Trial Outcomes & Findings for Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa (NCT NCT02811432)

Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa

early neonatal mortality at 7 days

Prevalence of hypothermia at 24 hours post-randomisation using axillary temperature was assessed using a digital thermometer.

Time-to-stabilization was defined as the first time at which a neonate had met all of the following criteria for a continuous period of at least 24 hours: breathing spontaneously with SpO2 \>90% in room air; no need for supplemental oxygen or CPAP; respiratory rate 40-59 breaths per minute; no apneic episodes; heart rate 80-179 beats per minute; axillary temperature 36.0-37.4 °C; and no need for intravenous fluids.

The date and time of death were prospectively recorded from the death certificate for in-hospital deaths. For deaths occurring after discharge, the date was recorded based on parent/caregiver verbal report. Median and IQR of time-to-event calculated as the 50th and 25th to 75th percentile of the distribution of event times among those who experienced the event.

The date and time of hospital admission and discharge were documented prospectively for the first admission episode.

Proportion of neonates who were exclusively breastmilk feeding at discharge, from the breast or by other means

All-cause mortality within 28 days. Vital status was documented at the 28-30-day follow-up visit. If participants did not attend, a telephone call was made the same day to ascertain outcome.

Episodes in which a neonate was readmitted to the index hospital were prospectively recorded. Episodes in which a neonate was readmitted to a different hospital were recorded based on parent/caregiver verbal report.

Mean daily weight gain was calculated as the difference between weight at enrollment and 28-30-day follow-up, as measured by the study scale.

The intention-to-treat analysis assessed the mean difference in Maternal Infant Responsiveness Instrument score between the two arms. Scores range from 0 to 110, with higher scores indicating greater attachment.

The intention-to-treat analysis assessed the mean difference in Women's Capabilities Index (WCI) score between the two arms. The WCI has a scale of 0 to 1, with higher scores indicating greater wellbeing. The analysis excluded duplicate entries for mothers of enrolled twins/triplets.