Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children

A Small, Randomized, Split Body, Controlled, Blinded Pilot Study

Teresa Løvold Berents; Jørgen Rønnevig; Elisabeth Søyland; Peter Gaustad; Gro Nylander; Beate Fossum Løland

Disclosures

BMC Dermatol. 2015;15(7) 

In This Article

Methods

Trial Design

This was a split body controlled, randomized and physician blinded study of expressed human milk and emollients on contralateral eczema spots in children, the trial was registered at ClinicalTrials.gov Identifier, NCT02381028.

Inclusion criteria were children with AE according to Hanifin and Rajkas criteria[11] with a mother breastfeeding the child or a sibling. The eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body. Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.

The study was approved by the Regional Committee for Medical and Health Research Ethics - South East Norway. Mothers of participating children were informed verbally and in writing, and signed an informed consent prior to commencing the study.

Recruitment

Study patients were recruited through advertisement posters from three different well baby clinics in Oslo, Norway, in the period 2008–2011. Mothers interested in the study contacted the study team. The consultations mainly took place at the hospital; a few were carried out in the child's home. The mothers were able to contact the examining physician if they experienced any problems with the treatment.

Intervention

The study intervention was local application of fresh human milk on the study area. By hand milking, the mothers were to squeeze out and throw away the first few droplets of milk, and then squeeze the next droplets directly from the nipple to the eczema spot. The number of milk droplets depended on the size of the eczema area; the mothers were instructed to cover the whole eczema spot with milk. After absorption of the milk droplets, both treatment and control areas were treated with moisturizing cream (Apobase creme®, Actavis Norway AS). The cream contains: Aqua, Paraffinum Liquidum, Petrolatum, Cetearyl Alcohol, Ceteareth-20, Ceteareth-12, Sodium Gluconate, Caprylyl Glycol, Phenoxyethanol, with a total lipid content of 30 percent. Both intervention and control areas were treated with this regimen three times a day for four weeks.

Randomization and Blinding

The same physician examined all the children, and was blinded as to which areas were the control or intervention sites. At inclusion the physician diagnosed the AE according to Hanifin and Rajkas criteria.[11] The two contra-lateral eczema spots to be randomized were elected; i.e. flexural aspect of elbow, flexural aspect of knees or cheeks. Another physician, who did not see the child, was responsible for the randomization. The child was given a randomization number and the mothers were then informed on which side to apply the fresh expressed human milk and emollient, and on which side to apply emollient alone.

Follow-up

After inclusion, the children were examined once weekly for four consecutive weeks. The overall severity of AE was evaluated by the use of SCORAD, which defines mild disease as score <25, moderate disease between 25–50 and severe disease as scores >50.[12] The severity of the study and control areas were evaluated by scoring the erythema, lichenification, excoriation and pruritus on a scale from 0 to 3, where 0 is none and 3 is severe. Study and control areas were measured using Visitrak™ (Smith & Nephew), a portable device used to measure the area of wounds.[13] A transparent folio is placed over the area and the borders are outlined, whereafter a computer determines the area measured in cm2. In the present study this device was used to follow the development of the extent of the eczema spots.

At each visit, samples for bacterial cultures were taken at eczema spots and from breastmilk, using Amies Agar Gel with CharcoalTM, Copan Venturi Transystem® (Copan, Brescia, Italy). Sampling from eczema spots was done by carefully rubbing the cotton swab over the eczema spot. Sampling of breastmilk was done from milk expressed by hand milking. The specimens were cultivated on blood agar plates and selective media for S. aureus and for gram-negative rods.

Outcome

The primary outcome was to register proportional change in the area of the eczema spot from baseline, as measured by Visitrak™. The secondary outcome was to assess transmission of bacteria from mother's milk to eczema spots in the child. The mother's compliance was also evaluated.

Statistical Methods

Descriptive statistics were performed. The areas of the intervention and control sites for each child were not identical; therefore differences were calculated as percentages: Changes in the areas of the control and intervention sites each week were calculated as change in proportion of area related to baseline area.

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