D

R STAN
E N
UND WBOR
NE KIN
S

An evidence-based approach to
newborn skin cleansing
Written by Sue Lyon, Medical Writer & Editor
For more information please contact:
JOHNSON’S® Baby Professional Support by email at jbhcpcontact@its.jnj.com

A professional educational supplement developed and produced by Johnson & Johnson Ltd, the makers of
JOHNSON’S® Baby. The Royal College of Midwives does not endorse any particular products from any manufacturer.
2

Introduction
Contents
Skin cleansing is essential for good health, but is especially relevant to infants,
whose skin needs special care because of its developing structure, function and
composition (Stamatas et al, 2011). Establishing good practice from birth is a
02 foundation for healthy skin throughout life, but approaches to infant skin care
Current evidence are often based on tradition, personal experience and cultural factors (Ness
and opinion et al, 2013). Family and friends can influence approaches to infant skin care,
but parents are also likely to turn to health professionals such as midwives as
04 trusted sources of information and advice (Lavender et al, 2009).
Understanding
newborn skin Current UK clinical guidelines recommend bathing newborns in water alone,
05 using a mild, non-perfumed soap where required (NICE 2006). However, water
The importance has been shown to irritate and dry the skin (Tsai and Maibach 1999), and some
of effective skin health professionals and women are sceptical about its effectiveness as a
cleansing cleanser when it is used alone (Lavender et al, 2009). Soap cleanses the skin,
but it has been shown to impair the integrity of the skin barrier and its use
07 has been cited as one of the most important factors in rising rates of atopic
New evidence on dermatitis in infants (Cork et al, 2009).
infant cleansing
The current inconsistencies between evidence and national guidelines on
08 newborn skin care have resulted in inconsistencies in professional practice and
Conclusions advice to mothers (Lavender et al, 2009; Walker et al, 2005). The result has
been confusion among parents, who may choose skin care products for their
08
baby on the basis of trial and error rather than evidence (Lavender et al, 2009).
References
It is important for health professionals such as midwives to be aware of both
the evidence base on newborn cleansing and the need to provide women with
an honest and clear picture where possible, allowing them to make their own
decisions about their choices (Bedwell and Lavender, 2012). This supplement
examines the latest research on the skin barrier in infants, and discusses
recently published evidence and clinical studies researching best practice in
infant skincare. The latest data provides evidence that the specially formulated,
mild and gentle, pH-neutral cleansers investigated in these studies are safe and
effective when used to cleanse newborn skin (Lavender et al 2012, Lavender et
al, 2013).

Current evidence and opinion

The National Institute of Health and Care
Excellence (NICE) is a key national organisation
for any healthcare professional, including
midwives, looking for evidence-based guidance.
NICE published guidelines on the routine
postnatal care of women and their babies in
July 2006 (NICE 2006). In the brief section on
routine skin care, NICE recommends against
adding cleansing agents to a baby’s bath water
or using lotions or medicated wipes, and the
only cleansing agent suggested was a mild,
non-perfumed soap. However, these current
NICE guidelines on routine newborn skincare
are based on expert opinion, rather than clinical
evidence.
When formulating guidelines, NICE aims to
determine the most effective and cost-effective
care, based on a careful review of the best
available evidence (NICE 2006). NICE reviews
the quality of each clinical trial or other type
of evidence and then assigns a value or level.
In this hierarchy, high-quality randomised
controlled trials provide the best or level-1
evidence, followed by systematic reviews, case-
control or cohort studies (level 2), case reports
or case series (level 3), and expert opinion or
formal consensus (level 4) (NICE 2006).
NICE reviewed the evidence base for the
routine postnatal care guidelines between 2004
and 2006 (NICE 2006). At that time, NICE
was unable to find any research studies on the
general care of newborn skin (Dermott et al,
2006). Consequently, this latest NICE guidance
on routine infant skin care was a good practice

