Zinc in addition to antibiotics for treating newborn babies with sepsis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2913

Inclusion Criteria

We have adapted the inclusion criteria from the WHO IMCI and IMNCI to identify very sick infants aged 3 days to 59 days with clinical severe infection

1)Low body temperature less than 35.5 deg Celsius AND, OR

2)Movement only when stimulated AND, OR

3)Stopped feeding well AND, OR

4)Severe chest indrawing AND, OR

5) Axillary temperature more than or equal to 38.0 deg Celsius and Infant should have been well at some point from birth till the current episode of illness

Exclusion Criteria

1) Surgical or life-threatening malformation or condition that will interfere with administration of oral or oro-gastric (OG) or naso-gastric (NG) intervention

2) Infants requiring surgical intervention or admission outside of pediatric ward for management

3) Documented evidence of having received more than 1mg of elemental zinc per day in the last 48 hours

4) Documented evidence of having received injectable antibiotics for 48 hours or more for this illness episode

5) Weight at presentation less than 1500 gm

6) infants requiring exchange transfusion

Those infants who fulfill the criteria of clinical severe infection and do not have any exclusion criteria but are very sick and not allowed oral or nasogastric intervention will not be enrolled immediately but will be observed during a stabilization period when they will be observed by the study nurse every 8th hourly for a maximum period of 24 hours of

stabilization. Infants who have been stabilized and allowed orally, anytime within the 24 hour stabilization period and who after stabilization continue to have at least one sign of clinical severe infection, no exclusion criteria and whose parents or guardians have given written informed consent for participation will now fulfill the eligibility criteria