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WHO Immediate KMC Study (iKMC)

A trial in five hospitals in Africa and India that tested starting skin-to-skin care right after birth for small babies, compared with starting it after they stabilized.

Also called iKMC · I-KMC

  • Study
  • In this atlas

Overview

Design
Multicentre, non-blinded (open-label), parallel-group randomized trial in five tertiary hospitals. Randomization was stratified by site and birth weight (1.0 to under 1.5 kg and 1.5 to under 1.8 kg) in variable blocks; twins were allocated to the same group. An independent team assessed outcomes. Mother-infant pairs were randomized: 3211 infants with 2944 mothers. Screening ran from 30 November 2017 to 20 January 2020.
Phase
Not applicable
Enrolled
  • 3,211 infants (randomized count) (Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight, retrieved )
  • 2,944 mothers (randomized count) (Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight, retrieved )
Sponsor
Funder
Registry
  • ANZCTR ACTRN12618001880235
  • CTRI CTRI/2018/08/015369
Started
(Effect of immediate Kangaroo Mother Care on neonatal mortality for mothers and babies, retrieved )
Primary completion
Not reported
Completion
Not reported
Countries
Ghana, India, Malawi, Nigeria, Tanzania (Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight, retrieved )
Care setting
Five tertiary-level hospitals. The intervention arm used a Mother-NICU, a newborn intensive care unit with beds for mothers. (Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight, retrieved )
Registry status

The registries disagree. Each status is shown as its record gives it.

  • “Stopped early” (Australian New Zealand Clinical Trials Registry, retrieved )
  • “Completed” (Clinical Trials Registry - India, read through the WHO ICTRP mirror, retrieved )
Stopped early
Enrollment stopped early, date not reported. After the second interim analysis, the data and safety monitoring board recommended stopping because of reduced mortality with immediate KMC. The CTRI record, seen through the WHO ICTRP mirror, gives the status as completed. (Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight, retrieved )

Technical summary

Multicentre, open-label randomized trial (ACTRN12618001880235; CTRI/2018/08/015369). 3211 infants and their 2944 mothers were randomized, against a registry target of 4200 infants. Birth weight 1.0 to under 1.8 kg. Primary outcomes: death to 28 days and to 72 hours. Enrolment stopped early on data and safety monitoring board advice. Primary sponsor: WHO. Funder: the Bill & Melinda Gates Foundation, per the abstract and both registries; PubMed's grant field separately lists the World Health Organization with grant ID "001".

Arms

  • Immediate KMC (intervention)

    Intervention Immediate kangaroo mother care

    Continuous skin-to-skin contact with the mother, or a female surrogate, started as soon as possible after birth in a Mother-NICU and continued in the KMC ward. ANZCTR gives an aim of at least 20 hours a day. Median time to first skin-to-skin contact was 1.3 hours, and the median daily duration in the NICU was 16.9 hours.

  • Conventional care, then KMC after stabilization (control)

    Intervention None named

    Care in an incubator or radiant warmer in the NICU, without the mother, until the infant stabilized. Brief KMC sessions were allowed once the infant was recovering and at least 24 hours old. Continuous KMC followed in the KMC ward after stabilization. Median time to first skin-to-skin contact was 53.6 hours, and the median daily duration in the NICU was 1.5 hours.

Findings

Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero, and findings from different contexts are not combined.

In plain words

In the iKMC trial, babies weighing 1.0 to under 1.8 kg at birth who started continuous skin-to-skin care with their mother within hours of birth were less likely to die in their first 28 days than babies who started it only after they were stable. 191 of 1596 babies died in the immediate group and 249 of 1587 in the control group (adjusted risk ratio 0.75, 95% CI 0.64 to 0.89).

Applies to Newborn
  • Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
  • Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
  • Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
  • Neonatal period
  • Gestational age Any, not restricted
  • Postnatal age 0 days to 0 days
Follow-up From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.

Infant death, enrolment to 28 days Primary endpoint

  1. 191 of 1,596 infants in the Immediate KMC (intervention) arm

    Measure
    Infants who died (count)
    Value
    191 infants
    Reported as
    191/1596 (12.0%)
    Interval
    Not applicable
    Denominator
    n = 1,596 (As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1609 infants were assigned to this arm.)
    Time window
    Enrolment to 28 days of age

  2. 249 of 1,587 infants in the Conventional care, then KMC after stabilization (control) arm

    Measure
    Infants who died (count)
    Value
    249 infants
    Reported as
    249/1587 (15.7%)
    Interval
    Not applicable
    Denominator
    n = 1,587 (As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1602 infants were assigned to this arm.)
    Time window
    Enrolment to 28 days of age

  3. Immediate KMC (intervention) compared with Conventional care, then KMC after stabilization (control)

    Measure
    Adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)
    Value
    0.75 ratio
    Reported as
    aRR 0.75 (0.64 to 0.89), P=0.001
    Interval
    0.64 to 0.89 (95% confidence interval)
    Denominator
    Not applicable (basis: Comparison of the two per-arm rows above)
    Time window
    Enrolment to 28 days of age

Caveats

  • Limitations. One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3). The per-arm denominators (1596 and 1587) are smaller than the numbers randomized (1609 and 1602). They come from the author manuscript's Table 3 only, its text does not state their basis, and they were not checked against the version of record.