point (level-4 evidence) based on the
opinion of the experts in the guideline
development group rather than on level-1
evidence from randomised controlled
trials (Dermott et al, 2006).
Since 2012, new evidence on newborn
skin care has become available following
the publication of two large randomised
controlled trials (Lavender et al, 2012;
Lavender et al 2013). These findings
may be used to inform evidence-based
practice.
CONTINUING DEBATE
In addition, other experts have
come to further conclusions about
optimum infant skin care. In 2009, a
European Round Table panel of expert
dermatologists and paediatricians
published evidence-based, consensus
advice on routine infant cleansing
during the first year of life. After a
comprehensive review of the evidence,
the group recommended using mild,
thoroughly tested liquid cleansers rather
than water alone for newborn cleansing.
They advised against using water alone
or soap and water, citing evidence that
these approaches are associated with
adverse effects on infants’ skin, including
dryness, irritation and atopic dermatitis
(Blume-Peytavi et al, 2009).
The US Association of Women’s
Health, Obstetric and Neonatal Nurses
(AWHONN) has also reviewed evolving
evidence on neonatal skin care. In
the third, 2013 edition of its clinical
practice guideline, AWHONN provides
evidence-based recommendations on
protecting the newborn’s delicate skin
and promoting an intact and healthy
skin barrier (AWHONN 2013). This
comprehensive, practical guideline
includes detailed advice on routine
bathing procedures and choice of
WHY ARE RANDOMISED
CONTROLLED TRIALS IMPORTANT?
Randomised controlled trials are
regarded as the gold-standard
method of evaluating the effectiveness
of a treatment or other intervention.
These trials have several important
features:
•R
 andom allocation of trial
participants to intervention and
control groups to eliminate any
bias and ensure that the treatment
group is as similar as possible to the
control group
•P
 articipants and investigators
should remain unaware of which
treatment was given (‘blinded’) until
the study is completed, although
such double-blind studies are not
always feasible
or appropriate
•A
 ll intervention groups are treated
identically except for
the experimental treatment
•P
 articipants are normally analysed
within the group to which they were
allocated irrespective of whether
they experienced the intended
intervention (called intention-
to-treat analysis)
•T
 he analysis of the trial results
focuses on estimating the size of
any difference between intervention
groups according
to predefined outcomes
Based on: Akobeng 2005
cleanser, recommending use of skin
cleansers that have minimal impact on
a baby’s skin surface pH. The guideline
also includes practical advice that
midwives may find helpful when parents
seek advice on choosing a cleanser for
their baby’s skin.
3
Other authors have considered the
evidence and joined the debate on
newborn cleansing. A review of studies
published between 2000 and 2010
reported no harmful effects on skin
from either water or wash products
during the first year of life (Crozier
and Macdonald 2010). More recently, a
similar analysis found that daily bathing
with specially formulated products has
no negative effects on normal skin or
skin showing erythema, indurations or
dryness (Blume-Peytavi et al, 2012). A
second group of authors subsequently
concluded that the safest cleansing
products for full-term newborns are mild,
neutral-pH cleansers without added dyes
or fragrances (Ness et al, 2013).
Given the current lack of expert
consensus and evidence-based national
guidance for healthcare professionals, it
is not surprising that there is ‘informed
uncertainty’ among midwives, who
draw on tradition, experience and
opinion to inform their clinical practice
(Lavender et al, 2009). The result is
confusion among mothers, who may not
reveal that they disregard professional
advice and use baby skin care products
(Lavender, et al 2009). This may be
especially the case for women who lack
confidence in the effectiveness of water
alone when faced with the practical
realities of dealing with a soiled nappy
(Furber et al, 2012).
CHOOSING CLEANSERS FOR
NEWBORN SKIN (AWHONN 2013)
•T
 he role of cleansers is to emulsify
oil, dirt and micro-organisms on the
skin surface so that they can easily
be removed by water
• Ideally, cleansers should not cause
skin irritation, disrupt the normal
pH of the skin surface, or cause
stinging or irritation of the eyes
•S
 elect mild lipid cleansers or
cleansing bars that have a neutral
or mildly acidic pH (pH 5.5-7.0) or
those that have been shown to have
minimal impact on the baby’s skin
surface pH
•C
 hoose cleansers with preservatives
that have demonstrated safety
and tolerability for newborns.
Preservatives are usually needed to
prevent the overgrowth of micro-
organisms that may occur with
normal use, but they may result in
skin irritation or contact dermatitis
4
