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S
av
ingl
iveswit
h4
.0%
chlorhex
idin
ec
leans
ingof
the
umb
ilica
lco
rd
Luke
C.
Mu
llany,
PhD
,MHS
Assoc
iateProf
essor,
Jo
hns
Hop
kinsU
nivers
ity
(lm
ullany
@jhsp
h.e
du
)
Joha
nnes
burg,
-Apri
l2013
-
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Infect
ionrepres
entsasignificantca
use
ofneonatalmor
talityinlo
wresource
settin
gs
Exposuretopathogensis
highatbi
rth
andim
mediatepostpartum
Umbilicalcordvesselsareopenfor
24-
48ho
ursafterb
irth
Stumpisrapidlycolonized
Infec
tionan
dum
bilica
lcord
-
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TopicalAntisepticsan
dtheCord
~50yearsago:n
earlyunive
rsaluseof
topica
lantisepticsinfacilitiesofhigh
incom
ecountries
~25-40yearsago
:MANYstudieson
topica
lantisepticstoexamine:
Topicalantisepticsreduceexposuretopathogens
Less
directeviden
ceforreductionininfection/
death
Bylat
e1990s,largeliterature,
butalmost
NONE
fromplaceswithhighinfection
risk
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WHOGu
idelines
Recognizingalackofclea
revidence,
WHO
provided3keyrecommendations:
1.
Prom
otekeepingthecor
dclean/d
ry
2.
Topicalantisep
ticcouldbeused
whereinfection/exposureriskishigh
3.
Rese
archneed
edforopt
imal
guidelinesforhighrisks
ettings
*WHO.
Careoftheumbilicalcord.
WHO.
Genev
a,
1998.
WHO/RHT/MSM98
.4
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Why
Ch
lorhexi
dine
?
Broad
spectrum
antisepticsolution
Readilyavailable,worldwide
Excellentsafety
record
Superiortoman
yotherch
oicesfor
reduc
ingcordp
athogens
WHO
ModelListofEssentialMedici
nes
forco
rdcleansing
Evide
nceforreductionof
mortality
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O
verv
iew
an
dPoo
led
Ana
lysis
ofCHX
Tria
ls
-
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SarlahiDistrict,
Nepal:2002-2006
Mullanyetal,Lancet2006
Sylhe
tDistrict,Banglades
h:2007-20
09
Arifeenetal,La
ncet2012
Sindh
Province,
Pakistan:2008-2009
Soo
fietal,Lancet2012
SAsiaCHXCord
Clean
sing
Tria
ls
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Exclusion
No
tmet
within
10days
after
birt
h
No
tmet
within
7days
after
birt
h
No
tmet
within
3days
after
birth
Con.
an
oma
lies
Ove
rallDes
ignand
Contex
t
Instu
dyarea,
attimeo
fs
tudy
Nep
al
Bangla
des
h
Pak
istan
OverallNMR
32/1
000
36/1
000
30/
1000
%HomeBirths
92%
88%
80
%
No.
Clusters(av
gsize)
413(700)
133(4
000)
187(
1000)
Eligibility
Allliveb
irths
in
study
area
Allliveb
irths
in
study
area
Alllive
births
in
studyarea
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In
terven
tion
Pro
vide
d
Bangla
des
h
Pak
istan
ComparisonGroup
InterventionGroups
CHXConcentra
tion
Nep
al
Dry
Cor
dCare
1.
Mu
ltip
leCHX
2.
Soap/
H2
O
4.0%
Dry
Cor
dCare
1.
Mu
ltip
leCHX
2.
Single
CHX
4.0
%
FreqofMultiple
App
1,2,3,4,
6,8,1
0
1,2,3,4
,5,6,7
InterventionPro
vider
Loca
lpro
jec
t
staff
Localp
rojec
t
sta
ff
Dry
Co
rdCare
1.
Multip
leCHX
2.
Hand
Was
hing
3.
