Primary ObjectiveTo determine the prevalence of respiratory viral colonization/infection in pre-term born neonates during hospitalisation.Secondary Objectives1. To study the relation of viral respiratory colonization with respiratory support2. To…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Respiratory viral colonization calculated as number of viruses per 7 patient
days and proportion of patients colonized with a virus
Secondary outcome
* Duration of hospitalization
* Days on respiratory support
* Quality of viral pathogens
* Number of infectious episodes and infection dynamics
Background summary
Viral infections are currently underdiagnosed in neonatal high care wards but
might lead to a substantial burden of disease. Limited data are available
about the prevalence of viral infections on the high care neonatology wards
since routine testing is not performed. Surveillance studies of outbreaks of
nosocomial infections in NICU patients report an incidence of 5-6% of all
infections (1). This was confirmed by Ronchi et al. who report that 6% of all
NICU sepsis evaluations had a respiratory virus detected when evaluated for
bacterial sepsis (2). In a study looking for rhinovirus (HRV) infection in
neonates, patients carrying HRV were longer hospitalized and had greater use
and duration of supplemental oxygen, a prolonged ventilator support and twice
the rate of bronchopulmonary dysplasia (3).
Many neonates suspected for bacterial infection have negative blood cultures.
In addition, inflammatory markers often fail to distinguish between a bacterial
or viral infection (4).
New molecular technologies however could easily facilitate the detection of
viruses and could increase our understanding of clinical signs of infection in
preterm born neonates without having a bacterial infection.
We know that many neonates do not show obvious signs of infection when carrying
a respiratory virus. Nonetheless, this might lead to longer respiratory support
without even noticing its relation. In theory, preventive measures could lead
to reduced respiratory support and hospitalization in premature neonates with
and without having signs of infection.
A study performed at the neonatal intensive care supports this theory. They
showed that nosocomial respiratory viruses were frequent, despite the absence
of clinical indicators of illness (5). Also, there was a significant relation
with length of hospital admittance and the diagnosis BPD (5).
It was shown that most patients with enteroviral and RSV infections were
probably infected by the horizontal route (6).,Creating greater awareness of
infection risk and hygiene measure may lead to a significant reduction in their
occurrence.
Currently we do not know the incidence of viral colonization of patients on a
high care ward and its influence on respiratory support and signs of clinical
infection. Therefore, this study will look into detail to viral infections
among vulnerable neonates and aims to reduce the possible morbidity related to
viral infection at this age.
References:
1. Change in epidemiology of health care *associated infections in a neonatal
intensive care unit. Nambiar S, Singh N. et al. The pediatric Infectiouse
diseases journal 2002: 21:839-842
2. Viral Respiratory Tract Infections in the Neonatal Intensive Care Unit: The
VIRIoN-I study. Andrea Ronchi, MD, Ian C. Michelow, MD et al. The journal of
Pediatrics. 2014;165:690-6)
3. Nosocomial Rhinovirus Infection in Preterm Infants. Manuel Steiner, MD;
Robert Strassl, MD; Julia Straub, MD; et al. The Journal of Pediatric
Infectious Disease Journal. 2012;31(12):1302-4.
4. Detection of Respiratory Viral Infections in Neonates Treated for Suspicion
of Nosocomial Bacterial Sepsis. Andr Kidszun, MD; Anne Hans-mann; Julia Winter,
MD; et al. The pediatric Infectious Disease Journal. 2014;33(1):102-104.
5. Incidence and implications of unrecognized viral respiratory tract
infections in premature infants during their birth hospitalization: a
prospective surveillance study in two neonatal intensive care units. Nicholas
J. Bennett, MD, PhD, Christy M Tabarani, MD et al. The journal of paediatrics
2012; 161 (5):814-818
6. Clinical and Epidemiologic Characteristics of Viral Infections in a neonatal
intensive care unit during a 12 year period. Verboon-Maciolek, MD, Krediet, MD
et al. The Pediatric Infectious Disease Journal 2005;24:901-904
Study objective
Primary Objective
To determine the prevalence of respiratory viral colonization/infection in
pre-term born neonates during hospitalisation.
Secondary Objectives
1. To study the relation of viral respiratory colonization with respiratory
support
2. To determine the presence of viral respiratory and gastro-intestinal
infections among preterm neonates who are suspected for late-onset sepsis.
3. To compare the length of stay of patients with- and without viral
colonization
Study design
This study is an investigator initiated prospective cohort study. Infants will
be recruited in Dutch secondary teaching hospitals with a high care neonatal
ward within the Rotterdam area, starting in the St. Franciscus Hospital
Rotterdam.
Study burden and risks
NP washes are a routine procedure done at the neonatology department,
collection of feces is not invasive. We do not foresee risks.
Kleiweg 500 Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500 Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
All premature neonates (AD < 37 weeks) admitted at the high/medium care ward > 1 week old.
Exclusion criteria
There are no specific exclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54455.101.15 |