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R E S E A R C H A R T I C L E Open Access
Effect on skin hydration of using baby wipes to
clean the napkin area of newborn babies:
assessor-blinded randomised controlled
equivalence trial
Tina Lavender
1,3*
, Christine Furber
1
, Malcolm Campbell
1
, Suresh Victor
2,3
, Ian Roberts
4
, Carol Bedwell
1
and Michael J Cork
5
Abstract
Background: Some national guidelines recommend the use of water alone for napkin cleansing. Yet, there is a
readiness, amongst many parents, to use baby wipes. Evidence from randomised controlled trials, of the effect of
baby wipes on newborn skin integrity is lacking. We conducted a study to examine the hypothesis that the use of
a specifically formulated cleansing wipe on the napkin area of newborn infants (<1 month) has an equivalent
effect on skin hydration when compared with using cotton wool and water (usual care).
Methods: A prospective, assessor-blinded, randomised controlled equivalence trial was conducted during 2010.
Healthy, term babies (n = 280), recruited within 48 hours of birth, were randomly assigned to have their napkin area
cleansed with an alcohol-free baby wipe (140 babies) or cotton wool and water (140 babies). Primary outcome was
change in hydration from within 48 hours of birth to 4 weeks post-birth. Secondary outcomes comprised changes
in trans-epidermal water loss, skin surface pH and erythema, presence of microbial skin contaminants/irritants at
4 weeks and napkin dermatitis reported by midwife at 4 weeks and mother during the 4 weeks.
Results: Complete hydration data were obtained for 254 (90.7 %) babies. Wipes were shown to be equivalent to
water and cotton wool in terms of skin hydration (intention-to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5
(14.2), p = 0.47, 95 % CI -2.5 to 4.2; per protocol analysis: wipes 64.6 (12.4) vs. water 63.6 (14.3), p = 0.53, 95 % CI -2.4
to 4.2). No significant differences were found in the secondary outcomes, except for maternal-reported napkin
dermatitis, which was higher in the water group (p = 0.025 for complete responses).
Conclusions: Baby wipes had an equivalent effect on skin hydration when compared with cotton wool and water.
We found no evidence of any adverse effects of using these wipes. These findings offer reassurance to parents who
choose to use baby wipes and to health professionals who support their use.
Trial registration: Current Controlled Trials ISRCTN86207019
* Correspondence: Tina.lavender@manchester.ac.uk
1
School of Nursing, Midwifery and Social Work, The University of Manchester,
Manchester, UK
3
Central Manchester NHS Foundation Trust, St Mary's Hospital, Oxford road,
Manchester, UK
Full list of author information is available at the end of the article
© 2012 Lavender et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Lavender et al. BMC Pediatrics 2012, 12:59
http://www.biomedcentral.com/1471-2431/12/59
Background
There are major differences between the skin of a new-
born infant and an older child or adult. The mean Trans
Epidermal Water Loss (TEWL) has been shown to be
25 g/metre/hour in an infant compared with 7 in an
adult (p <0.0005) [1]. Skin barrier development in ba-
bies remains incomplete until around 12 months of age
[1]. This is important, as the thin skin barrier in an in-
fant [2] makes it vulnerable to skin diseases such as
atopic dermatitis and napkin dermatitis. It has been
reported that around 20 % of babies develop atopic
dermatitis [3,4] and 50 % develop napkin dermatitis [5].
These problems lead to concerns regarding skin care
routines, for parents and health professionals.
A number of factors contribute to the development of
napkin dermatitis. Prolonged skin contacts with urine
and faeces, occlusion of the skin by napkin use, skin
wetness and friction are key contributors. These factors
cause a rise in skin surface pH, increasing the activity of
proteases and lipases, thus hindering normal skin
microflora and disrupting normal skin barrier integrity
[6-9].