Understanding newborn skin
The largest organ in the body, the
skin consists of three main layers: the
subcutis or inner-most fatty layer, the
dermis and the epidermis or outer layer.
The epidermis is continually regenerated
as new skin cells or keratinocytes form
in the stratum germinativum or basal
layer (McGrath et al, 2008). As the
keratinocytes move towards the surface
of the skin, they become flattened and
gradually die (McGrath et al, 2008).
The dead cells are called corneocytes
and make up the stratum corneum.
This cornified or ‘horny’ layer on the
surface of the skin is constantly shed
and replenished, and acts as a barrier,
preventing penetration by infectious
agents, irritants and allergens, while
regulating loss of water and nutrients
from the body (Stamatas et al, 2011).
The thinnest skin on a newborn is on
the face and as a result this is where
problems can first arise.
THE SKIN BARRIER IN INFANTS
Although full-term babies have a fully
functioning skin barrier that prevents
organ dehydration, their skin is not yet
mature and continues to change and
develop during the first year of life
(Stamatas et al, 2011; Telofski et al, 2012).
As a result, infant skin is not as resilient
as adult skin (Blume-Peytavi et al, 2012),
and its unique properties should be
taken into account in order to maintain
the integrity of the infant skin barrier
(Stamatas et al, 2010).
The barrier properties of the skin depend
greatly on the thickness and integrity
of the stratum corneum (Telofski et al,
FAST FACTS
•T
 here is a lack of expert consensus
concerning newborn cleansing
•T
 his lack of consensus has led to
uncertainty among midwives and
confusion among parents
•R
 andomised controlled trials
provide the best evidence for
the effectiveness and safety of a
treatment
•R
 ecently published randomised
controlled trials may influence
updated NICE guidelines on routine
newborn cleansing
2012). At birth the stratum corneum is
30% thinner in full-term infants than
in adults (Stamatas et al, 2010). The
stratum corneum continues to develop
during the first year of life, when there
are important changes in skin hydration,
surface pH and permeability to water
measured as transepidermal water loss
(TEWL) (Nikolovski et al, 2008).
Full-term newborns have relatively dry
skin, which becomes more hydrated than
adult skin during the first four weeks of
life (Telofski et al, 2012). At the same
time, although skin is more hydrated in
infants than in newborns, it has greater
TEWL and a lower concentration of
natural moisturising factors, surface
lipids and sebum compared to the skin
of newborns or adults (Stamatas et al
2011; Telofski et al, 2012). This means that
a skin cleansing regimen for newborns
must be able to remove unwanted
material from the skin without inducing
dryness, irritation, itch and barrier
damage (Stamatas et al, 2012).
The pH of any newborn cleansing regimen
is another important consideration
because of changes in the skin acidity
or ‘acid mantel’ of newborns (Stamatas
et al, 2011). At birth, the skin surface in
full-term newborns has a neutral pH of
6.34-7.5. This falls in the first two weeks
of life to become more acidic at pH 5.0,
similar to the skin surface pH of 4.0-6.7
found in adults (Telofski et al, 2012).
The acid mantel has multiple effects
on the skin, including a role in normal
skin shedding (desquamation), and
More high-quality evidence, together
with greater recognition of latest clinical
data in infant skin care, is essential to
resolve uncertainty among midwives and
confusion among women. Evidence from
well-conducted randomised controlled
trials has recently become available, but
any approach to newborn skin care must
also depend on an understanding of the
structure and physiology of newborn
skin.
maintenance of the permeability
barrier and the integrity of the stratum
corneum (Cork et al, 2006). Skin pH
is also important because of its role in
promoting the skin’s microbiome, the
diverse harmless or beneficial micro-
organisms that colonise the human
skin surface (Grice and Segre, 2011).
The microbiome is gradually acquired
from birth, and is thought to be critical
for the effectiveness of the skin’s
immune response against disease-
causing bacteria, and possibly for the
development of a healthy skin barrier
and systemic immune system (Capone
et al, 2010).
Infant skin differs from adult skin in its
structure, function and composition,
and needs appropriate, evidence-based
care to maintain the integrity of the skin
barrier (Telofski et al, 2012). At the same
FAST FACTS
(KOTTNER ET AL, 2013)
•T
 ransepidermal water loss (TEWL)
is the measurement of the amount
of water diffused through the
hydrated inner layers of the dermis
and epidermis to the skin surface
•T
 EWL is regarded as one of the
most important parameters for skin
barrier function
•A
 high TEWL level suggests that
skin barrier function is impaired
•A
 normal or reduced TEWL
indicates that the skin barrier is
intact or has recovered
 5