HW+
CHX
4.0%
Da
ily
for
14days
TBAtocare
taker
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Co-int
erven
tion
s,
Ou
tco
mes,
SS,
FU
Nep
al
Bangla
des
h
Pak
istan
PrimaryOutcom
es
Morta
lity
Ompha
litis
Morta
lity
Omph
alitis
Mor
tality
Omp
ha
litis
SampleSizeTotal
15,1
23
29,7
60
9,741
SampleSizePe
rGroup
~5050
~9,9
00
~4,8
50
FollowUpDays
1,2,3,4,6,
8,1
0,1
2,
14
,21
,28
1,3,6,9,1
5,2
8
1,3,5,
7,1
4,2
8
Basicinterventionsto
allbabies/moth
ers
CDK
,Fe/FA
,TT
,
promot
iono
f
ANC/E
NC
,
CDK,F
eFA
promotio
no
fTT
,
ANC,
ENC
Bas
icco
mpo
f
ENCaspromo
ted
by
MoH
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Impac
ton
All-Cause
Morta
lity
Nepal
24%lowermortalitya
t28days(mu
ltipleCHX)
34%lowermortalityifinitiatedwithin24hours
NoimpactofSoap/H2
Ocleansing
Banglade
sh
20%lowermortalitya
t28days(sin
gleCHX)
6%lowermortalityat
28days(multipleCHX,
NS)
Strongevidenceofim
pactamongp
retermbabies
Pakistan
38%lowermortalitya
t28days(CH
Xgroups)
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Prel
iminary
Poo
led
Ana
lys
is
M
ORTALITY:
AnyCHXvs
.NoCHX
Study
Overa
ll
0.7
7(0
.63
,0.94)
RR(95%
CI)
RR(95%
CI)
1
.5
.75
1.2
Nepal
0.7
6(0.5
8,1.
00)
Bangladesh
0.8
8(0.7
4,1.
04)
Pakistan
0.6
2(0.4
5,0.
85)
M
ORTALITY:AnyCHXv
s.
NoCHX
23%re
duction
inmortalityamong
thosereceivinginte
rvention
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Impac
ton
Cord
In
fec
tion
Inallst
udies
Multiple
CHXreducedcordin
fection
Nepal:
33%75
%reduction
Bangladesh:
15%45
%reduction
Pakistan:
40%50
%reduction
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Poole
dAnalysisCordInfection
SevereInfectio
n:AnyCHX
vs.
NoCHX
Pakistan
Study
Nepal
Banglades
h
0.5
1(0.1
8,
1.45
)
RR(95%CI)
0.2
5(0.1
3,
0.51
)
0.5
5(0.3
0,
1.01
)
0.5
1(0.1
8,
1.45
)
RR(95%CI)
0.2
5(0.1
3,
0.51
)
0.5
5(0.3
0,
1.01
)
1
.1
.25
.5
1
1.5
C
ordInfectio
n:AnyCHX
vs.
NoCHX
0.4
1(0.2
4,
0.69
)
Overall
59%
reductio
ninser
iouscor
d
infect
ionamo
ngthosereceiving
chlo
rhexidin
e
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Exposur
eo
fthecords
tum
p
Loca
ls
ignso
f
infec
tion
No
loca
ls
igns
ofinfe
ction
Dea
th
B
loo
ds
tream
infec
tion
No
bloo
ds
tream
infec
tion
Surv
iva
l
Surv
iva
l
Mu
llanye
ta
l,PIDJ
,2009
Corde
xposure
an
dcaus
alpa
thw
ays
-
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Sum
maryo
fMo
de
ofActio
n
0
D
ay
7
14
Preventcontinu
ed
exposurew
ith
repeatapplicatio
ns
Co
lon
iza
tion
ofthepa
ten
t
vesse
ls
Seps
is
Dea
th
Visible
infec
tion
Sepsis
Dea
th
Earlyapplications
protectduring
patentperiod
CHXApp
lica
tion
Mortality
Risk
HIGH
MEDIUM
LOWER
Primary
benefitof
earlyCHX
clea
nsings
Additionalbenefit
ofm
ultiple
cleansing
Segre
J,S
ep
tem
ber
2011
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CommonQuestions/Though
ts
Ischlo
rhexidine
safe?
Yes,chxhasbeenincommo
nusefor60
years,andhase
xcellentsafe
tyrecord.No
repo
rtedadverseeventswhe
nusedon
umb
ilicalcord
Ischlo
rhexidine
readilyav
ailable?
Yes,oneofthemostcommo
nlyusedtopical
antisepticsinthe
world
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Puttingchlorhex
idineonthecordmight
delayseparationtime
TRU
Eanyactionthatkeep
sthecord
clea
ner,willd
ela
ycordseparationtime
This
isimportantfromaprog
rammatic
experienceandforshapinga
cceptance
Wha
tismoreimportant?
savinglivesand
reducinginfec
tionOR
Havecordfalloffonday5inst
eadofday6?