Whilst internationally it has been acknowledged that
appropriate cleansing practices are important [10], a
dearth of good quality clinical trials has led to variations
in baby skin care regimens around the globe, influenced
by tradition, culture and prior experience [10,11]. The
guidelines produced by the US Association of Women’s
Health, Obstetric and Neonatal Nurses recommend that
detergent and alcohol free wipes may be used if a clean
cloth and water are not available [12]. However, the
Postnatal Care guidelines in the UK [13] recommend
that wipes are not used for baby cleansing. Thus, in the
UK, the use of cotton wool and water is recommended
to parents.
Nevertheless, baby wipe usage has become progres-
sively more common for the cleansing of newborn ba-
bies’skin [14], despite the absence of good quality,
controlled, clinical research tackling their safety and effi-
cacy [14,15]. This may be because some parents do not
have confidence in water alone as an effective cleanser
[11]. One recent trial that did assess the impact of wipes
versus water on skin integrity offered some reassurance
of the safety of wipes but had limited applicability to
healthy newborns as the study sample comprised of high
risk neonates [16]. Trials that have compared wipes to
water in healthy infants have been methodologically lim-
ited by not being sufficiently powered to detect clinically
important differences [10,17]. Furthermore earlier trials
have studied children greater than one month old;
[14,17-20] this is relevant because of the ongoing devel-
opment of babies’skin, particularly in the first month of
life [21]. Despite the limitations of these studies, all
authors concluded that there was good skin tolerance of
wipes and no evidence of harm, even when used on
dermatitis skin [14].
Conversely, baby wipe-induced dermatitis in adults
has also been documented [15,22] causing some health
professionals to question the potential harm associated
with the use of baby wipes and promote water use only
[23].
However, water may not be an innocuous cleansing
agent. The damaging effects of water in adults have pre-
viously been highlighted [24]. In babies, water is rapidly
absorbed into the skin, even within 10 seconds [1]. This
has the potential to disrupt the barrier function by in-
creasing the space between skin cells. Furthermore, tap
water has a pH between 7.9 and 8.2 [24] which is more
alkaline than the pH of the skin in the weeks following
birth. Skin integrity can be compromised if the acid mi-
lieu of the skin is altered [25].
At present, there is little data from clinical trials that
can be used to assist parents and health professionals in
choosing between water and cotton wool and an appro-
priately formulated baby wipe, for cleansing the buttocks
for newborn healthy babies. This is an important issue
because of the readiness to use baby wipes among
mothers [11]. We therefore conducted a randomised
controlled trial to test the hypothesis that the use of a
cleansing wipe on the napkin area of newborn infants
has an equivalent effect on skin hydration when com-
pared with using cotton wool and water (usual care).
Methods
Study site and population
Between February and October 2010, we recruited
healthy newborn babies delivered at a large teaching
hospital in the North West of England, who were born
at 37 weeks gestation or more and were using disposable
nappies. Babies were excluded if they were admitted to
the neonatal unit; were receiving phototherapy; had limb
defects, non-traumatic impairment of epidermal integ-
rity or evidence of skin disorder at first visit. Babies with
a chromosomal abnormality or other syndromic diagno-
sis and babies going for adoption were also excluded.
The study followed Declaration of Helsinki protocols
and received ethical approval from North West 11
Research Ethics Committee, Preston, [16
th
October
2009] (REF: 09/H1016/118).
Recruitment and randomization
Pregnant women of potentially eligible babies were sup-
plied study information in the antenatal period via GP
surgeries, and community and hospital clinics. In the
postnatal period, the attending clinical midwives sought
verbal permission for a research midwife to approach
women who had been given prior information. Baseline
details were collected from all women supplying verbal
Lavender et al. BMC Pediatrics 2012, 12:59 Page 2 of 9
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and written consent, using a self-administered question-
naire. Family history of atopic eczema was established at
this stage (defined as at least one of father, mother, or
sibling, who has had a medical diagnosis of atopic ec-
zema and who has had topical steroid treatment). Inter-
preters were available for non-English speaking women.
