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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



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