Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

Showing 6 appraisals

Randomised Controlled TrialEvidence: Weak
75CEBM

BMC public health

Little All Children in Focus (Little ACF) - evaluation of a parenting support programme for parents of children aged 1-2 years in Sweden: a randomised controlled trial

INTRODUCTION: The first two years of life affect health over the life course. Universal parenting support programmes may promote child health during these years but there is a lack of such evidence-based programmes. Our aim was to study the direct effects of a structured 4 sessions universal parenting programme for parents with children 1-2 years old, Little All Children in Focus, in Sweden. METHODS: A two-arm parallel randomised controlled superiority trial with 832 Swedish-speaking parents was conducted to evaluate the effectiveness of the Little All Children In Focus programme in comparison with an active control receiving four digital lectures on child development and parenthood. The participants completed questionnaires at baseline and post intervention measuring the primary outcomes: parenting self-efficacy and stress, coparenting quality, emotion regulation for parents and emotion regulation strategies for their children, and secondary outcome: child socioemotional development. A third research question concerned whether the intervention could engage and retain parents in groups. An intention-to-treat approach was applied using linear mixed models for analysing the effectiveness of the programme. RESULTS: Parents who participated in the programme demonstrated greater improvements in supportive emotion regulation strategies compared to the active control (β = 3.0, CI = 0.9 - 5.0), while no notable group differences emerged across the remaining outcome measures. The program demonstrated high levels of parental engagement and retention in group settings. CONCLUSIONS: Little All Children in Focus demonstrates potential in promoting supportive parenting emotion regulation strategies among Swedish speaking parents to 1-2-year-olds. The intervention also seems to have potential to engage parents. However, further evaluations must be conducted to provide a deeper understanding of the long-term impact of this universal parenting support programme. TRIAL REGISTRATION: The study protocol https://rdcu.be/eAxn2 was published at www. CLINICALTRIALS: gov with registration number: NCT05445141 (registered on July 06, 2022).

21 May 2026

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Randomised Controlled TrialEvidence: Moderate
50CEBM

African journal of reproductive health

Effect of a herbal galactagogic formula combined with auricular acupressure on breast milk production and hormonal profiles in women with postpartum hypogalactia: A randomized controlled study

Postpartum hypogalactia is a common condition that may impair breastfeeding and maternal-infant health. This randomized controlled study evaluated the efficacy of a herbal galactagogic decoction combined with auricular acupressure in improving lactation outcomes. A total of 104 women with postpartum hypogalactia were enrolled between July 2023 and June 2025 and randomly assigned to a control group (auricular acupressure alone, n=52) or an intervention group (auricular acupressure plus herbal decoction, n=52) for 2 weeks. Primary outcomes included breast milk production and formula supplementation, while secondary outcomes comprised serum hormone levels (estradiol, progesterone, and prolactin), symptom scores, psychological status, and clinical effectiveness. Both groups showed significant post-treatment improvements (P<0.05). Compared with the control group, the intervention group demonstrated lower estradiol and progesterone levels, higher prolactin levels, increased milk production, and reduced formula supplementation (P<0.05). Symptom scores and anxiety/depression levels were also significantly improved. The overall effective rate was higher in the intervention group (96.15% vs 80.77%, P<0.05), with comparable safety profiles. This combined therapy appears to be a safe and effective complementary approach for improving lactation in women with postpartum hypogalactia. L’hypogalactie post-partum est une affection fréquente pouvant compromettre l’allaitement et la santé maternelle et infantile. Cette étude randomisée contrôlée a évalué l’efficacité d’une décoction galactagogue à base de plantes associée à l’acupression auriculaire pour améliorer les résultats de lactation. Au total, 104 femmes atteintes d’hypogalactie post-partum ont été recrutées entre juillet 2023 et juin 2025 et réparties aléatoirement en un groupe témoin (acupression auriculaire seule, n=52) et un groupe intervention (acupression auriculaire associée à une décoction à base de plantes, n=52) pendant 2 semaines. Les critères de jugement principaux comprenaient la production de lait maternel et le volume de supplémentation en lait artificiel, tandis que les critères secondaires incluaient les niveaux hormonaux sériques (estradiol, progestérone et prolactine), les scores symptomatiques, l’état psychologique et l’efficacité clinique. Les deux groupes ont montré des améliorations significatives après le traitement (P<0,05). Comparé au groupe témoin, le groupe intervention présentait des niveaux plus faibles d’estradiol et de progestérone, des niveaux plus élevés de prolactine, une production de lait accrue et une réduction de la supplémentation (P<0,05). Les scores symptomatiques ainsi que les niveaux d’anxiété et de dépression ont également été significativement améliorés. Le taux global d’efficacité était plus élevé dans le groupe intervention (96,15 % vs 80,77 %, P<0,05), sans différence significative en termes d’effets indésirables. Cette thérapie combinée pourrait constituer une approche complémentaire sûre et efficace pour améliorer la lactation chez les femmes présentant une hypogalactie post-partum.