Babies were randomized to a napkin cleansing regimen
using a specific type of baby wipe or cotton wool and
water. Randomisation was by computer-generated tele-
phone randomization, set up by a Clinical Trials Unit.
Randomization was stratified according to whether or
not there was a family history of atopic eczema. The
randomization sequence was in blocks of different sizes.
Intervention
We chose the JOHNSON’S Baby Skincare Fragrance
Free Wipe (Johnson & Johnson Ltd., Maidenhead SL6
3UG, UK), a product widely available in the market. The
cleansing system contained: coco-glucoside and lauryl
glucoside (non-ionic sugar derived surfactants). The
emollients contained: glycerin and glyceryl oleate. The
baby wipes also contained citric acid, which can have
dual functionality as pH adjuster and chelator. Addition-
ally, it was important to have a wipe with a pH close to
the skin pH (around 4.9 in this case); if the pH is too
low, this could be an irritant, if too high this would in-
crease the protease activity and inhibit lipid lamellae
synthesis in the skin barrier. The wipe contained 97 %
water and was free of alcohol, fragrance, essential oils,
soap and other harsh detergents; it was appropriately
preserved to prevent growth of microorganisms. The
wipe’s cloth material was a rayon viscose and polyester
nonwoven fiber blend, entangled in a matrix trough
water jets without chemical binders. This is designed to
reduce friction when wiped across the skin surface.
Participating mothers were given a cleansing demon-
stration by a Health Care assistant. All mothers were
advised to use nappies which were supplied by the
researchers for the duration of the study to ensure simi-
lar absorbency; a factor likely to influence skin hydra-
tion. Mothers were also advised to avoid using napkin
cream, other than that supplied by the research team as
a rescue treatment. Parents were provided with cotton
wool or baby wipes, according to their allocated trial
arm.
Assessment of trial outcomes
All initial measurements were taken in the hospital and
follow up measurements were taken in the home. Our
primary outcome measure was change in stratum cor-
neum hydration scores on the buttocks from first assess-
ment (within 48 hours of birth) to 4 weeks post birth,
using a Corneometer [26].
Secondary outcomes comprised change in erythema
measurements using a Mexameter (
W
MX 18) [27];
change in Trans Epidermal Water Loss (TEWL) using
an Aquaflux (AF200) [28], and change in skin surface
pH (using a pH meter). Measurements were taken on
the babies’buttocks at first assessment (within 48 hours
of birth) and 4 weeks post-birth. Anatomical markers
were used to ensure assessments were consistent. Two
measurements were taken at each site; mean scores were
used in analysis. Women were encouraged to cleanse the
babies’buttocks and replace the napkin 30 minutes be-
fore the assessments were conducted. If the baby soiled
the napkin within the 30 minutes prior to proposed as-
sessment, the assessment was delayed for a further 30
minutes. Swabs of the peri-anal area were also obtained
at 4 weeks to observe for between-group differences in
the presence of microbial skin contaminants and irri-
tants (Coliform bacteria and Candida species). Skin
measurement instruments were calibrated prior to re-
cruitment, during the recruitment period and following
the last follow-up assessment to prevent measurement
error.
Clinical measures included napkin dermatitis observed
at first assessment and 4 weeks post-birth by the re-
search midwife, and napkin dermatitis observed by the
mother daily from first assessment to 4 weeks post-birth.
A semi-structured diary was provided to all mothers;
this included a Diaper Area Rash grading scale [29,30]
to aid the process. A set of reference photographs
depicting the various levels of diaper rash were used
alongside the scale to ensure consistency in clinical
observations. Nappy cream usage was also recorded and
a rescue treatment was pre-specified (Natusan Nappy
Cream). Creams were weighed at the outset of the study
and following the last assessment as an accurate meas-
ure of usage.