Sources and citations (4)

  1. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Abstract, RESULTS, sentence 3: "relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001"
    How it applies
    Abstract of the primary report, for the same infants and time window as this context.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    5dde5eaa4d684f398f7f3cfab05816eb73207b8adbaac5c4163e7e480567ecf6
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  2. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, row "Death between enrolment and 28 days of age": "191/1596 (12.0%)" and "249/1587 (15.7%)"
    How it applies
    Author accepted manuscript (CC BY 4.0); not checked against the version of record.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  3. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, column header: "Adjusted RR (95%CI)"
    How it applies
    The ratios are adjusted, not crude; see the Table 3 footnote.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  4. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Discussion, para 5: "20% of infants 1.0 to <1.8 kg born in study hospitals were not enrolled because mother or newborn was too sick"
    How it applies
    Limits who the result describes.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

In plain words

In the first 72 hours, 74 of 1606 babies died with immediate skin-to-skin care and 92 of 1599 with the control approach (adjusted risk ratio 0.77, 95% CI 0.58 to 1.04). The interval includes no difference, so the trial did not show a clear effect in this window.

Applies to Newborn
  • Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
  • Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
  • Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
  • Neonatal period
  • Gestational age Any, not restricted
  • Postnatal age 0 days to 0 days
Follow-up From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.

Infant death, enrolment to 72 hours Primary endpoint

  1. 74 of 1,606 infants in the Immediate KMC (intervention) arm

    Measure
    Infants who died (count)
    Value
    74 infants
    Reported as
    74/1606 (4.6%)
    Interval
    Not applicable
    Denominator
    n = 1,606 (As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1609 infants were assigned to this arm.)
    Time window
    Enrolment to 72 hours of age

  2. 92 of 1,599 infants in the Conventional care, then KMC after stabilization (control) arm

    Measure
    Infants who died (count)
    Value
    92 infants
    Reported as
    92/1599 (5.8%)
    Interval
    Not applicable
    Denominator
    n = 1,599 (As reported in Table 3 of the author accepted manuscript only, not checked against the version of record. The fetched text does not state the basis. 1602 infants were assigned to this arm.)
    Time window
    Enrolment to 72 hours of age

  3. Immediate KMC (intervention) compared with Conventional care, then KMC after stabilization (control)

    Measure
    Adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)
    Value
    0.77 ratio
    Reported as
    aRR 0.77 (0.58 to 1.04), P=0.09
    Interval
    0.58 to 1.04 (95% confidence interval)
    Denominator
    Not applicable (basis: Comparison of the two per-arm rows above)
    Time window
    Enrolment to 72 hours of age

Caveats

  • Limitations. One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3). Fewer deaths in this window make the estimate less precise. The per-arm denominators (1606 and 1599) come from the author manuscript's Table 3 only, its text does not state their basis, and they were not checked against the version of record.

Sources and citations (4)

  1. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Abstract, RESULTS, sentence 3: "relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09"
    How it applies
    Abstract of the primary report, for the same infants and time window as this context.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    5dde5eaa4d684f398f7f3cfab05816eb73207b8adbaac5c4163e7e480567ecf6
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  2. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, row 2 (death between enrolment and 72 hours of age): 74/1606 (4.6%) and 92/1599 (5.8%)
    How it applies
    Author accepted manuscript (CC BY 4.0); not checked against the version of record.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  3. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, column header: "Adjusted RR (95%CI)"
    How it applies
    The ratios are adjusted, not crude; see the Table 3 footnote.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  4. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Discussion, para 5: "20% of infants 1.0 to <1.8 kg born in study hospitals were not enrolled because mother or newborn was too sick"
    How it applies
    Limits who the result describes.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

In plain words

Fewer babies in the immediate skin-to-skin group had a recorded low temperature (under 36 °C at the armpit) during their hospital stay: 90 of 1609 versus 133 of 1602 (adjusted risk ratio 0.65, 95% CI 0.51 to 0.83).

Applies to Newborn
  • Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
  • Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
  • Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
  • Neonatal period
  • Gestational age Any, not restricted
  • Postnatal age 0 days to 0 days
Follow-up From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.

