Transcript FAQs at the INIS Meeting

INIS in practice
Recruitment
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Ideas for boosting recruitment in your unit
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Raising awareness of INIS on your unit
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Dealing with staff antagonism
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Coordinating Centre involvement
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Marketing INIS – what can we do better
Identifying eligible
babies
The eligibility criteria
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Proven or suspected serious infection
and
- less than 1500 g birth weight
or
- has evidence of infection in blood or CSF
or a normally sterile site
or
- on respiratory support by ETT
and
Receiving antibiotics
Exclusions: already had IVIG or IVIG considered
necessary or contraindicated
Identifying eligible
babies
• Difficulties with eligibility criteria?
• How do you identify eligible babies
• How do you ensure that eligible babies
are not missed?
Identifying eligible
babies
• known positive blood culture
• suspected infection after clinical chorioamnionitis
• suspected pneumonia
• Coagulase Negative Staphylococcus/ Staph epidermidis grown
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in blood cultures and not thought to be a contaminant
Infants with a proven culture who are not severely ill, not
ventilated and already recovering, and still receiving antibiotics.
an infant who makes a poor response to surfactant
any infant for whom you think there is sufficient clinical
concern that a course of antibiotics will be continued for 5 days
or more regardless of the culture results
any infant who reaches 5 days of antibiotics, has suspected or
proven clinical sepsis and has not yet been considered for INIS
Informed consent
• Who can obtain consent?
• Difficulties of the consent process
• Differences between units – what
influences consent rates?
• Tips for obtaining consent
FAQs
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Are babies with fungal or viral infections eligible for
INIS?
YES! Babies with bacterial or viral or fungal sepsis,
commenced on antibiotics or antifungals for a
suspected or proven infection should be considered
for the INIS trial.
We are including bacterial, viral and fungal
infections, and therefore being on antifungals or
antivirals is taken as being eligible, in terms of the
eligibility criteria.
FAQs
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If a baby is mistakenly randomised to INIS is it still necessary to complete
entry and discharge forms and arrange follow-up? Is the baby still
considered to be a part of the trial?
Yes. A baby is considered randomised to INIS once consent is obtained
and the pharmacist starts preparing the 1st syringe, regardless of
whether any drug is infused. All such babies should have complete data
collection including a 2 year follow-up because analysing study subjects
in the groups to which they were initially randomised (intention to treat
analysis) is the best way to minimise bias in the study results.
This includes if:
- Following receipt of informed consent and preparation of the 1st
syringe, you discover that the baby actually does not meet the eligibility
criteria.
- Withdrawal of consent by parents at any time after the INIS treatment
has been prepared
- Incomplete administration of INIS drug course
FAQs
• What is considered a normally sterile
site?
FAQs
• Will intravenous immunoglobulin (IVIG)
interfere with routine infant vaccinations?
FAQs
• Until what age are babies eligible for
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INIS?
Babies remain eligible at any age whilst
they are resident on the neonatal unit.
Once they have been discharged they are
eligible up until their EDD (estimated date
of delivery) plus 28 days.
FAQs
• Are babies who are starting to recover
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from their infection still eligible?
Yes, as long as they still meet the
eligibility criteria. IVIG has the potential
to limit cytokine-mediated white matter
damage and hasten remyelination, so it
may be beneficial even after the initial
injury.
FAQs
Others……………….