Blinding
All measurements were made by research midwives
blind to treatment allocation. Women were asked not to
reveal their allocation to the midwife assessing the baby
in their home. Women were telephoned by the recruit-
ing midwife on the day of assessment and reminded to
remove visible signs of products (e.g. wipes or cotton
wool) prior to the assessing midwife’s arrival. When the
baby had a soiled nappy immediately prior to or during
the assessment, the assessing midwife left the room until
the baby had been cleaned.
Compliance
To optimize levels of compliance we maintained weekly
telephone contact with participating women; asked par-
ticipants to keep empty wipes and cotton wool packets
to determine usage; requested participants keep a
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cleansing activity diary; and supplied all wipes, cotton
wool, napkin cream and disposable nappies for the first
4 weeks of the study. We pre-specified that we would as-
sess the impact of any non-compliance on the primary
outcome using three definitions. Strict compliance was
defined as the non-use of any additional products on the
test site areas (or areas likely to contaminate the test
areas) throughout the study. Mostly compliant was
defined as no more than two occasions of additional
product use and non-use of additional products during
the week of follow up assessment. Non- compliance was
more than two occasions of additional product use and/
or the use of additional products in the assessment
week.
Analysis
Data were analyzed using SPSS (Release 16), following
double-entry of all data, with the statistician blinded to
the true treatment allocation.
The primary analysis was a comparison of stratum
corneum hydration score on the buttocks at 4 weeks be-
tween groups adjusted for the corresponding initial score
using analysis of covariance, with the stratification vari-
able (family history of atopic eczema) included as a fac-
tor. A 95 % confidence interval for the difference
between the groups in adjusted mean scores was com-
pared with the pre-determined equivalence region of
-5.8 to +5.8 to determine whether the interventions were
equivalent or not [31]. The main analysis was by
intention-to-treat (ITT); pre-planned secondary analyses
examined the effect of different protocol violations a
per-protocol approach in case violations brought out-
come scores for the water group closer to those for the
wipes group and increased the chance of a Type I error
(wrongly concluding equivalence) under ITT [31].
Secondary outcomes of skin pH, TEWL and erythema
at the buttocks were also compared by group at 4 weeks
using analysis of covariance to adjust for initial scores,
with family history of atopic eczema as a factor. These
were not equivalence analyses, and ITT was used for a
conservative analysis. Other secondary outcomes were
compared by randomized group under ITT: levels of
Coliform bacteria and Candida species in the peri-anal
area at 4 weeks using the Mann-Whitney test (distribu-
tions were highly skewed); midwife-observed napkin
dermatitis (5-point scale) at 4 weeks using the chi-
square test for trend; and maternal-observed napkin
dermatitis total score at 4 weeks from diaries (sum of 28
5-point scores) using the Mann-Whitney U test. Ken-
dall’s tau
b
correlation was used to measure the associ-
ation between highly skewed variables. Throughout, a
two-tailed p ≤0.05 was considered to be statistically
significant.
Sample size
From our best available data on newborns [32], the
mean stratum corneum hydration score at the thigh at
4 weeks post-birth was 58.0 (SD 14.9). We hypothesized
an equivalence region of ±10 %, -5.8 to +5.8, for the dif-
ference in mean scores in the two groups. For one-sided
2.5 % significance in each tail to give a 95 % confidence
interval for this difference, 140 per group were needed
at trial end. Because these data were not collected from
the buttocks, an internal pilot was overseen by our Data
Monitoring Committee to confirm the accuracy of the
trial size. Across 29 infants in the two groups, the pooled
standard deviation for hydration at the buttocks at
4 weeks was 12.0; to allow for underestimation in a
small sample, the upper 80 % confidence limit for this
was estimated as 13.7. For the same equivalence region
of -5.8 to +5.8, with one-sided 2.5 % significance in each
tail to give a 95 % confidence interval for the difference
in means between the groups [33] at 80 % power, we
required 119 participants per group at trial end. Assum-
ing a 10 % drop-out over 4 weeks, we aimed to recruit
at least 133 participants per group at baseline.