18 May 2026

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Randomised Controlled TrialEvidence: Moderate
80CEBM

Philosophical transactions of the Royal Society of London. Series B, Biological sciences

Is iron supplementation likely to impair linear growth and gut microbiota composition of Myanmar young children when complementary feeding is not optimized? A randomized controlled trial.

Iron deficiency, with or without anemia, remains a major public health concern among young children in Myanmar. While iron supplementation is widely recommended, its potential adverse effects on growth and gut microbiota warrant investigation, particularly in contexts of poor complementary feeding. To assess the effects of iron supplementation, with or without complementary feeding recommendations (CFRs), on micronutrient status, linear growth and gut microbiota composition among Myanmar children aged 12-23 months, a 24-week randomized controlled trial was conducted in Ayeyarwady Region of Myanmar. Fourteen clusters (villages/wards) were randomized to receive CFRs or not, and children within the clusters were randomized to receive daily aqueous iron or placebo, creating four arms: Placebo (n = 104), CFR (n = 112), Fe (n = 105) and CFRFe (n = 112) totalling 433 children. All intervention groups (CFR, Fe, CFRFe) improved haemoglobin and reduced anaemia risk compared with Placebo (AOR = 0.31 (0.15-0.62), 0.15 (0.07-0.32), 0.14 (0.07-0.31), respectively). CFR and CFRFe also improved zinc status. However, iron-alone (Fe) increased the stunting risk (AOR= 2.74 (1.04-7.23)), while CFRFe did not. No significant effects were observed on gut microbiota composition. Aqueous iron supplementation may impair linear growth when diets are not optimized; combining supplements with optimized complementary feeding may support healthier outcomes. This article is part of the theme issue 'Biological, biomedical and environmental drivers of stunting'.

17 May 2026

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Systematic ReviewEvidence: Moderate
80CEBM

The Cochrane database of systematic reviews

Vitamin D for preventing acute respiratory infections in children up to five years of age

