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Table 1 Primary and secondary outcomes

From: Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8 kg: study protocol for a randomized controlled trial

Primary outcome
 The proportion of:
   Neonatal deaths between enrollment and 72 h of age measured through vital status records every 12 h during hospital stay
   Neonatal deaths between enrollment and 28 days of age measured through vital status records every 12 h during hospital stay and at a home visit on day 29 of age.
Secondary outcomes
 The proportion of:
   Infants receiving exclusive breastfeeding (or exclusive breast-milk feeding) at the end of the neonatal period measured by 24-h feeding recall at a home visit on day 29 of age. (Exclusive breastfeeding is defined as an infant receiving only breast milk and no other liquid or solid, with the exception of vitamin or mineral supplements, medicines, or oral rehydration solution, if prescribed.)
   Infants with clinically suspected sepsis as per 12-hourly records during hospital stay.
   Infants with hypothermia defined as any axillary temperature of less than 36 °C from 2 h after randomization until discharge (or 28 days of age if not discharged before then).
   Infants with hypoglycemia defined as any blood glucose of less than 45 mg/dL (2.6 mmol/L) at mandatory measures at 6, 12, 18, and 24 h of age or at any other time.
   Time to being fully breastfed: age at which the baby could feed fully by suckling on the breast without requiring any feeding by cup or nasogastric tube as per 12-hourly records.
   Time to clinical stabilization: age at which the baby is considered to be clinically stable as per 12-hourly records and defined stability criteria.
   Maternal satisfaction with health care in the hospital as per interviews.
   Maternal depression defined as a score of 15 points or more in the Patient Health Questionnaire 9 (PHQ-9) administered to mothers at the day-29 home visit (Kroenke 2011).