Results
Overall 280 babies were randomized, equally between
groups. The participation rate was 31.2 % (280/898). All
participants received their randomly allocated interven-
tion. The overall loss to first follow-up was 26/280
(9.3 %); 16 (11.4 %) in the wipes group and 10 (7.1 %)
in the water group. Participant flow can be seen in
Figure 1. One participant in the wipes group and two
in the water group discontinued their allocated inter-
vention by first follow-up. By first follow up, 107/124
participants in the wipes group were strictly compliant
with the study protocol, 8 were mostly compliant and 9
not compliant. In the water group, 111/130 participants
were strictly compliant, 10 were mostly compliant, 8
were not compliant and 1 was difficult to determine.
The groups demonstrated similar baseline characteris-
tics (Table 1). All initial skin assessment measures were
also comparable by randomized group (Table 2). Babies
in the wipes group had more frequent nappy changes
than those in the water group (wipes: 54/123 had nappy
changes at least every two hours (43.9 %); water: 40/
129 (31.0 %), χ
2TREND
= 4.83, df = 1, p = 0.028), but fre-
quency of bathing was the same in the two groups
(wipes: median number of baths per week = 3, range 0
to 14; water : median = 4, range 1 to 14, Mann-Whitney
U = 7379.0, p = 0.32). There was no significant difference
between the groups in the time interval between last
nappy change and assessment (wipes: median = 30 min-
utes, range 10 to 325; water: median = 30 minutes,
range 0 to 205, Mann-Whitney U = 7511.0, p = 0.53).
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There were no reported incidences of diarrhoeal illness
during the study.
Primary analysis
Mean hydration scores in the wipes group were similar
in all four analyses (Table 3). Mean scores in water
group were also similar, suggesting that non-compliance
was not affecting the hydration score. There was no evi-
dence of association between baseline hydration score
and group. Wipes were shown to be equivalent to water
and cotton wool in terms of skin hydration (Intention-
to-treat analysis: wipes 65.4 (SD 12.4) vs. water 63.5
(14.2), p = 0.47, 95 % CI for difference between adjusted
means -2.5 to 4.2; per protocol analysis: wipes 64.6
(12.4) vs. water 63.6 (14.3, p = 0.53, 95 % CI -2.4 to 4.2).
Ninety-five percent confidence intervals for all four dif-
ferences lay within the pre-specified equivalence region
from -5.8 to 5.8 (Figure 2). Follow-up was intended to
be at 28 days, but 32 follow-up skin assessments were
carried out from 32-38 days with another 10 at 39 days
or more, due to maternal availability. Per-protocol ana-
lyses examining the impact of excluding one or both
subgroups also found no differences between the groups,
with confidence intervals within the equivalence region.
Secondary analyses
Table 4 presents the secondary outcomes. We found no
evidence of difference in means between groups in skin
surface pH [5.93 (SD 0.58) vs. 5.65 (0.62), p = 0.36, 95 %
CI -0.1 to 0.4], TEWL [17.8 (7.0) vs. 19.0 (10.6), p = 0.49,
95 % CI -3.9 to 1.2] or log erythema [6.27 (0.14) vs. 6.30
(0.14), p = 0.18, 95 % CI -0.06 to 0.01].
There were few reports of napkin dermatitis by
mothers (over all 4-week diary entries, a complete ab-
sence of dermatitis was reported for 84 (37.5 %) babies
[49 wipes v 35 water]), or the midwives (at follow-up,
217 (85.4 %) babies were judged to have no rash and 27
(10.6 %) a slight rash). We did detect evidence of differ-
ence in napkin dermatitis scores between groups, as
reported daily by the mothers. Mothers of babies in the
wipes group were less likely to report napkin dermatitis
than those in the water group. This difference remained
regardless of whether we compared those diaries that
had complete entries (i.e. daily entries) (p = 0.025), or
those who had incomplete entries (i.e. some days miss-
ing) (p = 0.016). We found no significant difference in
napkin dermatitis scores between groups from the mid-
wife’s single observation. Agreement between the mother
and the midwife at follow-up appeared to be good.
