Amer 2017.

Study characteristics
Methods	Study design: randomised controlled trial Study conducted: April 2014 and September 2014 Treatment arms: 2 AD follow‐up: 4 weeks
Participants	Randomised: N = 70 (group A underwent care n = 35, group B did not undergo care n = 35)  Inclusion criteria:  Healthy and full‐term (determined by mothers’ obstetrician/gynaecologist) 1 to 7 days old at baseline Mothers of infant participants had to be older than 18 years and were told to refrain from using their infants’ current lotion products (if applicable) for the duration of the study Mothers agreed not to introduce fragrances on themselves, on their infant, or in their household for the duration of the study Mothers also agreed to avoid excessive sun exposure on their infants’ arms and legs Exclusion criteria:  Infants suffering from any known abnormal skin conditions (rash), hypersensitivity, or allergic reactivity to fragrances or other ingredients Infants suffering from asthma, upper respiratory tract infection, or other conditions that would affect the evaluation of skin care regimens Infants with any genetic abnormalities Premature infants
Interventions	Intervention:  Caregivers/mothers were instructed to provide a specific skin care regimen  Caregivers (if possible) were instructed to gently dry the baby immediately after birth and to gently remove any blood or meconium and to not rub off the vernix (leave it as intact as possible to absorb into the skin) During the 4 weeks of the study, neonates were bathed at variable frequencies by mothers most often 1 to 2 times per week using shampoo as a cleanser; sometimes baby wipes were used as an alternative to bathing. The first bath was given only when the temperature of the newborn was stabilised, instead of considering only the number of hours after birth, and usually during the first week. Mothers were instructed to apply oil to the skin and the scalp 3 to 4 times per week and after bath time, and that this should be applied daily when signs of dryness (flaking/scaling) were presented. Mothers were instructed to keep the umbilical cord clean and dry by applying chlorhexidine in the first 10 days of life until the cord falls off and 2 days after, and allowing it to be exposed to air as frequently as possible. Mothers were instructed to use the best quality nappy available, to change soiled nappies frequently, to cleanse the nappy area with plain water or unperfumed, alcohol‐free baby wipes, to expose the nappy area as often as possible, and to consider using a thin layer of barrier ointment or cream with nappy changes. Mothers were instructed to care for the neonatal intertrigo by keeping it clean and dry. A colourful and informative booklet had been designed for the mothers, which clarifies instructions about care of neonatal skin and benign transient neonatal skin disorders for the reassurance of parents Comparator: group B: did not undergo care; no specific intervention   Shampoo, baby oil, wipes, and cream ingredients:  Baby shampoo, which is composed of sodium lauroamphoacetate, sodium laureth sulfate, coco glucoside, polyquaternium‐10, and sodium benzoate. Baby oil is a mineral oil that contains paraffinum liquidum, isopropyl palmitate, and parfum, which are safe. It is used as a moisturiser and for massage. Baby wipes consist of a non‐woven carrier soaked with an emulsion‐type watery or oily lotion. Baby cream consists of zinc oxide and olive oil
Outcomes	Primary outcomes: optimal skin function, mothers' visual skin assessment questionnaire to evaluate the presence of neonatal skin for erythema and dryness. Clinical examination for skin assessment for appearance of erythema, dryness, and infection or any skin disorders or adverse effects on a weekly basis Adverse events: adverse events were recorded when the baby's skin was assessed during weekly clinical examination The only adverse effect of this study was a case of milaria using emollient because the mother turned on the heater all night, which turns the atmosphere hot and humid; this conclusion is in agreement with a study by Rocha et al., which found that emollient may cause acne, folliculitis, and prickly heat, and may aggravate pruritus when used in extremely hot and humid areas
Identification	Country: Egypt Setting: outpatient clinics at the Dermatology and Venereology Department, Obstetric Department, and Pediatric Department, Faculty of Medicine, Zagazig University Hospitals Sponsorship source: not reported
Declarations of interest	Not reported
Notes