Hypothermia (iKMC definition) Secondary endpoint

  1. 90 of 1,609 infants in the Immediate KMC (intervention) arm

    Measure
    Infants with at least one hypothermia episode (count)
    Value
    90 infants
    Reported as
    90/1609 (5.6%)
    Interval
    Not applicable
    Denominator
    n = 1,609 (As reported in Table 3 of the author accepted manuscript. It equals the number assigned to this arm.)
    Time window
    From 2 hours after randomization to hospital discharge

  2. 133 of 1,602 infants in the Conventional care, then KMC after stabilization (control) arm

    Measure
    Infants with at least one hypothermia episode (count)
    Value
    133 infants
    Reported as
    133/1602 (8.3%)
    Interval
    Not applicable
    Denominator
    n = 1,602 (As reported in Table 3 of the author accepted manuscript. It equals the number assigned to this arm.)
    Time window
    From 2 hours after randomization to hospital discharge

  3. Immediate KMC (intervention) compared with Conventional care, then KMC after stabilization (control)

    Measure
    Adjusted risk ratio, immediate vs control (log-binomial regression, adjusted for clustering from multiple births and for site, delivery mode, multiple pregnancy, age at randomization, infant sex and weight, maternal schooling and age, household toilet and family income, per the Table 3 footnote)
    Value
    0.65 ratio
    Reported as
    aRR 0.65 (0.51 to 0.83)
    Interval
    0.51 to 0.83 (95% confidence interval, not adjusted for multiplicity (Table 3 footnote))
    Denominator
    Not applicable (basis: Comparison of the two per-arm rows above)
    Time window
    From 2 hours after randomization to hospital discharge

Caveats

  • Limitations. Secondary outcome. Its confidence interval is not adjusted for multiplicity, and the authors say such intervals should not be used to infer definitive effects. Temperatures were measured in an open-label trial. The trial's hypothermia definition differs from other studies. One trial in five tertiary hospitals in low- and middle-income countries, with an open-label design. It stopped early for benefit before reaching its target of 4200 infants. About 20% of infants in the eligible weight band were not enrolled because mother or baby was too sick. The authors say the effect of starting early cannot be separated from the mother's continuous presence (author manuscript, Discussion para 5), and that applicability to low-mortality, high-resource settings is untested (author manuscript, Discussion para 3).

Sources and citations (3)

  1. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, hypothermia row: "90/1609 (5.6%) 133/1602 (8.3%) 0.65 (0.51–0.83)"
    How it applies
    Author accepted manuscript (CC BY 4.0); not checked against the version of record.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  2. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, footnote 1: "Any instance of axillary temperature <36ºC at any time from 2 hours after randomization until discharge from hospital."
    How it applies
    The trial's own hypothermia definition.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

  3. Background Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

    Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

    Locator
    Table 3, footnote dagger: "The 95% confidence intervals for secondary outcomes are not adjusted for multiplicity and should not be used to infer definitive intervention effects."
    How it applies
    The authors' own caution on this secondary outcome.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
    Reuse basis
    Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

Claims and evidence

Context Liveborn infants weighing 1.0 to under 1.8 kg at birth in five tertiary hospitals in sub-Saharan Africa and India (iKMC trial)

Recipient
Newborn
Population
Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
Care setting
Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
Geography
Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
Life stage
Neonatal period
Gestational age
Any, not restricted
Postnatal age
0 days to 0 days
Follow-up
From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.
Eligibility: 4 inclusion criteria; 8 exclusion criteria
Included
  • Liveborn infant
  • Birth weight 1.0 kg to under 1.8 kg
  • Any gestational age, mode of delivery, or singleton or twin status
  • Enrolled with the mother within 2 hours of birth
Excluded
  • Mother younger than 15 years
  • Mother, or the guardian of a minor mother aged 15 to 17, unable or unwilling to consent
  • Triplets or higher-order multiples
  • Mother unlikely to provide KMC within the first 3 days (registry examples: eclampsia, shock, major surgery)
  • Cannot be enrolled within 2 hours of birth
  • Residence outside the study area
  • Infant unable to breathe spontaneously by 1 hour of age
  • Major congenital malformation (registry: one that interferes with, or is interfered with by, the intervention)

  • Description Evidence stage not applicable Certainty not assessed

    The iKMC trial stopped enrolling babies early because its data and safety monitoring board found fewer deaths with immediate skin-to-skin care.

    Source problem. A cited source is unknown, not verified. Check the sources before relying on this claim.