Assessed for eligibility (n=898)
Declined to participate (n=618):
Preference for wipes (n=132)
Preference for water (n=168)
Wanted to use both (n=57)
Other (n=261)
Randomised (n=280)
Allocated to water group
(n=140)
Allocated to wipes group
(n=140)
Loss to follow up (n=10):
Withdrew (n=2)
Loss of contact (n=14)
Loss to follow up (n=10):
Withdrew (n=1)
Loss of contact (n=9)
Available for analysis (n=130)Available for analysis (n=124)
Figure 1 Participant flow during the study.
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Among the 72 mothers who were followed up just as
their diary ended, 57 (79.2 %) had 28-day scores that
agreed with the midwife’s score, 6 scored one grade
higher and 6 scored one grade lower. Among the 119
followed up within a day of their diary ending, 94
(79.0 %) agreed with the midwife, with 13 one grade
higher and 8 one grade lower. Among the 147 followed
up within two days of their diary ending, 114 (77.6 %)
agreed with the midwife, with 18 one grade higher and 8
one grade lower.
The time from the last napkin change to the follow-up
skin assessment was not correlated with the number of
colonies of enteric Coliform bacteria (Kendall’s tau
b
=
0.04, p = 0.37) or Candida species (Kendall’s tau
b
= -0.04,
p = 0.50), although the bacteria counts were themselves
correlated (Kendall’s tau
b
= 0.16, p = 0.002). We found no
evidence of difference between groups in the numbers of
Coliform bacteria [20000 (53-45250) vs. 4850 (168 to
119,500), p = 0.91] or Candida species [0 (0 to 0) vs. 0 (0
to 0), p = 0.18], in the peri-anal area. There was also no
evidence of difference in use of Natusan cream (rescue
napkin cream).
Discussion
When products such as baby wipes appear on the
shelves for purchase, an assumption is made that they
have been evaluated for safety and efficacy [11]. While
these aspects can be established through routine pre-
market evaluation and meet global regulatory standards,
many products do not undergo further clinical research
to assess the effects of the products on the infants’skin,
as we have reported. In our study, we adhered to the
same stringent guidelines as those recommended by the
U.K. Medicines and Healthcare products Regulatory
Agency [33] believing, like others [34], that products
used on babies should be subjected to the same gold
standard that is recognised for the use of medicines.
We report findings from the largest clinical trial of
healthy newborn babies and napkin cleansing. Using
specially formulated baby wipes had an equivalent affect
on hydration of the babies’buttocks as using water and
cotton wool. Furthermore there was no evidence of any
differences between the two cleansing regimens for any
of the additional skin assessments (skin surface pH, ery-
thema, trans epidermal water loss or microbial skin con-
taminants). This should reassure parents who choose to
use baby wipes of a similar formulation to those used in
this trial and to health professionals who support their
use.
Wipes contain different ingredients and have changed
notably over the last decade; the introduction of pH-
buffered wipes, in particular, has improved napkin area
care [35]. Those associated with contact dermatitis are
likely to be older formulations which contain alcohol,
sub-optimal surfactants and non-allergy screened fra-
grances. However, we only trialled one brand of wipe;
given the plethora of wipes available, with different for-
mulations, it would be important to conduct further
robust randomized controlled trials before any wide-
spread recommendation.
