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Table 3 Primary and secondary outcome measures

From: Effect of provision of an integrated neonatal survival kit and early cognitive stimulation package by community health workers on developmental outcomes of infants in Kwale County, Kenya: study protocol for a cluster randomized trial

Outcome Definition
Primary Outcome
Neurodevelopment at 12 months of age Defined by the development score assigned at 12 months of age as measured by the standardized Protocol for Child Monitoring – Infant and Toddler Version
Secondary Outcomes
All-cause neonatal mortality Death from any cause in the first 28 days of life
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 h
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 g at first weighing
Health facility use Health centre visits to
A) Dispensary
B) Health Centre
C) Subcounty Hospital
D) County Hospital
E) Coast General Hospital
F) Private clinic/hospital
Knowledge, attitudes, practices and willingness to pay for the newborn toolkit Defined by self-reported data on:
A) Use of each kit component
B) Purpose of each kit component
C) Perceptions on ease of use
D) Perceptions on safety and effectiveness of kit
E) Willingness to Pay for the kit