Evidence map›Paper›PMID 34401686›Full record

ArticleEClinicalMedicine2021

Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial.

Helen Brotherton, Abdou Gai, Bunja Kebbeh, Yusupha Njie, Georgia Walker, Abdul K Muhammad, Saffiatou Darboe, Mamadou Jallow, Buntung Ceesay, Ahmadou Lamin Samateh and 4 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03555981 (A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03555981 naterminatednot on this map

A Randomised Controlled Trial of Early Continuous Kangaroo Mother Care Versus Standard Care on Survival of Hospitalised Unstable Neonates <2000g in The Gambia

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2018 to 2020Enrolled279ConditionsPreterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother CareArmsEarly Kangaroo Mother Care, Standard care
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 3 countries.

Helen BrothertonDepartment of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.
Abdou GaiMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Bunja KebbehMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Yusupha NjieMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Georgia WalkerDepartment of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.
Abdul K MuhammadMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Saffiatou DarboeMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Mamadou JallowMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Buntung CeesayMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Ahmadou Lamin SamatehMinistry of Health, Gambia Government, Banjul, Gambia.
Cally J TannDepartment of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.
Simon CousensDepartment of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.
Anna RocaMRC Unit The Gambia at LSHTM, Atlantic Road, Fajara, Gambia.
Joy E LawnDepartment of Infectious Disease Epidemiology and MARCH Centre, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, UK.
MRC Unit the Gambia · GMLondon School of Hygiene & Tropical Medicine · GBMinistry of Health and Social Welfare · GMUniversity College London Hospitals NHS Foundation Trust · GB

Funding

Medical Research Council MR/S004971/1Wellcome Trust
6 · The paper itself

Abstract

backgroundUnderstanding the effect of early kangaroo mother care on survival of mild-moderately unstable neonates <2000 g is a high-priority evidence gap for small and sick newborn care.

methodsThis non-blinded pragmatic randomised clinical trial was conducted at the only teaching hospital in The Gambia. Eligibility criteria included weight <2000g and age 1-24 h with exclusion if stable or severely unstable. Neonates were randomly assigned to receive either standard care, including KMC once stable at >24 h after admission (control) versus KMC initiated <24 h after admission (intervention). Randomisation was stratified by weight with twins in the same arm. The primary outcome was all-cause mortality at 28 postnatal days, assessed by intention to treat analysis. Secondary outcomes included: time to death; hypothermia and stability at 24 h; breastfeeding at discharge; infections; weight gain at 28d and admission duration. The trial was prospectively registered at www.clinicaltrials.gov (NCT03555981).

findingsRecruitment occurred from 23rd May 2018 to 19th March 2020. Among 1,107 neonates screened for participation 279 were randomly assigned, 139 (42% male [

interpretationThe trial had low power due to halving of baseline neonatal mortality, highlighting the importance of implementing existing small and sick newborn care interventions. Further mortality effect and safety data are needed from varying low and middle-income neonatal unit contexts before changing global guidelines.

Indexed as

aPSBI, (adapted Possible Severe Bacterial Infection)aSCRIP, (adapted Stability of Cardio-respiratory in Preterm infants)bCPAP, (bubble Continuous Positive Airway Pressure)CFR, (Case-fatality rate)CI, (confidence interval)CLSI, (Clinical & Laboratory Standards Institute)CONSORT, (Consolidated Standards of Reporting Trials)CSF, (Cerebral-Spinal Fluid)DSMB, (Data Safety Monitoring Board)EFSTH, (Edward Francis Small Teaching Hospital)eKMC trial, (early Kangaroo Mother Care before Stabilisation trial)GEE, (Generalized Estimating Equation)HR, (Hazard Ratio)ICH-GCP, (International Conference on Harmonisation – Good Clinical Practice)IQR, (Inter Quartile Range)ISO, (International organisation for standardisation)IV, (intravenous)Kangaroo methodKangaroo Mother CareKMC, (Kangaroo mother care)LMIC, (Low and middle-income countries)LSHTM, (London School of Hygiene & Tropical Medicine)MDR, (Multi-drug resistant)MortalityMRCG, (Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine)NA, (not applicable)NeonateNewbornNNU, (Neonatal Unit)PrematureRCT, (Randomised controlled trial)RD, (Risk difference)RDS, (Respiratory Distress Syndrome)RR, (Risk Ratio)SAE, (Serious Adverse Event)SDG, (Sustainable Development Goal)SD, (Standard Deviation)Skin-to-skin contactSSA, (Sub-Saharan Africa)SurvivalWHO, (World Health Organisation)

Identifiers

PMID34401686
PMCPMC8358420
OpenAlexW3188170566

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.