{ "release_id": "15708f235d73cd42", "id": "maternal:ikmc-study", "owner": "maternal", "kind": "study", "slug": "ikmc-study", "name": "WHO Immediate KMC Study (iKMC)", "aliases": [ "iKMC", "I-KMC" ], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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\".", "editorial_state": "draft", "last_substantive_edit": "2026-10-09", "last_evidence_check": null, "next_review_due": null, "external_ids": [ { "namespace": "anzctr", "value": "ACTRN12618001880235" }, { "namespace": "ctri", "value": "CTRI/2018/08/015369" } ], "navigation": { "maternal": { "life-stage": [ "newborn" ] } }, "payload": { "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.", "drug_phase": "not_applicable", "registry_statuses": [ { "status": "Stopped early", "snapshot": "maternal:anzctr-actrn12618001880235-2026-10-09" }, { "status": "Completed", "snapshot": "maternal:ictrp-ctri-2018-08-015369-2026-10-09" } ], "start_date": { "date": "2017-12-01", "type": null, "snapshot": "maternal:anzctr-actrn12618001880235-2026-10-09" }, "primary_completion_date": null, "completion_date": null, "countries": [ { "code": "GH", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "IN", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "MW", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "NG", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, { "code": "TZ", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" } ], "care_setting": { "description": "Five tertiary-level hospitals. The intervention arm used a Mother-NICU, a newborn intensive care unit with beds for mothers.", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, "stopped_early": { "scope": "enrollment", "date": null, "reason": "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.", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" }, "enrollment": [ { "count": 3211, "basis": "randomized", "unit": "infants", "snapshot": "maternal:pubmed-34038632-2026-10-09" }, { "count": 2944, "basis": "randomized", "unit": "mothers", "snapshot": "maternal:pmc-pmc8108485-2026-10-09" } ], "arms": [ { "id": "maternal:ikmc-study-arm-immediate", "label": "Immediate KMC (intervention)", "intervention": "maternal:immediate-kmc", "description": "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." }, { "id": "maternal:ikmc-study-arm-control", "label": "Conventional care, then KMC after stabilization (control)", "intervention": null, "description": "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": [ { "id": "maternal:f-ikmc-28d-immediate", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 191, "reported_text": "191/1596 (12.0%)", "unit": "infants", "denominator": 1596, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-28d-control", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 249, "reported_text": "249/1587 (15.7%)", "unit": "infants", "denominator": 1587, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-28d-arr", "outcome_id": "maternal:outcome-death-enrolment-to-28d", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-28d-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_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)", "numeric_value": 0.75, "reported_text": "aRR 0.75 (0.64 to 0.89), P=0.001", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Enrolment to 28 days of age", "estimate_lower": 0.64, "estimate_upper": 0.89, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-ikmc-72h-immediate", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 74, "reported_text": "74/1606 (4.6%)", "unit": "infants", "denominator": 1606, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-72h-control", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_measure": "infants who died (count)", "numeric_value": 92, "reported_text": "92/1599 (5.8%)", "unit": "infants", "denominator": 1599, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-72h-arr", "outcome_id": "maternal:outcome-death-enrolment-to-72h", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-72h-mortality", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "primary", "effect_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)", "numeric_value": 0.77, "reported_text": "aRR 0.77 (0.58 to 1.04), P=0.09", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "Enrolment to 72 hours of age", "estimate_lower": 0.58, "estimate_upper": 1.04, "interval_method": "95% confidence interval", "interval_status": null }, { "id": "maternal:f-ikmc-hypothermia-immediate", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_measure": "infants with at least one hypothermia episode (count)", "numeric_value": 90, "reported_text": "90/1609 (5.6%)", "unit": "infants", "denominator": 1609, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-hypothermia-control", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-control", "comparator_arm_id": null, "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_measure": "infants with at least one hypothermia episode (count)", "numeric_value": 133, "reported_text": "133/1602 (8.3%)", "unit": "infants", "denominator": 1602, "denominator_status": null, "denominator_basis": "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", "estimate_lower": null, "estimate_upper": null, "interval_method": null, "interval_status": "not_applicable" }, { "id": "maternal:f-ikmc-hypothermia-arr", "outcome_id": "maternal:outcome-hypothermia-ikmc", "context_id": "maternal:ctx-ikmc-newborns-1000-1799g", "arm_id": "maternal:ikmc-study-arm-immediate", "comparator_arm_id": "maternal:ikmc-study-arm-control", "claim_id": "maternal:claim-ikmc-hypothermia", "snapshot_id": "maternal:pmc-pmc8108485-2026-10-09", "endpoint_role": "secondary", "effect_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)", "numeric_value": 0.65, "reported_text": "aRR 0.65 (0.51 to 0.83)", "unit": "ratio", "denominator": null, "denominator_status": "not_applicable", "denominator_basis": "Comparison of the two per-arm rows above", "time_window": "From 2 hours after randomization to hospital discharge", "estimate_lower": 0.51, "estimate_upper": 0.83, "interval_method": "95% confidence interval, not adjusted for multiplicity (Table 3 footnote)", "interval_status": null } ] }, "content_digest": "eafb76f42be76b70dd8346ea4c1cccf73f688b14957c482edefc716a62ab5ea5", "review": { "content_digest": "eafb76f42be76b70dd8346ea4c1cccf73f688b14957c482edefc716a62ab5ea5", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "15708f235d73cd42", "id": "maternal:claim-ikmc-stopped-early", "owner": "maternal", "subject_entity_id": "maternal:ikmc-study", "category": "descriptive", "statement": "The iKMC trial stopped enrolling babies early because its data and safety monitoring board found fewer deaths with immediate skin-to-skin care.", "context": { "id": "maternal:ctx-ikmc-newborns-1000-1799g", "label": "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_min_days": null, "gestational_age_max_days": null, "postnatal_age_min_days": 0, "postnatal_age_max_days": 0, "gestational_age_status": "any", "postnatal_age_status": null, "followup_description": "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": { "inclusion": [ "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" ], "exclusion": [ "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)" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": null, "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "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\"", "applicability_note": "Abstract of the primary report, for the same infants and time window as this context.", "snapshot": { "id": "maternal:pubmed-34038632-2026-10-09", "retrieved_at": "2026-10-09T15:56:27Z", "content_hash": "5dde5eaa4d684f398f7f3cfab05816eb73207b8adbaac5c4163e7e480567ecf6", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ikmc-nejm-2021", "source_type": "publication", "title": "Immediate \"Kangaroo Mother Care\" and Survival of Infants with Low Birth Weight", "canonical_url": "https://doi.org/10.1056/NEJMoa2026486", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa2026486", "publication_date": "2021-05-27", "publisher": "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.", "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.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Recruitment, Reason for early stopping", "applicability_note": "ANZCTR record as last updated 2021-04-07.", "snapshot": { "id": "maternal:anzctr-actrn12618001880235-2026-10-09", "retrieved_at": "2026-10-09T15:57:53Z", "content_hash": "3db33e1ff7a7695daedf52ac75f4a3dcdd1a7a29cd4bf650354891f0b8cceb11", "source_effective_date": "2021-04-07", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ikmc-anzctr", "source_type": "registry", "title": "Effect of immediate Kangaroo Mother Care on neonatal mortality for mothers and babies", "canonical_url": "https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001880235", "identifier_namespace": "anzctr", "identifier_value": "ACTRN12618001880235", "publication_date": null, "publisher": "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.", "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.", "public_text": "cite_only" } }, { "evidence_role": "supports", "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.\"", "applicability_note": "Author accepted manuscript (CC BY 4.0); not checked against the version of record.", "snapshot": { "id": "maternal:pmc-pmc8108485-2026-10-09", "retrieved_at": "2026-10-09T15:57:07Z", "content_hash": "0945a417a4ffacfded839e4e8df7cf03c99c581e34fbca8ddd6daa7229b79bac", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ikmc-nejm-2021", "source_type": "publication", "title": "Immediate \"Kangaroo Mother Care\" and Survival of Infants with Low Birth Weight", "canonical_url": "https://doi.org/10.1056/NEJMoa2026486", "identifier_namespace": "doi", "identifier_value": "10.1056/NEJMoa2026486", "publication_date": "2021-05-27", "publisher": "Massachusetts Medical Society (N Engl J Med 384(21):2028-2038)", "edition": "Version of record not fetched (HTTP 403). 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The version of record is not redistributed.", "public_text": "quote" } }, { "evidence_role": "opposes", "locator": "Main record fields, recruitment status", "applicability_note": "WHO ICTRP mirror of CTRI, refreshed 2021-11-24; the primary register could not be fetched.", "snapshot": { "id": "maternal:ictrp-ctri-2018-08-015369-2026-10-09", "retrieved_at": "2026-10-09T15:58:10Z", "content_hash": "ca9ae31bf890b23b30bf87167bc3cb5876db63618b15f9ad0c3658270c549e4c", "source_effective_date": "2021-11-24", "public_archive_url": null, "source_state": "unknown" }, "source": { "id": "maternal:ikmc-ctri", "source_type": "registry", "title": "Immediate skin to skin contact of the baby with mother or the surrogate", "canonical_url": "http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21832", "identifier_namespace": "ctri", "identifier_value": "CTRI/2018/08/015369", "publication_date": null, "publisher": "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.", "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.", "public_text": "cite_only" } } ], "review": { "content_digest": "69d7ec77aeeceb89e5f979ed517273e5ebc62f471675681fa6fd67c28146760d", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-ikmc-stopped-early.json" } ], "decisions": [], "relationships": { "outgoing": [ { "predicate": "investigates", "label": "Tests immediate KMC", "clinical_claim_not_fact": false, "other_entity_id": "maternal:immediate-kmc", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "investigates", "label": "Enrolled infants weighing 1.0 to under 1.8 kg at birth", "clinical_claim_not_fact": false, "other_entity_id": "maternal:low-birth-weight", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "sponsored_by", "label": "Primary sponsor (ANZCTR, ICTRP)", "clinical_claim_not_fact": false, "other_entity_id": "maternal:who", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "funded_by", "label": "Funder (abstract, ANZCTR, ICTRP)", "clinical_claim_not_fact": false, "other_entity_id": "maternal:gates-foundation", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "results_reported_in", "label": "Primary results, NEJM 2021", "clinical_claim_not_fact": false, "other_entity_id": "maternal:pub-ikmc-nejm-2021", "other_entity_in_atlas": true, "claim_id": null } ], "incoming": [ { "predicate": "related_to", "label": "Related to", "clinical_claim_not_fact": false, "other_entity_id": "maternal:idea-immediate-kmc-high-resource-nicu", "other_entity_in_atlas": true, "claim_id": null } ] }, "page_path": "studies/ikmc-study/", "context_path": "api/v1/context/maternal--ikmc-study.md" }