Journal club discussion Sep

2014
Jegen Kandasamy MD
PGY-6, NPM
In the NICU rates of healthcare associated infections are at least as high as
25%
Several studies have shown that skin underneath rings is more
heavily colonised than comparable areas of skin on fingers without
rings.
Wearing rings increases the carriage rate of gram negative bacteria
and enterobacteriaceae on the hands of HCWs.
Hand hygiene policies and education should include a section on
appropriate jewellery to be worn in the workplace.
The consensus recommendation from WHO is to strongly
discourage the wearing of finger and wrist jewellery during
healthcare
The wearing of a simple flat band during routine care may be
acceptable, but in high risk settings all rings or other jewellery
should be removed
On average each neonate or his or her immediate environment was
touched 78 times per shift.
Is hand hygiene alone sufficient?
Waters et al, Clin Infect Dis, 2004
To characterize the molecular epidemiology of gram-negative bacilli (GNB)
causing infections in infants and associated with carriage on nurses' hands
after hand hygiene was performed
Overall, 58% of infections were caused by unique strains not cultured from
other infants or nurses, and 31% of infections were part of unrecognized
molecular clusters
In contrast, only 9% of strains that caused infections were cultured from
nurses' hands
These data suggest that practices in addition to hand hygiene are needed to
prevent horizontal transmission of GNB in the NICU
Cohen et at, Pediatr Infect Dis J, 2003
Despite appropriate hand hygiene cultures from the hands of medical staff
yield microbes more than 50% of the time
Standard hand hygiene lowers the number of microbes on HCPs hands
and eliminates transient flora, but permanent flora may persist





Is hand hygiene alone sufficient?
Pessoa-Silva, Infect Control Hosp Epidemiol,
2004
HCWs who did not wear gloves acquired, on average, 24.5 CFU/min as compared with
-1.9 among those who did
Previous studies
Ng et al, ADC FN edition, 2004
To assess the incidence of late onset sepsis and NEC in
VLBW infants in two 36 month periods using two hand
hygiene protocols: conventional handwashing (HW; first 36
month period); an alcohol hand rub and gloves technique
(HR; second 36 month period)
Retrospective review of period prior to institution of new
hand hygiene protocol
ABHR, glove, ABHR for gloves
The introduction of the HR protocol was associated with a
2.8-fold reduction in the incidence of LOS, and also a
significant decrease in the incidence of MRSA septicaemia
and NEC in VLBW infants
Study premise
Preventing infections is critical to improving
rates of survival without neurodevelopmental
impairment and decreasing duration of
hospital stays and costs in this population
Although hand hygiene infection control and
prevention measures have been the topics of
multiple epidemiologic and retrospective
studies, they have not been subjected to
randomized clinical trials in the NICU
JAMA Pediatrics
Glove Use to Prevent Infections in
Preterm Infants
Kaufman DA, Blackman A, Conaway MR, Sinkin RA. Nonsterile
glove use in addition to hand hygiene to prevent late-onset
infection in preterm infants: randomized clinical trial. JAMA
Pediatr. Published online August 11, 2014.
doi:10.1001/jamapediatrics.2014.953.

Study Objective
To determine if non-sterile glove use after hand
hygiene before all patient and intravenous
catheter contact, compared with hand hygiene
alone, prevents late-onset infections in preterm
infants.
Hypothesis: Glove use + hand hygiene will
decrease incidence of LOS and NEC compared to
only hand hygiene
Objective of the study
Study Design
Prospective, single-center, randomized clinical trial.
Infants randomized to into one of the two groups using block
randomization with randomly varying block sizes of 2 and 4
Minimum duration of 4 weeks after birth, extended until patient no
longer has venous access (central or peripheral)
If lines were removed and subsequently required in future infant
reassigned to original group

Setting
Neonatal intensive care unit with 50 bed spaces divided among 7 pods

Participants
Birth weight <1000 g and/or gestational age <29 weeks.
<8 days old.
175 eligible infants, of whom 120 were enrolled.

Methods
Methods
Independent of group assignment, all health care
professionals
followed the 5 moments of hand hygiene from the World Health
Organization guidelines

