Rigor Reviewed

Rigor-Reviewed Manuscript

Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.

Name: Adcurare Rigor Record — Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
Item: Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
Rating: 96
Author: Adcurare

Tumukunde V, Medvedev MM, Tann CJ, Mambule I, Pitt C, Opondo C, Kakande A, Canter R, Haroon Y, Kirabo-Nagemi C, Abaasa A, Okot W, Katongole F, Ssenyonga R, Niombi N, Nanyunja C, Elbourne D, Greco G, Ekirapa-Kiracho E, Nyirenda M, Allen E, Waiswa P, Lawn JE, OMWaNA Collaborative Authorship Group

Paper source

Read full text (PMC)Journal

Embed this Rigor badge

Adcurare Rigor Review — 3.75★ (Adequate), 0 critical, 0 high issues for “Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.”

Links back to this Rigor Record.

Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsCitations & links (capped) ×6−1★
ReportingData & code availability partially met−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: HighReviewer agreement: highEngine: 7.6.0Source: full text

Not verified in this report

Declared data/code links were not checked for liveness or content.

Problems surfaced2 types

Data/code availability incomplete
References not resolvable to a published paper

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

9 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 14 tests: 14 consistent, 0 inconsistent, 14 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites the iKMC trial and the Gambia eKMC trial, notes their limitations (underpowering, lack of economic data, sub-Saharan Africa focus), and explains why the OMWaNA trial is needed. The rationale for comparing KMC before stabilisation vs standard care is clearly linked to the evidence gap and WHO guideline changes. The limitations of previous work are acknowledged and addressed by the study design and embedded economic evaluation.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior research on KMC, describing the evidence gap, and providing a logical rationale for the study.

Evidence

direct quote[Introduction, paragraphs 2–4]

“One trial coordinated by WHO (the iKMC trial) ... reported that immediate KMC led to a 25% reduction in their secondary outcome of mortality within 28 days ... Another trial conducted in a level 2 neonatal unit in The Gambia found no reduction in mortality ... this study was underpowered because of improvements in the quality of standard care”

direct quote[Introduction, paragraph 4]

“We aimed to compare the effectiveness and safety of KMC initiated before stabilisation versus standard care among neonates ≤2000 g in sub-Saharan Africa. Additionally, we aimed to assess the incremental costs and cost-effectiveness of this intervention from the societal perspective.”

paraphrase[Introduction, paragraph 3]

“The introduction notes that previous studies had not evaluated costs of KMC before stabilisation or household opportunity costs, which the OMWaNA trial includes.”

PASSReviewer 2· 95% conf

The scientific premise is well-established. Prior work on KMC, including the iKMC and eKMC trials, is cited with their strengths and limitations, providing a clear rationale for the study.

Evidence

direct quote[Introduction, paragraph 3]

“One trial coordinated by WHO (the iKMC trial), which recruited newborns weighing 1000–1799 g in five tertiary-level hospitals with neonatal intensive care (level 3) in sub-Saharan Africa and India, reported that immediate KMC led to a 25% reduction in their secondary outcome of mortality within 28 days”

direct quote[Introduction, paragraph 3]

“The findings of these two trials left an evidence gap regarding the effects of immediate KMC at facilities without neonatal intensive care, where most births in LMICs occur, and questions regarding possibly lower impact in sub-Saharan Africa.”

direct quote[Introduction, paragraph 5]

“Indeed, there are few economic evaluations of KMC overall.”

The study is an individually randomised parallel-group trial with computer-generated random allocation, permuted blocks of varying sizes, stratification by birthweight and site, and allocation concealment via the REDCap database. The independent statistician was masked; parents and staff were not, which is expected given the intervention. A priori sample size calculation is provided (2188 neonates, 80% power, 5% significance, 20% attrition). Inclusion and exclusion criteria are clearly described. The primary analysis is intention-to-treat. The paper explicitly states the trial was conducted in accordance with CONSORT guidelines. All applicable sub-criteria are adequately reported.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial uses a rigorous randomised controlled design with computer-generated allocation, permuted blocks of varying sizes, stratification, and an intention-to-treat analysis; sample size is powered for the primary outcome; inclusion/exclusion criteria are pre-specified.