Although reports of severe napkin rash were few, there
were more reports of mild/moderate napkin dermatitis
by the mothers in the water group than in the wipes
group. There were no differences between the groups in
the midwives reporting. Whilst intuitively one may give
more credence to the midwives score, she only assessed
the babies’buttocks at two time periods, four weeks
apart. Conversely, the mother assessed the baby daily
and was most likely to know the minutia of their own
baby’s skin; the mother could therefore be seen as the
Table 1 Baseline characteristics of participants by
randomised group. Values are numbers (percentages)
unless stated otherwise
Characteristic Details Wipes Water
(n = 124) (n = 130)
Family history of
atopic eczema
Yes 44 (35.2) 49 (37.7)
Maternal age Mean (SD) 28.6 (5.5) 29.5 (5.5)
Maternal ethnicity White British 64 (51.6) 64 (49.2)
White other 7 (5.6) 7 (5.4)
Asian 25 (20.2) 25 (19.2)
Black 24 (19.4) 21 (16.2)
Other 4 (3.2) 13 (10.1)
Parity Primiparous 55 (44.4) 68 (52.3)
Multiparous 69 (55.6) 62 (47.7)
Birth mode Normal vaginal 84 (67.7) 88 (67.7)
Instrumental 25 (20.1) 22 (16.9)
Caesarean section 15 (12.1) 20 (15.4)
Baby’s gender Male 76 (61.3) 75 (57.7)
Female 48 (38.7) 55 (42.3)
Birth weight Mean (SD) 3.404 (0.5) 3.462 (0.5)
Feeding method Breast 91 (73.4) 95 (73.1)
Bottle 20 (16.1) 23 (17.7)
Mixed 13 (10.5) 12 (9.2)
Table 2 First skin assessments by randomised group
Measurement Wipes (n
1
= 124) Water (n
1
= 130)
Hydration (arbitrary units) 40.0 (12.6) 38.8 (12.3)
Erythema (arbitrary units) 572.0 (104.2) 592.4 (105.1)
Log erythema (arbitrary units) 6.3 (0.2) 6.4 (0.2)
Skin pH 6.0 (0.6 %) 5.9 (0.6 %)
TEWL (g/m2/h ) 12.4 (4.0 %) 13.0 (4.1 %)
1
occasional missing values due to equipment malfunction.
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expert. The value of parental assessment has been
reported in atopic eczema where measurements made
by the patient/carer using POEM correlated very well
with clinical measurements made by the dermatologists
[36]. The midwife was blind to the allocation but the
mother was not. This may have influenced reporting;
however, there is no clear rationale for why mothers in
the usual care group (water) would report more nega-
tively, especially as compliance was good. Napkin
dermatitis was a secondary outcome and therefore the
findings should be viewed cautiously. However, napkin
dermatitis is the most common dermatologic disorder of
infancy [37]; given the anxiety that this creates for par-
ents, this is an area that warrants further investigation.
The absence of robust evidence from randomized con-
trolled trials has meant that traditional practices and
consensus opinions have dictated cleansing practices
[10,11]. Our findings should be used to provide parents
and health professionals with evidence based informa-
tion, from which they can select the most appropriate
method of napkin cleansing.
Our findings add to current debates [11,34] regarding
the most appropriate cleansing regimens for babies.
Uniquely, we have conducted the only adequately pow-
ered trial comparing wipes with cotton wool and water
on healthy newborn infants. Importantly, our trial had a
pragmatic design, which enabled us to assess the impact
of wipe usage by those who normally use them (i.e. par-
ents), in an environment that they are normally used.
This latter point is particularly relevant given the mobil-
ity of wipes and the potential storage options (e.g.
shelves, handbags, perambulators). We did, however,
Table 3 Comparison of primary outcome measure (hydration score on the buttocks) at follow-up by randomised group
under intention-to-treat (ITT) and per-protocol (PP) analyses
Analysis Wipes (n = 123)
Mean (SD)
Water (n = 126)
Mean (SD)
Group effect P-value 95 % CI for difference in
adjusted means
ITT 65.4 (12.4) 63.5 (14.2) 0.470 −2.5 to 4.2
PP
Compliant with allocation (n= 122) 64.6 (12.4) (n = 123) 63.6 (14.3) 0.526 −2.6 to 4.2
Mostly compliant with protocol (n = 114) 64.9 (12.5) (n = 116) 63.2 (14.1) 0.427 −1.9 to 5.0
Strictly compliant with protocol (n = 106) 65.3 (12.0) (n = 107) 63.2 (14.1) 0.440 −1.6 to 5.5
Figure 2 Equivalence analysis by confidence interval for difference in mean hydration score at 4 weeks between groups.
