TY - JOUR

T1 - Randomized, Controlled Trial Evaluating a Baby Wash Product on Skin Barrier Function in Healthy, Term Neonates

AU - Lavender, Tina

AU - Bedwell, Carol

AU - Roberts, Stephen

AU - Hart, Anna

AU - Turner, M.

AU - Carter, Lesley-Anne

AU - Cork, Michael

PY - 2013/3

Y1 - 2013/3

N2 - ObjectivesTo examine the hypothesis that the use of a wash product formulated for newborn (<1 month of age) bathing is not inferior (no worse) to bathing with water only.DesignAssessor-blinded, randomized, controlled, noninferiority trial.SettingA teaching hospital in the Northwest of England and in participants’ homes.ParticipantsThree-hundred-and-seven healthy, term infants recruited within 48 hours of birth.MethodWe compared bathing with a wash product (n = 159) to bathing with water alone (n = 148). The primary outcome was transepidermal water loss (TEWL) at 14 days postbirth; the predefined difference deemed to be unimportant was 1.2. Secondary outcomes comprised changes in stratum corneum hydration, skin surface pH, clinical observations of the skin, and maternal views.ResultsComplete TEWL data were obtained for 242 (78.8%) infants. Wash was noninferior to water alone in terms of TEWL (intention-to-treat analysis: 95% confidence interval [CI] for difference [wash–water, adjusted for family history of eczema, neonate state, and baseline] −1.24, 1.07; per protocol analysis: 95% CI −1.42, 1.09). No significant differences were found in secondary outcomes.ConclusionWe were unable to detect any differences between the newborn wash product and water. These findings provide reassurance to parents who choose to use the test newborn wash product or other technically equivalent cleansers and provide the evidence for health care professionals to support parental choice.

AB - ObjectivesTo examine the hypothesis that the use of a wash product formulated for newborn (<1 month of age) bathing is not inferior (no worse) to bathing with water only.DesignAssessor-blinded, randomized, controlled, noninferiority trial.SettingA teaching hospital in the Northwest of England and in participants’ homes.ParticipantsThree-hundred-and-seven healthy, term infants recruited within 48 hours of birth.MethodWe compared bathing with a wash product (n = 159) to bathing with water alone (n = 148). The primary outcome was transepidermal water loss (TEWL) at 14 days postbirth; the predefined difference deemed to be unimportant was 1.2. Secondary outcomes comprised changes in stratum corneum hydration, skin surface pH, clinical observations of the skin, and maternal views.ResultsComplete TEWL data were obtained for 242 (78.8%) infants. Wash was noninferior to water alone in terms of TEWL (intention-to-treat analysis: 95% confidence interval [CI] for difference [wash–water, adjusted for family history of eczema, neonate state, and baseline] −1.24, 1.07; per protocol analysis: 95% CI −1.42, 1.09). No significant differences were found in secondary outcomes.ConclusionWe were unable to detect any differences between the newborn wash product and water. These findings provide reassurance to parents who choose to use the test newborn wash product or other technically equivalent cleansers and provide the evidence for health care professionals to support parental choice.

KW - randomized

KW - term neonates

KW - wash product

KW - neonatal skin care

KW - transepidermal water loss

KW - noninferiority trial

U2 - 10.1111/1552-6909.12015

DO - 10.1111/1552-6909.12015

M3 - Journal article

VL - 42

SP - 203

EP - 214

JO - Journal of Obstetric, Gynecologic, and Neonatal Nursing

JF - Journal of Obstetric, Gynecologic, and Neonatal Nursing

SN - 1552-6909

IS - 2

ER -