NCT03555981: eKMC

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

Terminated NA Results posted Last updated 16 April 2026

What this trial tests

NA trial testing Early Kangaroo Mother Care in Preterm Infant in 279 participants. Terminated before completion.

Timeline

20 May 2018

Primary endpoint
20 April 2020

20 April 2020

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	279
Start date	20 May 2018
Primary completion	20 April 2020
Estimated completion	20 April 2020
Sites	1 location across The Gambia

Drugs / interventions tested

• Early Kangaroo Mother Care
• Standard care — full drug profile →

Conditions studied

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

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 1 Hour to 24 Hours, any sex, with Preterm Infant or Hypothermia, Newborn. 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.

All-cause Mortality Primary · 28 days

All neonatal deaths within 28 postnatal days

Group	Value	95% CI
Early KMC	29
Standard Care	34

Time to Death Secondary · 28 days of age

Time from start of intervention/control procedures to death

Group	Value	95% CI
Early KMC	90.0	65 – 172
Standard Care	98.5	29 – 132

Cardio-respiratory Stability Secondary · At 24 hours after start of intervention/control procedures

The 'Stability of Cardio-Respiratory in Preterm' infants is a scale to quantify the cardio-respiratory stability of preterm infants. It is composed of three parameters: Heart rate; Respiratory rate and breathing pattern and oxygen saturation (including whether is in oxygen). Scores between 0 and 2 are allocated for each parameter, with minimum total score 0 and maximum total score 6. The highest score (6) represents a better outcome, with all parameters within normal range whilst not receiving oxygen.

Group	Value	95% CI
Early KMC	5	4 – 5
Standard Care	5	4 – 6

Number and Proportion of Participants With Hypothermia Secondary · At 24 hours after start of intervention/control procedures

Number and proportion of participants with hypothermia (Temperature \<36.5 degrees Celsius)

Group	Value	95% CI
Early KMC	51
Standard Care	55

Weight Gain Secondary · At 28 days of age

Average daily weight gain compared to admission weight

Group	Value	95% CI
Early KMC	10.3	± 10.1
Standard Care	12.5	± 12.1

Exclusive Breastfeeding Secondary · At time of hospital discharge, within study period, on average 2 weeks of age

Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)

Group	Value	95% CI
Early KMC	107
Standard Care	105

Suspected Infection Between 3d to 28d of Age Secondary · Within 28 days of age

Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up

Group	Value	95% CI
Early KMC	28
Standard Care	21

Duration of Hospital Admission Secondary · Within 28 days of age or at latest follow-up

Mean length of admission (first admission only if re-admitted)

Group	Value	95% CI
Early KMC	16.6	± 11.1
Standard Care	16.3	± 10.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 postnatal days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Early KMC

Serious: 30/138 (22%)

Deaths: 29/138

Standard Care

Serious: 28/141 (20%)

Deaths: 34/141

Serious adverse events (4 terms)

Reaction	System	Early KMC	Standard Care
Life threatening event	General disorders	—	—
Risk of disability	Nervous system disorders	—	—
Prolonged hospitalisation	General disorders	—	—
Hospital re-admission	General disorders	—	—

Most-reported serious reactions: Life threatening event, Risk of disability, Prolonged hospitalisation, Hospital re-admission.

Data from ClinicalTrials.gov NCT03555981 adverse events section.

Sponsor's own description

The mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

Publications & conference data

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

1. Development and validation of a simplified score to predict neonatal mortality risk among neonates weighing 2000 g or less (NMR-2000): an analysis using data from the UK and The Gambia.
   Medvedev MM, Brotherton H, Gai A, Tann C, et al · · 2020 · cited 31× · PMID 32119841 · DOI 10.1016/s2352-4642(20)30021-3
2. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates &lt;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
3. Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).
   Brotherton H, Gai A, Tann CJ, Samateh AL, et al · · 2020 · cited 8× · PMID 32143737 · DOI 10.1186/s13063-020-4149-y