time, cleansing must effectively remove

unwanted substances from the skin to
maintain good health and hygiene in
infants (Telofski et al, 2012).

FAST FACTS
(TELOFSKI ET AL, 2012)

•F
 ull-term babies are born with
a functioning skin barrier that
continues to mature during the first
year of life

• Infant skin differs from adult skin

in its structure, composition and
functions

• In newborns, the skin barrier is

thinner than in adults, is more acidic
and more easily loses water

• Infant skin needs special care to

ensure that the health of the skin
barrier is maintained

The importance of effective skin cleansing

In infants, effective cleansing is essential
to remove substances such as milk, food,
nasal secretions and saliva that may
potentially cause irritation if left on the
skin (Stamatas et al, 2011). The infant’s
overall health also depends on keeping
the skin free of harmful bacteria in urine
and faeces that cause irritation and
may lead to infection if transferred to
the baby’s mouth (Stamatas et al, 2011;
Telofski et al 2012).
The techniques and agents used
to cleanse the skin have a role in
maintaining and restoring the skin
barrier (Fowler et al, 2013). Cleansing
may, however, have negative effects on
the stratum corneum depending on the
methods chosen (Fowler et al, 2013).
JUST SOAP AND WATER?
Soap is an effective cleanser, but it
also causes skin dryness and irritation
(Telofski et al, 2012). These negative
effects are likely to be due to the effects
of soap on skin lipids (fats) and pH,
which in turn impair the integrity of the
skin barrier (Ananthapadmanabhan et al,
2004).
The lipids surrounding the cells of the
stratum corneum play an essential role
in preventing loss of water and essential
blood minerals (electrolytes) through the
skin barrier (Feingold 2007). Although
any method of washing removes lipids
from the outer layers of the skin, loss of
lipids after washing with soap is greater
than after using either water or mild,
synthetic detergents (‘syndets’) (Blume-
Peytavi et al, 2012). The lipid content of
the skin is gradually restored over time,
but it is not recovered two hours after
washing with soap and such changes
in the lipid composition of the stratum
corneum may reduce skin barrier
function (Blume-Peytavi et al, 2012).
Soaps are typically alkaline, and have
been shown to increase the pH of infant
skin and disturb the acid mantel for
up to 30 minutes (Blume-Peytavi et al,
2012). Infant skin takes longer than adult
skin to restore the acid mantel (Blume-
Peytavi et al, 2012) and sustained pH
increases, such as those caused by
soap-based cleansers, have been shown
to adversely affect barrier function in
normal skin (Ali and Yosipovitich, 2013).
There is a correlation between high
TEWL and damage to the surface
structure of the stratum corneum
seen after washing with alkaline soap
(Ananthapadmanabhan et al, 2004). In
contrast, ‘syndets’ that are specifically
formulated for use in infants minimally
alter skin pH and deplete skin lipids, are
associated with a lower rate of TEWL
and are more able to maintain the
barrier function of the skin (Stamatas et
al, 2011).
Although water alone is recommended
for cleansing newborn skin, it is not an
effective cleanser because it cannot
dissolve faeces and other greasy
substances (Gelmetti 2001). Since these
substances are fat-soluble, they are
held on the skin by surface tension and
can only be removed by surfactants
(‘surface-acting’ agents) that break them
down into fine droplets that can then be
easily rinsed away with water (Gelmetti
2001).
Water is also a skin irritant, causing
itching and dryness (Tsai and Maibach
1999). It is rapidly absorbed into
the skin, especially through the still-
developing infant stratum corneum. This
hydrates the skin, but the effect is only
temporary since the added water quickly
evaporates through TEWL, leaving the
skin dryer than before (Ewence et al,
2011). When it penetrates the skin, water
may also increase the spaces between
the corneocytes of the stratum corneum,
impairing the integrity of the skin barrier
and allowing pathogens and allergens
through the skin (Ewence et al, 2011).
It is important to remember that tap
water does not just consist of H20—i.e.
two hydrogen atoms for every one
oxygen atom. It also contains dissolved
minerals such as calcium or magnesium
that determine whether the water is hard
or soft (Ewence et al, 2011). This in turn
influences the pH of water—i.e. whether
6

pH Scale
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Increasing Acidity Neutral Increasing Alkalinity

