INIS in practice

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INIS in practice
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Recruitment

• Ideas for boosting recruitment in your unit
• Raising awareness of INIS on your unit
• Dealing with staff antagonism
• Coordinating Centre involvement
• Marketing INIS what can we do better

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Identifying eligible babies

• The eligibility criteria
• 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

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Identifying eligible babies

• Difficulties with eligibility criteria?
• How do you identify eligible babies
• How do you ensure that eligible babies are not
  missed?

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Identifying eligible babies

• known positive blood culture
• suspected infection after clinical
  chorioamnionitis
• suspected pneumonia
• Coagulase Negative Staphylococcus/ Staph
  epidermidis grown 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

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Informed consent

• Who can obtain consent?
• Difficulties of the consent process
• Differences between units what influences
  consent rates?
• Tips for obtaining consent

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FAQs

• 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.

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FAQs

• 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

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FAQs

• What is considered a normally sterile site?

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FAQs

• Will intravenous immunoglobulin (IVIG) interfere
  with routine infant vaccinations?

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FAQs

• Until what age are babies eligible for 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.

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FAQs

• Are babies who are starting to recover 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.

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FAQs
Others.