Evidence

direct quote[Methods, Randomisation and masking]

“A random allocation sequence was computer-generated with permuted blocks of varying sizes, stratified by birthweight (700–1000 g, 1000–1499 g, or 1500–2000 g) and recruitment site.”

direct quote[Methods, Statistical analysis]

“A sample size of 2188 neonates (1094 per group) was estimated to be required to detect an absolute reduction in 7-day mortality of 5·6% (22·4% relative reduction) at a 5% significance level (two-sided) and 80% power, allowing for 20% attrition.”

direct quote[Methods, Randomisation and masking]

“Masking of parents, caregivers, or health-care workers was not possible due to the nature of the KMC intervention; however, the independent statistician who conducted the analyses was masked to treatment allocation.”

paraphrase[Methods, Statistical analysis]

“The paper describes handling of missing data via multiple imputation for costs and assuming missingness at random for outcomes, but does not define outlier criteria or a pre-specified rule for excluding extreme values.”

PASSReviewer 2· 95% conf

The study design is rigorous for a pragmatic clinical trial: computer-generated randomisation, stratification, allocation concealment, masked analysis, pre-specified power calculation, and clear inclusion/exclusion criteria are reported.

Evidence

direct quote[Methods, Randomisation and masking]

“A random allocation sequence was computer-generated with permuted blocks of varying sizes, stratified by birthweight (700–1000 g, 1000–1499 g, or 1500–2000 g) and recruitment site.”

direct quote[Methods, Statistical analysis]

direct quote[Methods, Randomisation and masking]

Table 1 shows baseline characteristics for both groups, including birthweight, gestational age, sex, mode of delivery, birth location, and multiple-birth status. Mothers' age, education, and monthly income are reported. Sex is reported with both sexes enrolled, so a single-sex justification is not needed. Age and weight at screening are reported. Species/strain and housing conditions are not applicable for a human trial. Demographics are reported in adequate detail.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Key biological variables (birthweight, gestational age, sex, age at screening, multiple births) are reported in detail; demographics include maternal age, education, and income; no housing conditions or species/strain data are applicable as this is a human clinical trial.

Evidence

direct quote[Table 1]

“Female 558 (50·3%) / Male 552 (49·7%)”

direct quote[Table 1]

“Age at screening, h 20·3 (11·6) / 21·5 (11·5); Weight at screening, kg 1·5 (0·3) / 1·5 (0·3); Gestational age at screening, weeks 32·3 (2·4) / 32·3 (2·2)”

direct quote[Table 1]

“Age (actual or estimated), years 25·6 (6·0); Highest level of education: Primary school ... Secondary school ... University degree ... None; Monthly income, US$ 9·4 (0·0–54·9) / 5·5 (0·0–54·9)”

PASSReviewer 2· 95% conf

Key biological variables are well-reported: sex, age, gestational age, birthweight, and other demographics are provided in baseline tables with balanced distributions between groups.

Evidence

direct quote[Table 1]

“Female 558 (50·3%) / 561 (50·5%)”

direct quote[Table 1]

“Gestational age at screening, weeks 32·3 (2·4) / 32·3 (2·2); Weight at screening, kg 1·5 (0·3) / 1·5 (0·3)”

direct quote[Table 1]

“Age (actual or estimated), years 25·6 (6·0) / 25·6 (6·2)”

The paper states that the study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (16972). Written informed consent is described. The trial is reported in accordance with CONSORT and CHEERS guidelines, and the study was overseen by a steering committee and independent DSMB. This meets the criteria for adequate ethics reporting.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval from named committees (UVRI, UNCST, LSHTM) with protocol numbers is reported; written informed consent was obtained; regulatory compliance is stated.