• The pH scale ranges from 0 to 14 and measures the acidity or alkalinity of a substance
• Pure (distilled) water has a neutral pH of 7
• A pH of less than 7 is acidic, and pH greater than 7 is alkaline

inherited predisposition and breakdown

FAST FACTS
(BLUME-PEYTAVI ET AL, 2012; CORK
ET AL, 2006; EWENCE ET AL, 2011;
STAMATAS ET AL, 2011)
•S
 oap is an effective cleanser, but
increases transepidermal water
loss and causes skin dryness and
irritation
•W
 ater alone is not an effective
skin cleanser and may also cause
dryness and itching
• Impairment to the skin barrier may
contribute to the development of
atopic dermatitis in susceptible
infants
•M
 ild, optimally formulated wash
products that do not alter skin pH,
cleanse infant skin effectively and
maintain the skin barrier
of the skin barrier due to adverse
environmental effects (Cork et al, 2006).
Several factors are associated with the
development of AD, but increasing use
of soap and detergents, especially with
hard water, has been cited as one of the
most important because of their effects
on the stratum corneum (Cork et al,
2009).
The stratum corneum is like a brick wall
in which the bricks (the corneocytes) are
surrounded by mortar (the lipid lamellae)
and are supported by iron rods (proteins
called corneodesmosomes). When an
infant is genetically predisposed to AD,
1a
FAST FACTS (EWENCE ET AL, 2011,
TELOFSKI ET AL, 2012)
•P
 ure (distilled) water has a neutral
pH of 7.0
•N
 aturally soft tap water generally
has a pH of 8.0-8.5
•T
 he pH of naturally hard water is
generally maintained at about 7.5
•F
 ull-term newborn skin has a
neutral pH of 6.34-7.5 at birth,
falling to a more acidic pH of 5.0 in
the first two weeks of life
1b

it is acid, alkaline or neutral—but both

hard and soft tap water is relatively more
alkaline than the acid surface pH of the
skin (Ewence et al, 2011, Telofski et al
2012).

Rinsing with even slightly alkaline tap

water can raise skin pH for several hours,
reducing the function of the acid mantel
and promoting breakdown of the skin
barrier (Ewence et al, 2011). Since the
skin is the body’s first line of defence
against harmful irritants and allergens,
impairment of the delicate newborn
skin barrier has been identified as an
important factor in placing susceptible
infants at risk of skin problems such as
atopic dermatitis (AD), also known as
atopic eczema (Cork et al, 2006).
ATOPIC DERMATITIS
Atopic dermatitis (AD) is an extremely
common, chronic inflammatory skin
condition that usually starts during the
first months of life (British Association
of Dermatologists 2013). The causes
are complex, but AD is thought to be
the result of an interaction between
1a & 1b source: CORK ET AL, 2006
the corneodesmosomes break down appropriate care of newborn skin may
prematurely below the skin surface have significant long-term implications
(Cork et al, 2006). In infants with AD, the for health (Bedwell and Lavender 2012)
stratum corneum resembles a brick wall and this highlights the need for suitable
in which the supportive iron rods have skin care regimens (Lavender et al, 2013).
rusted, leaving it more vulnerable to
the effects of the external environment.
When the stratum corneum is impaired—
for example, through the effects of
soap on skin lipids and pH—the skin
barrier can no longer prevent allergens
and infection from reaching the
dermis, leading to the inflammation
characteristic of AD (Cork et al, 2006).
Conversely, preservation or restoration
of a functional skin barrier may reduce
the risk or possibly the severity of AD
(Stamatas et al, 2011). As a result,

