum Cytokines level

    Time frame: 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.

  6. Serum essential fatty acids (EFAs) level

    Time frame: 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.

  7. Skin condition changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • GlaxoSmithKline
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2015
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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