CommonQuestions/Though
ts
-
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Doesn
tcleanan
ddrycord
carework
justas
well?
Allthreeoftheb
igtrialstellu
stheopposite
Therearenocommunity-bas
edrandomiz
ed
trialsofpromotionofdryandcleancord
prac
ticesshowingimpacton
mortality
Why
not?Becausekeeping
cordcleana
nd
avoidingpathogensisveryd
ifficult(~80%
-
90%
ofcordscolonizedimmediately)
CommonQuestions/Though
ts
-
7/28/2019 Mullany: Saving Lives With 4% Chlorhexidine Cleansing of the Umbilical Cord
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Wewo
ntbenefitfromchlo
rhexidine
becaus
eharmful
practicesarenolonger
commo
n
Not
necessarilytrue.
Thecordstumpisstill
exposedtopathogensthroug
hroutineho
me
and
facilitypract
ices
Amo
ngbabiesw
herecaretakersfollowed
suggestedcleanedcordpra
ctices,
chlo
rhexidinestillreducedinfectionand
mortality
CommonQuestions/Though
ts
-
7/28/2019 Mullany: Saving Lives With 4% Chlorhexidine Cleansing of the Umbilical Cord
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Thisint
erven
tionwou
ldon
lyhe
lpba
bies
bo
rn
athome
Nottrue.
Facilitybo
rnbabiesinth
eBangladesh
and
Nepaltrialshad:
Lo
wermortalityifth
eygotchlorhexid
ine
Lo
werriskofcordinfection
Reducedcolonizationofthecord
andsamerelatio
nshipbetweencordseparationtim
eand
co
rdcare,asseen
inhomebirths
facilitiesalsostruggletoachievehygienicpractices
babiesaredischargedintosameenvironmentas
home-bornbabies
CommonQuestions/Though
ts
-
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Com
monQ
ues
tion
s/Po
int
s
Cantwejustusealcohol,
gentianviolet,
oriodin
e?
Alco
holnotgood
forpreterm
skin
Gen
tianvioletno
tsufficiently
bacteriocida
l
Iodinetooeasily
absorbedth
roughskin
Allh
ighqualitye
videncefrom
community-
settingsisbased
onchlorhex
idine
-
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ThepriorWHOre
commenda
tionwas
clean/drycordcare!
Whe
nmakingthe
recommenda
tion,
WHO
reco
gnizedthat:
Evidencefromhig
her-riskpopulationswasnotav
ailable
M
oreresearchwa
sneededtodefineoptimalcordcare
Topicalantiseptic
suchaschlorhexidinecouldbe
used
ifexposuretothe
cordwaslikely
Asp
ublichealthp
rofessionalsweareobligatedto
updaterecommen
dationsandpoliciesifevid
ence
eme
rgesthatwarrantschange
CommonQuestions/Though
ts
-
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Promo
tionofchlorhexidineconflicts
withou
rprevious
messages..
Mes
sagescanb
eshapedto
fitconsistently
with
promotiono
fcleancord
care
Topicalchlorhex
idinecanbe
promotedasa
tooltohelpcare
takersachie
veacleanc
ord
Eve
nifconflict,
thisisNOT
avalidrea
son
forINACTION,iftheeviden
ceexists.
CommonQuestions/Though
ts
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Final
Thoug
hts
CHXissafe,acceptable
CHXcanhavev
ariousformulations,
packa
ging,
distributionm
odels
Clean
singshou
ldbeginasearlyas
possi
bleafterb
irth
CHXcordclean
singcans
avehundr
eds
oftho
usandsoflives,atv
erylowco
st
-
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P
artners
an
dSu
pport
Nepal:
NNIPS,
JHU,
IOM-TribhuvanUnive
rsity,
NICHD,
Bill&
Melinda
GatesFound
ation,
USAID,
Proctorand
Gamble
,MoHP,
NepalFamilyHealthProject
Banglade
sh:
MoHFW
,ICDDR,B,J
HU,
Shimantik,
DSH,
SNL/S
ave
TheCh
ildren(USA),USAID,
ThrasherResearch
Fund
Pakistan:
AgaKh
anUniversity,
JohnSnowIn
c,
PakistanM
oH
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CHXre
duc
escolo
niza
tion
Largereduc
tionsin
colonization
duringthe
periodofop
en,patent
bloodvesse
ls
Multipleclea
nsing
sustainsthe
reduction
throughfirst
weekoflife