RATIONALE: Acute respiratory infections (ARIs) are a leading cause of morbidity and mortality in children under five years of age and contribute to healthcare visits and hospitalisations globally. Vitamin D deficiency is common amongst pregnant women and young children. Given that vitamin D supplementation is safe, affordable, and easy to administer, its potential to reduce ARI-related healthcare visits holds substantial public health relevance. This review evaluates the benefit and harm of vitamin D supplementation in preventing ARI-related healthcare visits in young children, aiming to inform supplementation policies during pregnancy and early childhood. OBJECTIVES: To determine the benefit and harm of vitamin D supplementation for preventing ARIs in children up to five years of age. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, WHO Global Index Medicus, and four clinical trial registries on 18 March 2025. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) comparing vitamin D to placebo, or a higher dose (≥ 1000 IU) versus a lower dose (≤ 1000 IU) administered from early pregnancy through to five years of age. We excluded studies involving children with chronic respiratory or systemic conditions. OUTCOMES: Critical outcomes: 1) healthcare visits made by children for an ARI: (a) the proportion of children with healthcare visits made for ARIs; (b) the mean number of healthcare visits made for ARIs per child; and 2) hypercalcaemia: the number of pregnant women and children with hypercalcaemia. RISK OF BIAS: We assessed risk of bias using the Cochrane risk of bias (RoB) 1 tool for outcomes reported in the summary of findings tables. SYNTHESIS METHODS: We synthesised outcome data using meta-analyses, calculating risk ratios (RR) for dichotomous, and mean differences (MD) for continuous outcomes, each with 95% confidence intervals (CI). Where meta-analysis was not feasible, we summarised the results narratively. We used GRADE to assess the certainty of the evidence for pre-specified outcomes. INCLUDED STUDIES: We included 107 RCTs involving 31,521 participants. Vitamin D supplementation was administered during pregnancy, early childhood, or both, and in some cases to both infants and lactating mothers. Interventions used vitamin D2, D3, both, or unspecified forms, with dosages ranging from daily administration to large single or quarterly boluses. Most were delivered orally, typically on a daily schedule, but also weekly or quarterly, over durations ranging from a single dose to 18 months. Settings included hospitals, day-care centres, communities, and homes. SYNTHESIS OF RESULTS: Vitamin D supplementation may result in a slight reduction in the proportion of children who make ARI-related healthcare visits compared to placebo (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.91 to 1.00; P = 0.03; 10 studies, 2447 participants; low-certainty evidence), but probably does not reduce the mean number of ARI-related healthcare visits per child (mean difference (MD) 0.07, 95% CI -0.06 to 0.20; P = 0.32; 3 studies, 561 participants; moderate-certainty evidence). Comparisons between higher and lower doses of vitamin D probably do not reduce the proportion of children making ARI-related healthcare visits (RR 0.94, 95% CI 0.81 to 1.10; P = 0.46; 2 studies, 1382 participants; moderate-certainty evidence), and do not reduce the mean number of ARI-related healthcare visits per child (MD -0.10, 95% CI -0.59 to 0.39; P = 0.69; 1 study, 579 participants; low-certainty evidence). No cases of hypercalcaemia were reported among pregnant women in trials comparing vitamin D supplementation with placebo. In higher versus lower dose comparisons, supplementation may result in little to no difference in the risk of hypercalcaemia among pregnant women (RR 1.61, 95% CI 0.60 to 4.31; P = 0.34; 6 studies, 2379 participants; low-certainty evidence). Similarly, the evidence that vitamin D supplementation has little to no effect on the risk of hypercalcaemia in children, when compared with placebo, is very uncertain (RR 0.81, 95% CI 0.53 to 1.24; 7 studies, 1542 participants; very low-certainty evidence) and may result in little to no difference in the risk of hypercalcaemia in children when higher doses are compared to lower doses (RR 1.23, 95% CI 0.82 to 1.85; 7 studies, 1287 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: We found low-certainty evidence that vitamin D supplementation during pregnancy or early childhood may result in a slight reduction in the proportion of children under five years of age who make ARI-related healthcare visits, but probably does not reduce the mean number of healthcare visits for ARIs per child. This finding highlights the need for large, well-designed, placebo-controlled trials to confirm the potential benefit. We found moderate-certainty evidence that higher-dose vitamin D supplementation, compared with lower doses, probably does not reduce the proportion of children making healthcare visits for ARIs and does not reduce the mean number of ARI-related healthcare visits per child. Hypercalcaemia occurs infrequently in both pregnant women and children receiving vitamin D supplementation. Where hypercalcaemia could be measured, specifically in children receiving vitamin D versus placebo, vitamin D supplementation may have little to no effect on the risk of hypercalcaemia (very low-certainty evidence). In both children and pregnant women, a higher dose of vitamin D compared to a lower dose may result in little to no difference in the risk of hypercalcaemia (low-certainty evidence). FUNDING: This Cochrane review had no dedicated funding. REGISTRATION: Protocol (2022) DOI: 10.1002/14651858.CD015111.