Evidence

direct quote[Methods, Study design]

“The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (16972).”

direct quote[Methods, Participants]

“Written informed parental consent was obtained for all participants.”

direct quote[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines”

PASSReviewer 2· 95% conf

Ethical approvals from named committees and informed consent are clearly reported.

Evidence

direct quote[Methods, Study design]

direct quote[Methods, Participants]

“Written informed parental consent was obtained for all participants.”

direct quote[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines ( p 4).”

The study evaluates a care practice (kangaroo mother care), not a pharmacological or biological agent. Key software tools (REDCap, Stata 18.1, Microsoft Excel) are identified with versions. No antibodies, cell lines, mycoplasma testing, or organisms other than human neonates apply. The trial does not use a drug, biologic, or device as an investigational product, so reagents_identified is not applicable; the intervention and control procedures are adequately described. Software_tools_identified is adequate.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational product (KMC) is a care intervention, not a drug or biologic; no antibodies, cell lines, or other biological reagents are used; software and data capture systems are identified.

Evidence

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed with Stata (version 18.1).”

direct quote[Methods, Procedures]

“Data were captured electronically in REDCap”

direct quote[Methods, Economic evaluation]

“All analyses were performed with Microsoft Excel and Stata (version 18.1).”

PASSReviewer 2· 90% conf

The key resource of this clinical trial is the investigational product (KMC), which is described, and the study uses standard care with equipment and staff time, but these are not 'reagents' in the typical sense. Software tools for analysis are identified.

Evidence

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed with Stata (version 18.1).”

direct quote[Methods, Outcomes]

“Data were captured electronically in REDCap by use of trial-specific care report forms”

direct quote[Methods, Procedures]

“Neonates were naked, except for hat and diaper; placed prone and skin-to-skin on the caregiver’s chest; and secured using a KMC wrap.”

All statistical tests are named (modified Poisson regression, Cox proportional hazards, linear regression) with robust SEs. Exact p-values and 95% CIs are reported for primary and secondary outcomes. Effect sizes (RR, HR, mean differences) are reported with CIs. Software is identified (Stata 18.1, Excel). Data presentation includes forest plots and Kaplan-Meier curves; per-group n is clearly stated. Given the large sample and pre-specified analysis model, explicit normality testing is not required; the use of robust SEs and modified Poisson (which handles non-convergence) addresses key assumptions. Mathematical plausibility is not independently verifiable from the summary data, as means of continuous variables are reported; no arithmetic inconsistencies are evident.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named; effect sizes with 95% CIs and exact p-values are reported for most outcomes; software and data presentation meet expectations for a large clinical trial; assumptions are handled by design, though not explicitly tested.

Evidence

direct quote[Table 2]

“Risk ratio (95% CI) ... adjusted effect 0·97 (0·74 to 1·28); p=0·85”

direct quote[Table 2]

“p=0·85; p=0·23; p<0·0001; p=0·047”

direct quote[Methods, Statistical analysis]

“For all regression models, robust SEs were used to account for clustering of outcomes with multiple births.”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, including test names, adjustment for stratification and clustering, and software. Exact p-values and effect sizes with CIs are reported for primary and secondary outcomes.

Evidence

direct quote[Methods, Statistical analysis]

“Risk ratios (RRs) with 95% CI were estimated for 7-day and 28-day mortality and were compared between the intervention group and the control group with modified Poisson regression models.”

direct quote[Results, paragraph 2]

“adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85”

direct quote[Methods, Statistical analysis]

“All statistical analyses were performed with Stata (version 18.1).”

The paper states: 'Data from the study will be deposited online at LSHTM Data Compass, with access subject to approval.' This is a concrete repository (LSHTM Data Compass) but with access subject to approval, which is a form of managed access. It is not a fully open dataset. No accession number is provided. Custom code sharing is not mentioned. Because the data availability statement promises deposition but the access is restricted, and code is not shared, the applicable criteria are partially met.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositINADEQUATE

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

A data availability statement is present; data will be deposited in a repository (LSHTM Data Compass) with approved access; no bespoke code is shared, but the trial is registered and the protocol is published.