Lavender et al. BMC Pediatrics 2012, 12:59 Page 7 of 9
http://www.biomedcentral.com/1471-2431/12/59
only access women in one hospital setting. Nevertheless,
this setting supports women from a diverse range of
socio-cultural backgrounds and our data reflect this.
Findings from this study are therefore likely to be trans-
ferable to other settings.
Our trial observed outcomes at 4 weeks post birth,
providing information on the impact of water and one
type of wipe on skin integrity in the early postpartum
period. Longitudinal studies would be required to assess
the impact of these cleansing regimes with continued
use. We do not know whether wipes using other formu-
lations would have comparable results to ours; further
trials are required.
Conclusions
Our study is the largest clinical trial of healthy newborn
babies and napkin cleansing. We provide valuable data
which demonstrated that using specially formulated baby
wipes had an equivalent affect on hydration of the ba-
bies’buttocks as using water and cotton wool. These
findings should be used by parents when choosing their
preferred napkin cleansing routine. Health professionals
should use this information to support parental choice.
Competing interests
All authors have completed the Unified Competing Interest form at
www.icmje.org/coi_disclosure.pdf (available on request from the
corresponding author) (URL) and declare: financial support for the submitted
work from Johnson and Johnson; TL, CF, CB, SV, MJC, IR have received a
research grant for this submitted work and other ongoing research (TL, CB,
MJC). TL, MJC, CB have received honorariums for acting as expert advisors to
Johnson and Johnson.
This study was funded by Johnson and Johnson, however, this is an
investigator led trial; the trial management team (TL, MJC, CB, SV, IR, CF),
made all decisions regarding trial design, execution, analysis, interpretation
and publication. Only the trial management team and data monitoring
committee had access to the data.
Acknowledgements
We thank the staff of Central Manchester NHS Foundation Trust, in particular
the research midwives, Lois Rowlands, Sue Woods, Charlotte Jones and
Helen Millar. We thank all of the participants who gave up their valuable
time. We also thank our Data Monitoring Committee members, Prof James
Mason (Chair), Dr Kevin Hugill and Mrs Annette Briley. We are also grateful to
Marie Goldrick (technician) for analysis of peri-anal swabs and to Carolyn
Lund who reviewed a draft of this paper.
Author details
1
School of Nursing, Midwifery and Social Work, The University of Manchester,
Manchester, UK.
2
School of Biomedicine, The University of Manchester,
Manchester, UK.
3
Central Manchester NHS Foundation Trust, St Mary's
Hospital, Oxford road, Manchester, UK.
4
Faculty of Life Sciences, The
University of Manchester, Manchester, UK.
5
Academic unit of Dermatology
Research, The University of Sheffield Medical School, Sheffield, UK.
Authors’contributions
TL and MJC conceived the idea for the study. TL, MJC, MC, CF, CB, SR, IR
designed the study. CF co-ordinated the data collection. MC conducted the
analysis. All authors interpreted the findings. TL wrote the first draft of the
paper. All authors approved the final draft of the paper. TL is guarantor of
the paper.
Funding
This is an industry funded study, however the trial was investigator led. The
trial management team ran the study independently of the funders, from
conception to completion; this included trial design, management, data
analysis, interpretation of results and production of this manuscript. The
funders have not had access to the actual data.
Received: 26 August 2011 Accepted: 1 June 2012
Published: 1 June 2012
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doi:10.1186/1471-2431-12-59
Cite this article as: Lavender et al.:Effect on skin hydration of using
baby wipes to clean the napkin area of newborn babies: assessor-
blinded randomised controlled equivalence trial. BMC Pediatrics 2012
12:59.
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