Table 2 Primary and secondary outcome measures
Outcome | Definition |
|---|---|
Primary outcome | |
All-cause neonatal mortality | Death from any cause in the first 28 days of life |
Secondary outcomes | |
Incidence of omphalitis | A) None (no redness or swelling); |
B) Mild (inflammation limited to the cord stump); | |
C) Moderate (inflammation extending to the skin at the base of the cord stump less than 2 cm); or | |
D) Severe (inflammation extending more than 2 cm from the cord stump) | |
Incidence of severe infection | A) Convulsions; or |
B) Fast breathing (60 breaths per minute or more); or | |
C) Severe chest indrawing; or | |
D) Movement only when stimulated or no movement at all; or | |
E) Not feeding at all for at least 12 hours | |
Cases of hypothermia and hyperthermia identified | Defined using ThermoSpot: |
A) Moderate hypothermia: pale green and red face (35°C to 36°C) | |
B) Severe hypothermia: black face (<35°C) | |
C) Hyperthermia: blue face (>39°C) | |
Number of LBW newborns identified | <2500 grams at first weighing |
Health facility use | Health centre visits to |
A) Dispensary | |
B) Basic Health Unit (BHU) | |
C) Rural Health Centre (RHC) | |
D) Tehsil Head Quarter (THQ) | |
E) District Head Quarter (DHQ) | |
F) Private clinic | |
G) Private Hospital | |
Neurodevelopment at 12 months of age | Defined by the neurodevelopment score assigned at 12 months of age as measured by the standardized Bayley Scales of Infant Development III assessment tool |