New evidence on infant cleansing
Until recently, there were no robust
clinical studies investigating the routine
cleansing of newborn skin. Small-scale
studies have in the past indicated that
specially formulated products are as well
tolerated as water alone when used to
cleanse newborns. It has, however, been
challenging to draw overall conclusions
because of differences in the studies’
participants, methods and outcome
measures.
A trial including 180 healthy infants
(aged from one day to one year) found
no significant differences between
a wash product and water alone in
outcomes such as swelling, redness and
irritation, dryness or scaling (Dizon et al,
2010). A second study randomised 64
healthy, full-term newborns (aged less
than 48 hours) to four groups: twice-
weekly bathing with wash gel, or cream,
or wash gel and cream, or water alone.
At the end of eight weeks, there was
significantly less TEWL at all studied
body sites in babies randomised to wash
gel and cream or cream alone compared
to those assigned to water alone (Garcia
Bartels, et al 2010).
Skin pH was significantly lower in
the wash gel group than in babies
randomised to water, an effect that
persisted until the eighth week of life
(Garcia Bartels et al, 2010). A higher skin
surface pH has been related to higher
rates of bacterial proliferation
and greater activity of proteolytic
enzymes that are detrimental to skin
barrier function (Blume-Peytavi et al,
2012). This has potentially important
implications for future skin health,
since studies have found that skin pH
is significantly raised in patients with
AD compared to that of controls with
healthy skin. This higher skin pH is seen
even in unaffected skin of patients
with AD, and can be expected to delay
recovery and facilitate breakdown of the
skin barrier (Cork et al, 2009),
LATEST EVIDENCE
In 2009 a European Round Table
consensus on newborn cleansing called
for further clinical research to investigate
the potential benefits of appropriate
cleansers (Blume-Peytavi et al, 2009).
This research is now available in two
large, investigator-led, randomised
controlled trials that confirm the
tolerability of some specially formulated
and robustly tested, mild and gentle
cleansers (Lavender et al, 2012; Lavender
et al, 2013).
Both trials were conducted by a
multidisciplinary team at Central
Manchester NHS Foundation Trust.
These studies compared the safety
of JOHNSON’S® Baby Top-to-Toe®
Bath and JOHNSON’S® Baby Extra
Sensitive Wipes on healthy newborn
skin, against water alone. The two trials
were funded by an educational grant
from Johnson & Johnson, who agreed
that the researchers would publish the
results of their studies regardless of
outcomes. Both trials were independently
designed and led by the researchers; this
included the trial design, data analysis,
interpretation of results and production
of the manuscript.
Given the lack of previous large, robust
randomised controlled trials, the design
of both studies was based on the
findings of a pilot randomised controlled
trial that included 100 healthy newborns
(Lavender et al, 2011). The results of
this study were used to determine the
number of participants needed to obtain
statistically significant results in the
larger trials and the validity of TEWL
as an outcome in newborns.
Babies and mothers participating in
both trials were recruited within 48
hours of birth. To avoid biasing the
results of either study, the babies were
randomly assigned to their treatment.
This was done through either computer-
generated telephone randomisation
(Lavender et al, 2012) or consecutively
numbered, sealed, opaque envelopes
held by the research manager at the
study hospital (Lavender et al, 2013).
In both randomised trials, the study
groups were similar in terms of maternal
characteristics, the babies’ gender,
feeding method and birth weight, and
the method of birth.
The aim of both studies was to
demonstrate that the products under
investigation had an equivalent effect—
i.e. were ‘non-inferior’—to usual care
with water and cotton wool. Outcomes
of the two studies were assessed by
research midwives who were unaware
of the babies’ allocated treatment. The
mothers also completed questionnaires
and diaries. It was not possible to ‘blind’
the mothers to their babies’ allocation
because of obvious differences between
the treatments under investigation.
7
WATER VERSUS WASH PRODUCT
(Lavender et al, 2013)
The first trial included 307 newborns
randomised to either bathing with a
wash product or water alone. The wash
product was non-inferior to water
alone on the primary study outcome of
TEWL at 14 days. There were also no
significant differences on secondary
outcomes, including changes in stratum
corneum hydration, skin surface pH, and
clinically observed dryness, redness or
excoriation.
FAST FACTS (LAVENDER ET AL,
2012; LAVENDER ET AL, 2013)
•N
 ew evidence is now available from
the two largest-ever randomised
controlled trials on skin cleansing in
healthy newborns
•A
 trial including 307 babies shows
that a certain mild and gentle,
pH-neutral, specifically formulated
