Trial · NCT02811432

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

NCT02811432, Not applicable, Completed, London School of Hygiene and Tropical Medicine; results first posted 2026-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa. Trials, record NCT02811432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02811432

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
NCT number: NCT02811432
Status: Completed
Phases: Not applicable
Enrollment: 2,221 participants, actual
Lead sponsor: London School of Hygiene and Tropical Medicine
Conditions: Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
Interventions: Kangaroo mother care, Standard care
First posted: 2016-06-23
Last updated: 2026-01-08
Results first posted: 2026-01-08

Source ClinicalTrials.gov

Registered outcomes11

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

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.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mortality Within 7 Days	7 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Prevalence of Hypothermia at 24 Hours Post-randomisation	24 hours		participants	NUMBER
SECONDARY	Time From Intervention/Control Procedures Starting to Clinical Stabilisation	30 days		days	MEDIAN
SECONDARY	Time From Starting Intervention/Control Procedures to Death	30 days		hours	MEDIAN
SECONDARY	Mean Duration of Hospital Stay in Days	30 days	at the 28-30 day visit	days	MEAN
SECONDARY	Proportion of Neonates Exclusively Breastmilk Feeding at Discharge	30 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality Within 28 Days	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Frequency of Readmission	30 days	by 28-30 day visit	readmission count	MEAN
SECONDARY	Daily Weight Gain at 28 Days	28 days	by 28-30 day visit	g/kg/day	MEAN
SECONDARY	Infant-caregiver Attachment at 28 Days	28 days	day 28-30 visit	MIRA score	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mortality Within 7 Days	Intervention	81		Participants
Mortality Within 7 Days	Control	83		Participants
Prevalence of Hypothermia at 24 Hours Post-randomisation	Intervention	448		participants
Prevalence of Hypothermia at 24 Hours Post-randomisation	Control	585		participants
Time From Intervention/Control Procedures Starting to Clinical Stabilisation	Intervention	5.1	Inter-Quartile Range 4.1 to 6.7	days
Time From Intervention/Control Procedures Starting to Clinical Stabilisation	Control	4.9	Inter-Quartile Range 3.8 to 6.5	days
Time From Starting Intervention/Control Procedures to Death	Intervention	5.0	Inter-Quartile Range 2.5 to 10.7	hours
Time From Starting Intervention/Control Procedures to Death	Control	5.9	Inter-Quartile Range 2.8 to 13.9	hours
Mean Duration of Hospital Stay in Days	Intervention	7.3	Standard Error 0.15	days
Mean Duration of Hospital Stay in Days	Control	6.1	Standard Error 0.14	days

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention	1,110
Overall Study	STARTED	Control	1,111
Overall Study	COMPLETED	Intervention	1,083
Overall Study	COMPLETED	Control	1,102
Overall Study	NOT COMPLETED	Intervention	27
Overall Study	NOT COMPLETED	Control	9

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neonatal jaundice	Hepatobiliary disorders	Intervention	180	1,051	180
other	Neonatal jaundice	Hepatobiliary disorders	Control	90	1,049	90
serious	SAEs and other adverse events	Blood and lymphatic system disorders	Intervention	8	1,051	8
serious	SAEs and other adverse events	Blood and lymphatic system disorders	Control	10	1,049	10
serious	SAEs and other adverse events	Cardiac disorders	Intervention	0	1,051	0
serious	SAEs and other adverse events	Cardiac disorders	Control	1	1,049	1
serious	SAEs and other adverse events	Gastrointestinal disorders	Intervention	12	1,051	12
serious	SAEs and other adverse events	Gastrointestinal disorders	Control	7	1,049	7
serious	SAEs and other adverse events	Respiratory, thoracic and mediastinal disorders	Intervention	59	1,051	59
serious	SAEs and other adverse events	Respiratory, thoracic and mediastinal disorders	Control	63	1,049	63

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention	119	1,051
Total, all-cause mortality	Control	134	1,049
Total, other adverse events	Intervention	180	1,051
Total, other adverse events	Control	90	1,049
Total, serious adverse events	Intervention	124	1,051
Total, serious adverse events	Control	125	1,049

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32005286	BACKGROUND	PubMed
37301974	BACKGROUND	PubMed
38754454	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention vs Control: Proportion of Neonates Exclusively Breastmilk Feeding at Discharge	Trial comparisons
Intervention vs Control: Mortality Within 7 Days	Trial comparisons
Intervention vs Control: Prevalence of Hypothermia at 24 Hours Post-randomisation	Trial comparisons
Intervention vs Control: deaths from any cause	Trial comparisons
Intervention vs Control: Mortality Within 28 Days	Trial comparisons
Intervention vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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