NCT02811432: OMWaNA

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

Completed NA Results posted Last updated 8 January 2026

What this trial tests

NA trial testing Kangaroo mother care in Kangaroo Mother Care in 2,221 participants. Completed in 30 September 2022.

Timeline

13 October 2019

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,221
Start date	13 October 2019
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	4 locations across Uganda

Drugs / interventions tested

• Kangaroo mother care
• Standard care — full drug profile →

Conditions studied

• Kangaroo Mother Care — all drugs for Kangaroo Mother Care →
• Preterm Infant — all drugs for Preterm Infant →
• Death; Neonatal — all drugs for Death; Neonatal →
• Hypothermia, Newborn — all drugs for Hypothermia, Newborn →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 1 Hour to 48 Hours, any sex, with Kangaroo Mother Care or Preterm Infant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mortality Within 7 Days Primary · 7 days

early neonatal mortality at 7 days

Group	Value	95% CI
Intervention	81
Control	83

Prevalence of Hypothermia at 24 Hours Post-randomisation Secondary · 24 hours

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

Group	Value	95% CI
Intervention	448
Control	585

Time From Intervention/Control Procedures Starting to Clinical Stabilisation Secondary · 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.

Group	Value	95% CI
Intervention	5.1	4.1 – 6.7
Control	4.9	3.8 – 6.5

Time From Starting Intervention/Control Procedures to Death Secondary · 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.

Group	Value	95% CI
Intervention	5.0	2.5 – 10.7
Control	5.9	2.8 – 13.9

Mean Duration of Hospital Stay in Days Secondary · 30 days

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

Group	Value	95% CI
Intervention	7.3	± 0.15
Control	6.1	± 0.14

Proportion of Neonates Exclusively Breastmilk Feeding at Discharge Secondary · 30 days

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

Group	Value	95% CI
Intervention	959
Control	978

Mortality Within 28 Days Secondary · 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.

Group	Value	95% CI
Intervention	119
Control	134

Frequency of Readmission Secondary · 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.

Group	Value	95% CI
Intervention	0.02	± 0.01
Control	0.04	± 0.01

Daily Weight Gain at 28 Days Secondary · 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.

Group	Value	95% CI
Intervention	7.8	± 0.3
Control	7.1	± 0.3

Infant-caregiver Attachment at 28 Days Secondary · 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.

Group	Value	95% CI
Intervention	85.4	± 0.28
Control	85.0	± 0.28

Women's Well-being at 28 Days Secondary · 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.

Group	Value	95% CI
Intervention	0.69	± 0.01
Control	0.68	± 0.01

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days of age. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 124/1051 (12%)

Deaths: 119/1051

Control

Serious: 125/1049 (12%)

Deaths: 134/1049

Serious adverse events (9 terms)

Reaction	System	Intervention	Control
SAEs and other adverse events	Respiratory, thoracic and mediastinal disorders	—	—
neonatal infections	Infections and infestations	—	—
SAEs and other adverse events	Gastrointestinal disorders	—	—
SAEs and other adverse events	Blood and lymphatic system disorders	—	—
Neurological disorders	Nervous system disorders	—	—
Neonatal jaundice	Hepatobiliary disorders	—	—
Hyperthermia	General disorders	—	—
SAEs and other adverse events	Cardiac disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention	Control
Neonatal jaundice	Hepatobiliary disorders	—	—

Most-reported serious reactions: SAEs and other adverse events, neonatal infections, SAEs and other adverse events, SAEs and other adverse events, Neurological disorders, Neonatal jaundice, Hyperthermia, SAEs and other adverse events.

Data from ClinicalTrials.gov NCT02811432 adverse events section.

Sponsor's own description

We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care. The primary aim is to examine the impact of KMC initiated before stabilisation on mortality within 7 days relative to standard care amongst neonates ≤2000g at four hospitals in Uganda. We hypothesise that neonates in the arm allocated to receive KMC before stabilisation will have a 25% overall reduction in mortality within 7 days compared to neonates allocated to receive standard care.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial.
   Brotherton H, Gai A, Kebbeh B, Njie Y, et al · · 2021 · cited 27× · PMID 34401686 · DOI 10.1016/j.eclinm.2021.101050
2. Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
   Tumukunde V, Medvedev MM, Tann CJ, Mambule I, et al · · 2024 · cited 23× · PMID 38754454 · DOI 10.1016/s0140-6736(24)00064-3
3. Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda.
   Medvedev MM, Tumukunde V, Mambule I, Tann CJ, et al · · 2020 · cited 22× · PMID 32005286 · DOI 10.1186/s13063-019-4044-6
4. Process and costs for readiness to safely implement immediate kangaroo mother care: a mixed methods evaluation from the OMWaNA trial at five hospitals in Uganda.
   Medvedev MM, Tumukunde V, Kirabo-Nagemi C, Greco G, et al · · 2023 · cited 10× · PMID 37301974 · DOI 10.1186/s12913-023-09624-z