Emollient Therapy for Severe Acute Malnutrition

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616289
• Other study ID #: PR-15101
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition
• Malnutrition in Children
• Severe Acute Malnutrition

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