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Table 2 Primary and secondary outcome measures

From: The community-based delivery of an innovative neonatal kit to save newborn lives in rural Pakistan: design of a cluster randomized trial

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