Preterm InfanteKMCNCT03555981
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
A study testing Early Kangaroo Mother Care in people with Preterm Infant and Hypothermia, Newborn, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Preterm Infant, Hypothermia, Newborn, Death
- What is being tested?
- Early Kangaroo Mother Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteThe Gambia
- Study dates
- 20 May 2018to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- New admission to study site during study period
- Admission weight <2000g
- Age 1 - 24h at start of screening
- Alive at enrolment
- Availability of study bed
- Written informed consent from parent or caregiver
- Parent or caregiver available and willing to provide intervention, if necessary
Who cannot join
- Congenital malformation incompatible with life or needing immediate surgical correction
- Severe jaundice needing immediate management
- Seizures
- Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
- Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
- Completed triplet admission
- Mother and/or neonate enrolled in another research study at time of hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia
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.
Read the detailed description
This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates <2000g and aged <24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at <24h of admission) or standard care with continuous KMC at >24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.
Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.
- Being tested
- Early Kangaroo Mother Care, Standard care
- Medical subject headings
- Premature Birth, Hypothermia, Death, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Kangaroo Mother CareOther
Also called Early skin-to-skin contact, Early kangaroo method
Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
Standard careOther
Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care
| Study group | Role | What they receive |
|---|---|---|
| Early KMC | Experimental | Continuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home Receives: Other: Early Kangaroo Mother Care |
| Standard care | Active comparator | Standard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
All neonatal deaths within 28 postnatal days
Measured: 28 days
Secondary outcomes (8)
Time to Death
Time from start of intervention/control procedures to death
Measured: 28 days of age
Cardio-respiratory Stability
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.
Measured: At 24 hours after start of intervention/control procedures
Number and Proportion of Participants With Hypothermia
Number and proportion of participants with hypothermia (Temperature <36.5 degrees Celsius)
Measured: At 24 hours after start of intervention/control procedures
Weight Gain
Average daily weight gain compared to admission weight
Measured: At 28 days of age
Exclusive Breastfeeding
Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)
Measured: At time of hospital discharge, within study period, on average 2 weeks of age
Suspected Infection Between 3d to 28d of Age
Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up
Measured: Within 28 days of age
Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae
Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae
Measured: At day 28 of age
Duration of Hospital Admission
Mean length of admission (first admission only if re-admitted)
Measured: Within 28 days of age or at latest follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start20 May 2018
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Why it stopped: In response to COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomised controlled superiority trial
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council Unit, The Gambia
- Responsible party
- Sponsor
- Investigators
- Helen C Brotherton, MBChB, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555981
- Sponsor's protocol ID
- 14545
- Acronym
- eKMC
- Status last verified
- Jul 2019
- First submitted
- 8 May 2018
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, Darboe S, Jallow M, Ceesay B, Samateh AL, Tann CJ, Cousens S, Roca A, Lawn JE. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021 Aug 6;39:101050. doi: 10.1016/j.eclinm.2021.101050. eCollection 2021 Sep.
PubMed 34401686Brotherton H, Gai A, Tann CJ, Samateh AL, Seale AC, Zaman SMA, Cousens S, Roca A, Lawn JE. 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). Trials. 2020 Mar 6;21(1):247. doi: 10.1186/s13063-020-4149-y.
PubMed 32143737
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia
- ClinicalTrials.gov ID
- NCT03555981
- Acronym / sponsor ID
- eKMC / 14545
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In response to COVID pandemic
- Enrolment
- 279 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Trust, Medical Research Council Unit, The Gambia
- Study start
- 20 May 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 16 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates <2000g and aged <24h at time of screening who receive either early continuous kangaroo mother care (KMC) (started at <24h of admission) or standard care with continuous KMC at >24h of admission and when stable. The intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm. Intention to treat analysis will be used. Duration of time spent in KMC will be documented and compared between arms. All other hospital management will be provided as per a Standardised Preterm Management Protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms.
Underlying protective mechanisms for early KMC will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individually randomised controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Early KMC | Experimental | Other: Early Kangaroo Mother CareContinuous kangaroo mother care started within 24h of hospital admission, aiming for minimum 18h/day and until hospital discharge with encouragement of KMC at home |
| Standard care | Active comparator | Other: Standard careStandard care under radiant heater or incubator until clinical stability criteria are met then intermittent or continuous Kangaroo mother care started at >24h of hospital admission until hospital discharge with encouragement of KMC at home |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- New admission to study site during study period
- Admission weight <2000g
- Age 1 - 24h at start of screening
- Alive at enrolment
- Availability of study bed
Key exclusion criteria (7 listed)
- Congenital malformation incompatible with life or needing immediate surgical correction
- Severe jaundice needing immediate management
- Seizures
- Clinically stable as assessed over pre-defined period of cardio-respiratory monitoring
- Severely unstable as assessed over pre-defined period of cardio-respiratory monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Kangaroo Mother CareAlso: Early skin-to-skin contact, Early kangaroo methodContinuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission | Other | Early KMC |
| Standard careIncubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care | Other | Standard care |
Primary outcome
All-cause Mortality
Time frame: 28 days
All neonatal deaths within 28 postnatal days
8 secondary outcomes
Time to Death
Time frame: 28 days of age
Cardio-respiratory Stability
Time frame: At 24 hours after start of intervention/control procedures
Number and Proportion of Participants With Hypothermia
Time frame: At 24 hours after start of intervention/control procedures
Weight Gain
Time frame: At 28 days of age
Exclusive Breastfeeding
Time frame: At time of hospital discharge, within study period, on average 2 weeks of age
Suspected Infection Between 3d to 28d of Age
Time frame: Within 28 days of age
Neonatal Intestinal Carriage of Extended Spectrum Beta-Lactamase-producing Klebsiella Pneumoniae
Time frame: At day 28 of age
Duration of Hospital Admission
Time frame: Within 28 days of age or at latest follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34401686Brotherton H, Gai A, Kebbeh B, Njie Y, Walker G, Muhammad AK, Darboe S, Jallow M, Ceesay B, Samateh AL, Tann CJ, Cousens S, Roca A, Lawn JE. Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial. EClinicalMedicine. 2021 Aug 6;39:101050. doi: 10.1016/j.eclinm.2021.101050. eCollection 2021 Sep.
- Derived from this study: PubMed 32143737Brotherton H, Gai A, Tann CJ, Samateh AL, Seale AC, Zaman SMA, Cousens S, Roca A, Lawn JE. 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). Trials. 2020 Mar 6;21(1):247. doi: 10.1186/s13063-020-4149-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen C Brotherton, MBChB principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Kangaroo Mother Care in people with Preterm Infant and Hypothermia, Newborn, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555981, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.