Remarks

• In making this recommendation, the Guideline Development Group emphasized the need to avoid harm, given the uncertainty of the evidence and the conflicting results of research studies, as well as implementation costs.
• The proposed infant mortality rate of greater than 50 per 1000 live births was calculated based on several assumptions:
• 50% of the total infant mortality rate are neonatal deaths;
• 50% of neonatal mortality occurs within 24 hours after birth;
• the post-neonatal mortality rate up to 6 months of age makes up two thirds (2/3) of the total infant mortality rate, and the mortality rate between 6 and 12 months of age makes up the remaining one third (1/3);
• the rate of 30 deaths per 1000 used in the studies accounts for deaths between enrolment in the study up to 6 months of age;
• dosing/enrolment almost always occurred within the first 24 hours after birth.