An interventional study of Early Kangaroo Mother Care and Standard care in Preterm Infant, Hypothermia, Newborn and Death, sponsored by London School of Hygiene and Tropical Medicine. Terminated at 1 site in The Gambia. Open to participants aged 1 Hour to 24 Hours. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Treatment
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.
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 If participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start KMC when clinically stable, as per the control arm.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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 279 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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
Other: Early Kangaroo Mother Care
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
Other: Standard care
Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
Also known as: Early skin-to-skin contact, Early kangaroo method
Incubator or radiant heater care until stable, off oxygen and \>24h of admission, at which point will start intermittent or continuous kangaroo mother care
All-cause Mortality
All neonatal deaths within 28 postnatal days
Time frame: 28 days
Time to Death
Time from start of intervention/control procedures to death
Time frame: 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.
Time frame: 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)
Time frame: At 24 hours after start of intervention/control procedures
Weight Gain
Average daily weight gain compared to admission weight
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: At day 28 of age
Duration of Hospital Admission
Mean length of admission (first admission only if re-admitted)
Time frame: Within 28 days of age or at latest follow-up
Recruitment took place from 23rd May 2018 - 19th March 2020 at the neonatal unit of the only teaching hospital in The Gambia, providing WHO level 2+ newborn care.
| Milestone | Early KMC | Standard Care |
|---|---|---|
| Started | 138 | 141 |
| Completed | 138 | 139 |
| Not completed | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 |
All neonatal deaths within 28 postnatal days
| Participants | Early KMC | Standard Care |
|---|---|---|
| All-cause Mortality | 29 | 34 |
Time from start of intervention/control procedures to death
| hours | Early KMC | Standard Care |
|---|---|---|
| Time to Death | 90.0 (65 to 172) | 98.5 (29 to 132) |
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.
| units on a scale | Early KMC | Standard Care |
|---|---|---|
| Cardio-respiratory Stability | 5 (4 to 5) | 5 (4 to 6) |
Number and proportion of participants with hypothermia (Temperature \<36.5 degrees Celsius)
| Participants | Early KMC | Standard Care |
|---|---|---|
| Number and Proportion of Participants With Hypothermia | 51 | 55 |
Average daily weight gain compared to admission weight
| grams/day | Early KMC | Standard Care |
|---|---|---|
| Weight Gain | 10.3 ± 10.1 | 12.5 ± 12.1 |
Number of babies who are exclusively breastfed (defined as only receiving breast milk with no infant formula supplementation)
| Participants | Early KMC | Standard Care |
|---|---|---|
| Exclusive Breastfeeding | 107 | 105 |
Number and proportion of participants with suspected infection between 3d to 28d of age, or age at latest follow up
| Participants | Early KMC | Standard Care |
|---|---|---|
| Suspected Infection Between 3d to 28d of Age | 28 | 21 |
Number and proportion of participants with intestinal carriage of Extended Spectrum Beta-Lactamase-Klebsiella pneumoniae
Results for this outcome have not been posted.
Mean length of admission (first admission only if re-admitted)
| Days | Early KMC | Standard Care |
|---|---|---|
| Duration of Hospital Admission | 16.6 ± 11.1 | 16.3 ± 10.0 |
Collected over 28 postnatal days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early KMC | 29/138 (21%) | 30/138 (21.7%) | — |
| Standard Care | 34/141 (24.1%) | 28/141 (19.9%) | — |
| Event | Early KMC | Standard Care |
|---|---|---|
| Life threatening eventGeneral disorders | 13/138 | 11/141 |
| Prolonged hospitalisationGeneral disorders | 7/138 | 5/141 |
| Risk of disabilityNervous system disorders | 6/138 | 7/141 |
| Hospital re-admissionGeneral disorders | 4/138 | 5/141 |
| Age, Categorical(Participants) | Early KMC | Standard Care | Total |
|---|---|---|---|
| <=18 years | 138 | 141 | 279 |
| Between 18 and 65 years | NA | NA | NA |
| >=65 years | NA | NA | NA |
| Age, Continuous(hours) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Median | 2.3 (0.9 to 4.7) | 2.3 (0.7 to 5.0) | 2.3 (0.8 to 4.8) |
| Sex: Female, Male(Participants) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Female | 79 | 82 | 161 |
| Male | 59 | 59 | 118 |
| Race/Ethnicity, Customized(Participants) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Gambian | 138 | 141 | 279 |
| Region of Enrollment(participants) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Gambia | 138 | 141 | 279 |
| Admission weight(grams) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Median | 1459 (1204 to 1650) | 1436 (1180 to 1660) | 1450 (1180 to 1652) |
| Admission weight <1200g(Participants) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Count of participants | 34 | 39 | 73 |
| Gestational age(weeks) | Early KMC | Standard Care | Total |
|---|---|---|---|
| Median | 33 (31 to 34) | 32 (31 to 34) | 33 (31 to 34) |
3 further baseline measures are reported on the registry.
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London School of Hygiene and Tropical Medicine