Emollient Therapy for Severe Acute Malnutrition

Trial ID or NCT#

NCT02616289

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 2 Months to 24 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Marc L. Melcher
Marc L. Melcher
Transplant surgeon, Liver transplant surgeon, Kidney transplant surgeon, Hepatobiliary surgeon, Dialysis access surgeon
Professor of Surgery (Abdominal Transplantation)
Frederick Mihm, M.D.
Frederick Mihm, M.D.
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (ICU)

View on ClinicalTrials.gov