for hand hygiene in health care
used nonsterile gloves for contact with body fluids or when
accessing arterial lines
used sterile gloves for aseptic procedures
Group B
Hand hygiene was defined as using alcohol hand rub or washing
hands with antimicrobial soap (eg, 2% chlorhexidine gluconate)
Group A: Group B intervention plus use of non-sterile
gloves
No mention of ABHR use after donning non-sterile gloves
Methods
Study intervention
The study intervention was nonsterile glove use after hand hygiene
(group A) or hand hygiene alone (group B) prior to all patient, bed,
and/or catheter contact.
Signs were placed on a stand at the bedside of all enrolled patients
(with a box of gloves if in group A) indicating group assignment and
protocol.
Intervention was specified to be performed during all contact with the
patient, inside the bed area, and with all central and peripheral
venous catheters.
Contact with central and peripheral catheters was defined as
whenever there was catheter contact and when making or breaking a
connection with the hub when
giving medications or flushes
changing tubing
accessing an injection port
adding a device
Methods
Additional infection control and prevention practices in their NICU
included
a CLABSI bundle for placement, maintenance, and removal of
catheters;
fluconazole prophylaxis for all infants who weighed less than 1000 g at
birth and/or had a gestational age of less than 28 weeks, or any infant
with NEC or gastroschisis;
antibiotic stewardship including limited use of third- and fourth-
generation cephalosporins and carbapenems;
limited use of postnatal corticosteroids, histamine H
2
receptor
blockers, and proton pump inhibitors;
weekly changing of all nasogastric and orogastric tubes.
All patients with NEC in both groups were placed in contact
isolation in which gowns and nonsterile gloves were used while
patients were receiving antimicrobials.
Outcomes
Primary
1 episode of late-onset (>72 hours of age) infection in the
bloodstream, urinary tract, or cerebrospinal fluid or
necrotizing enterocolitis that was treated with antibiotics
NEC was stage II or greater according to modified Bells
criteria
Secondary
Length of hospital stay
Infection-related outcomes
Mortality
Other neonatal morbidities
Cost of hospitalization

Statistical methods
Sample size calculation
Sample size of 120 infants
Study would have a 2-sided type I error rate of .05 or less and at least
80% power to detect an absolute difference of 25% in the cumulative
incidence of late-onset infection, including NEC, between the 2 groups
Given a pretrial incidence of 60% based on local and national data
Statistical methods
The
2
test was used to compare categorical outcomes between
groups
The nonparametric Mann-Whitney test was used to compare
continuous outcomes
Poisson regression using the appropriate number of days (line days or
study days) as the offset was used to compare the groups with respect
to rates per 100 days.
Methods

Limitations
Single-center study and may be affected by local infection
control practices.
Sample size was based on a higher incidence of infections
than were observed in the control group, so it was
underpowered for the primary outcome.
Aim of study was to have >90% compliance with hand
hygiene rates.
Parents had the choice to use gloves or not use gloves if
their child was randomized to group A (group with
nonsterile glove use after hand hygiene).
There is a possibility that if hand hygiene, glove use by
parents, and study protocol compliance were higher,
infection rates may have been lower in 1 or both groups.
Results
Results
Results
Difference in
Proportions
Between Groups
With 95% CIs
Comment
Nonsterile glove use after hand hygiene prior to patient
and catheter contact is associated with fewer gram-
positive bloodstream infections (BSIs) and central line
associated bloodstream infections (CLABSIs) in this
group of preterm infants.

Number needed to treat:
To prevent 1 gram-positive BSI is 6.
To prevent 1 possible CLABSI is 7.


Comment
In addition to the Centers for Disease Control and
Prevention definition of CLABSI, we also evaluated
possible CLABSIs defined as detection of growth from 1
blood culture of any organism, including coagulase-
negative Staphylococcus, and the presence of a central
catheter in the absence of another source.

We included this definition because asymptomatic BSIs,
defined as growth in 1 blood culture and treated, even
when caused by coagulase-negative Staphylococcus
organisms, are associated with increased
neurodevelopmental impairment and white matter
injury in preterm infants.
Comment
Retrospective studies have demonstrated an association with the
addition of glove use after hand hygiene in preterm infants and
other patient populations.
Very low-birth weight infants: Decreased BSIs and necrotizing
enterocolitis in preterm infants with birth weight <1500 g; this study
had an additional step of applying alcohol hand rub to the gloves.
1

Intensive Care Units: Glove use after hand hygiene during respiratory
syncytial virus season compared with the other months during an 8-
year period in a childrens hospital was associated with fewer BSIs and
CLABSIs in the neonatal intensive care unit, pediatric intensive care
unit, and pediatric bone marrow transplant unit.
2



1. Ng PC, Wong HL, Lyon DJ, et al. Combined use of alcohol hand rub and gloves reduces the incidence of late onset infection in very low birthweight infants. Arch Dis Child Fetal Neonatal
Ed. 2004;89(4):F336-F340.
2. Yin J, Schweizer ML, Herwaldt LA. Pottinger JM, Perencevich EN. Benefits of universal gloving on hospital-acquired infections in acute care pediatric units. Pediatrics. 2013;131(5):e1515-
e1520.

Comment
This readily implementable infection control measure may
result in decreased infections in high-risk preterm infants.