Evidence

direct quote[Data sharing]

“Data from the study will be deposited online at LSHTM Data Compass (https://datacompass.lshtm.ac.uk/), with access subject to approval.”

direct quote[Methods, Statistical analysis]

“This trial is registered with ClinicalTrials.gov, NCT02811432”

WARNReviewer 2· 90% conf

A data availability statement is present but vague ('available on reasonable request' with an approval mechanism), and no code sharing is reported.

Evidence

direct quote[Data sharing]

“Data from the study will be deposited online at LSHTM Data Compass ( https://datacompass.lshtm.ac.uk/ ), with access subject to approval.”

absence[Data sharing]

No accession numbers are provided.

absence[Data sharing, Methods, Competing interests]

Code sharing is not mentioned.

The methods section is comprehensive, describing participant selection, randomisation, intervention details, outcome definitions, statistical methods, and economic analysis. The trial is registered. CONSORT and CHEERS checklists were submitted (supplementary). All pre-specified outcomes from the protocol are reported in the results, including non-significant ones. Limitations are discussed in detail (sample size assumptions, unmasking, missing data, site variation). Conclusions are proportional: the authors do not claim effectiveness on the primary outcome but note benefits in secondary outcomes and cost-effectiveness. Funding sources and a conflicts-of-interest statement are provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Methods are detailed and replicable; CONSORT and CHEERS guidelines are followed; all outcomes are reported; limitations and proportional conclusions are well addressed; funding and COI are declared.

Evidence

direct quote[Methods, Study design and Economic evaluation]

“This trial is reported in accordance with CONSORT guidelines (p 4). ... The economic evaluation is reported in accordance with CHEERS guidelines”

paraphrase[Table 2 and Results text]

“Table 2 reports all primary and secondary outcomes with effect sizes, CIs, and p-values, including non-significant results.”

direct quote[Discussion, final paragraph]

“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25% ... we observed lower reductions in mortality rate ... Variation between sites ... impossible to mask participants and hospital staff ... We were unable to include household costs at 28-day follow-up because few data were collected.”

PASSReviewer 2· 95% conf

Reporting is highly transparent: the protocol is published, CONSORT guidelines are followed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Methods, Study design / Abstract]

“This trial is reported in accordance with CONSORT guidelines ( p 4). This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov) , NCT02811432”

direct quote[Discussion, paragraph 2]

“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25% and the trial was powered to detect a relative risk reduction in the primary outcome (mortality at 7 days).”

direct quote[Acknowledgments / Declaration of interests]

“The OMWaNA trial was supported by a grant from the Joint Global Health Trials scheme ... We declare no competing interests.”

4 copyedit issues flagged: mostly consistency, other, clarity.

Checked 44 references: 38 verified — 6 unresolved.

Reproducibility

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Full text (74,612 chars)Analyzed: Jul 7, 2026

Read alongside

Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.

Read full text (PMC)

Journal

DOI

10.1016/S0140-6736(24)00064-3

Share this Rigor Review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://adcurare.com/verify/75b50b46-f9b7-4da1-8ac1-19392781c810" target="_blank" rel="noopener">
  <img src="https://adcurare.com/verify/75b50b46-f9b7-4da1-8ac1-19392781c810/badge" alt="Adcurare Rigor Review — 3.75★ (Adequate), 0 critical, 0 high issues for “Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Rigor Record.

Record fingerprint

8367bb2dd5f01cc3cad1e01a24df2e1d5946ff501f9d88816ead3cfd749ecd07

Verify via API

Issued Jul 7, 2026Engine 7.6.0

Adcurare assesses methodological rigor, not the importance of the findings. See how we evaluate →