and robustly tested cleanser can be
used safely on newborn skin
•A
 trial in 280 babies shows that
a certain wipe impregnated with
pH-neutral lotion is appropriately
designed for use on infant skin
and has been clinically tested and
proven safe even for newborns
•T
 he results of these two clinical
trials cannot be extrapolated to
demonstrate the efficacy and safety
of other infant cleansing products
The mothers’ overall satisfaction
was similar in the two groups, but
there were some difference in their
perceptions of their assigned treatments.
Mothers using the wash product were
significantly more likely than those
using water to report that their newborn
smelled good (p<0.001). Mothers in this
group who continued using the wash
product were also significantly more
likely to maintain the same bathing
regimen after the end of the study
(p=0.010 versus water alone).
WATER VERSUS BABY WIPES
(Lavender et al, 2012)
For the second study, researchers
recruited 280 newborns, who were
randomly assigned to have their nappy
area cleansed with a fragrance-free
baby wipe or cotton wool and water.
The wipes were equivalent to water and
8
cotton wool on the primary outcome of
change in skin hydration from within 48
hours to four weeks after birth. There
were also no significant differences
on the secondary clinical outcomes
of changes in TEWL, skin surface pH,
erythema, and the presence of microbial
skin contaminants or irritants at four weeks.
The assessing midwives reported
similar rates of nappy dermatitis at four
weeks in the two treatment groups.
However, mothers in the wipes group
were significantly less likely to report
nappy dermatitis than those in the water
Conclusions
When caring for newborn skin, it
is essential to balance the need for
effective cleansing with the preservation
of the skin barrier. NICE guidance is
a benchmark for advising healthcare
professionals on best practice, yet in
the case of infant skincare the current
guideline is informed by anecdotal
expert thinking and is now outdated
due to recent evidence provided by the
clinical trials discussed.
Randomised controlled trials are
essential to provide high-level evidence
to support midwives when parents seek
advice about cleansing their newborn.
The two recently published studies
discussed in this supplement are the
largest randomised controlled trials to
date to investigate cleansing practices in
healthy newborns—specifically the role
of a wash product and wipes specifically
formulated for newborn cleansing.
Since randomised controlled trials are
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group (p = 0.025). According to the
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might initially be given to the midwives’
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the experts in their babies’ skin in this
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EVIDENCE INTO PRACTICE
The findings of these two largest-
ever randomised trials to investigate
cleansing practices in newborns provide
widely accepted as the highest level of
evidence, the results of these studies
may influence future recommendations
from guideline developers such as NICE.
Such guidelines on newborn skin care
should also take into account research
on the adverse effects of soap on the
development of the skin barrier, and
draw on the results of randomised
controlled trials to provide specific
recommendations on the choice of
specially formulated, pH-balanced,
soap-free products.
Good practice guidelines are needed to
enable midwives to provide guidance
and support to parents, who will
ultimately choose on how best to
care for their baby’s skin based on
their personal preferences and beliefs
(Steen and Macdonald 2008). The
latest AWHONN guidelines provide
helpful advice for midwives to pass on
to parents who choose to use baby
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important evidence to support midwives
when asked for advice on newborn
cleansing. The results should also be
reassuring to parents who choose to use
specifically formulated products to care
for their babies’ skin. However, since the
findings of these two studies relate to
the products tested, it is risky to assume
that results would necessarily be the
same for other baby products currently
available to parents.
cleansers rather than water alone to care
for their baby’s skin.
The two randomised clinical trials
investigating the role of a specially
formulated wash product and wipes
in the care of newborn skin provide
important evidence and some
reassurance for both professionals and
parents, but their results cannot be
generalised beyond the products tested.
Since the publication of the latest NICE
guideline in 2006, expert debate and
research into effective infant cleansing
has progressed. Achieving the goal
of a truly evidence-based approach
to newborn skin cleansing depends
on greater recognition of the latest
clinical data and further high-quality
randomised controlled trials to support
professional advice and help to promote
informed choice for parents.
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