    Applies to Newborn
    • Liveborn infants with a birth weight of 1.0 to under 1.8 kg (abstract: "between 1.0 and 1.799 kg"), of any gestational age, singleton or twin, by any mode of delivery, enrolled with their mothers within 2 hours of birth. About 20% of infants in this weight band born in the study hospitals were not enrolled because mother or newborn was too sick.
    • Tertiary hospitals. Intervention infants: a Mother-NICU (a neonatal intensive care unit with beds for mothers), then a KMC ward. Control infants: the NICU without the mother, then a KMC ward after stabilization.
    • Ghana (Kumasi), India (New Delhi), Malawi (Blantyre), Nigeria (Ile-Ife) and Tanzania (Dar es Salaam); cities per ANZCTR. The ICTRP mirror of the CTRI record does not name the fifth country; it lists it only as other.
    • Neonatal period
    • Gestational age Any, not restricted
    • Postnatal age 0 days to 0 days
    Follow-up From enrolment to 28 days of age, with a home visit on day 29. The second primary outcome window was enrolment to 72 hours.
    Certainty method
    Not assessed
    Limitations
    The registries disagree on the trial's status: ANZCTR records it as stopped early, while the WHO ICTRP mirror of the CTRI record gives its status as completed. The primary CTRI record could not be fetched. This is recorded, not reconciled.
    Last checked
    Not recorded
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

      Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

      Locator
      Abstract, RESULTS, last sentence: "The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality"
      How it applies
      Abstract of the primary report, for the same infants and time window as this context.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      5dde5eaa4d684f398f7f3cfab05816eb73207b8adbaac5c4163e7e480567ecf6
      Reuse basis
      Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

    2. Supports Effect of immediate Kangaroo Mother Care on neonatal mortality for mothers and babies

      Registry · Australian New Zealand Clinical Trials Registry · Edition Record as last updated 2021-04-07. Submitted 2018-09-10 and registered 2018-11-19, marked as retrospectively registered. Universal trial number U1111-1219-1230. · anzctr: ACTRN12618001880235

      Locator
      Recruitment, Reason for early stopping
      How it applies
      ANZCTR record as last updated 2021-04-07.
      Retrieved
      Source effective date
      2021-04-07
      Source state
      Current
      Snapshot hash
      3db33e1ff7a7695daedf52ac75f4a3dcdd1a7a29cd4bf650354891f0b8cceb11
      Reuse basis
      Short factual extraction. The page states that all rights are reserved, and lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the page states all rights reserved, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.

    3. Supports Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight

      Publication · Massachusetts Medical Society (N Engl J Med 384(21):2028-2038) · Edition Version of record not fetched (HTTP 403). The abstract comes from PubMed. Full-text facts come from the PMC author accepted manuscript PMC8108485. · Published 2021-05-27 · doi: 10.1056/NEJMoa2026486

      Locator
      Methods, Statistical analysis, para 1: "After the second interim analysis, the DSMB recommended stopping enrolment in the trial because of a clear benefit in neonatal survival."
      How it applies
      Author accepted manuscript (CC BY 4.0); not checked against the version of record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac
      Reuse basis
      Bibliographic metadata and short factual extraction. The PMC author accepted manuscript is licensed CC BY 4.0 and is committed at research/snapshots/pmc-PMC8108485.xml. Attribution: WHO Immediate KMC Study Group, N Engl J Med 2021;384:2028-2038, doi:10.1056/NEJMoa2026486, author accepted manuscript via PMC (PMC8108485). The version of record is not redistributed.

    4. Opposes Immediate skin to skin contact of the baby with mother or the surrogate

      Registry · Clinical Trials Registry - India, read through the WHO ICTRP mirror · Edition WHO ICTRP mirror, last refreshed on 24 November 2021. Registered 2018-08-17 (ICTRP marks it as not prospectively registered). The primary CTRI record could not be fetched: the http request timed out and the https request redirected to an error page. · ctri: CTRI/2018/08/015369

      Locator
      Main record fields, recruitment status
      How it applies
      WHO ICTRP mirror of CTRI, refreshed 2021-11-24; the primary register could not be fetched.
      Retrieved
      Source effective date
      2021-11-24
      Source state
      Unknown, not verified
      Snapshot hash
      ca9ae31bf890b23b30bf87167bc3cb5876db63618b15f9ad0c3658270c549e4c
      Reuse basis
      Short factual extraction from the ICTRP mirror, not the primary register. The page lists personal contact data, so its bytes were not saved. Public text is cite_only (fact-check decision of 2026-10-13): the terms of the CTRI record, read through the WHO ICTRP mirror, are unverified, so public pages state the facts in the atlas's own words, with a citation and a link. Numbers and dates still bind through the quote table.

Record details

Record id
maternal:ikmc-study
Content hash
eafb76f42be76b70dd8346ea4c1cccf73f688b14957c482edefc716a62ab5ea5