In case of a non-significant treatment effect at 5%, the CI95% for the risk difference will include zero, and thus the 95% confidence interval for the number needed to treat will include infinity.
As self perceived need for care might be an important modifier for the risk of not being treated, we will include this parameter while searching for consequences of not being treated and for determinants of possible poor outcome after not being treated.
"Intention-to-treat" analysis will include all randomized participants.
The intention-to-treat population will include all randomised patients.
Analysis will be by intention to treat which will include withdrawals and losses to follow up.
Intention to treat analysis will include all randomized subjects, including drop-outs.
Intent-to-treat (ITT) will include any subject randomized according to their treatment assignment.
The intention-to-treat analyses will include all patients who were randomised at baseline regardless if they crossed over.
The intention-to-treat analysis will include participants who are protocol violators, but will not include participants who are post-randomisation exclusions.
The primary analysis for this intent-to-treat study will include all infants as randomized, regardless of adherence with the feeding protocol.
Data collected by the ED treating clinicians will include the predictor variables from the three CDRs (CATC H[ 11], PECARN [ 17], CHALICE [ 16]).
