Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Mortality Within 7 Days	7 days	early neonatal mortality at 7 days
Secondary	Prevalence of Hypothermia at 24 Hours Post-randomisation	24 hours	Prevalence of hypothermia at 24 hours post-randomisation using axillary temperature was assessed using a digital thermometer.
Secondary	Time From Intervention/Control Procedures Starting to Clinical Stabilisation	30 days	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.
Secondary	Time From Starting Intervention/Control Procedures to Death	30 days	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.
Secondary	Mean Duration of Hospital Stay in Days	30 days	The date and time of hospital admission and discharge were documented prospectively for the first admission episode.
Secondary	Proportion of Neonates Exclusively Breastmilk Feeding at Discharge	30 days	Proportion of neonates who were exclusively breastmilk feeding at discharge, from the breast or by other means
Secondary	Mortality Within 28 Days	28 days	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.
Secondary	Frequency of Readmission	30 days	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.
Secondary	Daily Weight Gain at 28 Days	28 days	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.
Secondary	Infant-caregiver Attachment at 28 Days	28 days	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.
Secondary	Women's Well-being at 28 Days	28 days	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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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