1. INIS in practice

2. 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

3. 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 siteor - on respiratory support by ETT and Receiving antibiotics Exclusions: already had IVIG or IVIG considered necessary or contraindicated

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

5. 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

6. Informed consent Who can obtain consent? Difficulties of the consent process Differences between units – what influences consent rates? Tips for obtaining consent

7. 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.

8. 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

9. FAQs What is considered a normally sterile site?

10. FAQs Will intravenous immunoglobulin (IVIG) interfere with routine infant vaccinations?

11. 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.

12. 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.

13. FAQs Others……………….