2 May 2026

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Randomised Controlled TrialEvidence: Weak
50CEBM

European journal of pediatrics

Multi-directional phototherapy vs. unidirectional phototherapy from below for severe neonatal jaundice: a randomized pilot trial in home phototherapy

UNLABELLED: Severe neonatal jaundice is a common problem, carrying a risk of neurologic toxicity. Phototherapy has become the standard treatment for jaundiced infants, eliminating the need for exchange transfusion and the risk of neurotoxicity. We hypothesized that treatment with multi-directional phototherapy would be more rapid than with single-direction, high-intensity treatment from below (unidirectional) in the home setting. We performed a prospective, randomized, pilot trial comparing high-intensity multi-directional phototherapy to high-intensity unidirectional treatment in the home setting. Treatment time was determined from device timers. Serum bilirubin levels were obtained daily and as ordered by the pediatrician, serving as a basis for estimating the bilirubin reduction rates. Eight infants were treated with multi-directional phototherapy; nine were treated with unidirectional phototherapy. Multi-directional treatment was more rapid with treatment time of 15.1 ± 6.4 h vs. 25.1 ± 11.8 h; p = 0.05. The estimated rate of bilirubin reduction was more rapid with multi-directional phototherapy 0.40 ± 0.21 vs. 0.14 ± 0.10 mg/dL/h; p < 0.02. CONCLUSION: Multi-directional phototherapy was more rapid than treatment with unidirectional phototherapy in the home setting. TRIAL REGISTRATION: ISRCTN88608924 29 January 2026, retrospectively registered. WHAT IS KNOWN: •Home phototherapy for hyperbilirubinemia is safe and effective. •Treatment times with fiberoptic and wearable devices in the home setting can be lengthy and complicated by overheating and readmission. WHAT IS NEW: •Home phototherapy with multidirectional illumination is more effective than unidirectional undersurface phototherapy. •Multidirectional home phototherapy can lower bilirubin levels at a rate comparable to hospital devices.

15 Apr 2026

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Randomised Controlled TrialEvidence: Moderate
65CEBM

Psychological medicine

Maternal communication and attachment following a group singing intervention for postnatal depression: findings from the SHAPER-PND trial

BACKGROUND: Postnatal depression (PND) can disrupt maternal communication during early interactions, affecting infant socioemotional development. Singing is a natural form of caregiver-infant communication and a promising intervention to enhance maternal well-being and bonding. However, its effects on observed communication and perceived attachment in clinical PND populations remain underexplored. METHODS: Within the Scaling-Up Health-Arts Programs: Postnatal Depression trial, 199 mothers with PND were randomized 2:1 to a 10-week group singing intervention (Breathe Melodies for Mums) or a non-singing community activity. One hundred participants (singing = 70; control = 30) completed video-recorded interactions at baseline, week 10, and week 36. Maternal speech was coded using the Parental Cognitive Attributions and Mentalization Scale (PCAMS) for mentalization, affective tone, and attentional focus. Perceived maternal attachment was assessed separately via self-report using the Maternal Postnatal Attachment Scale. RESULTS: At week 10, singing mothers showed greater improvement in communication with their infants than controls, with about 1.7-fold higher proportions of mentalizing comments (p = 0.01), 1.4-fold more infant-focused speech (p < 0.001), 2.4-fold less parent-focused speech (p < 0.001), and fivefold less negative speech (p < 0.001). These effects were maintained at week 36. Perceived attachment improved significantly across both groups (p < 0.001), but only singing mothers showed further gains from week 10 to week 36 (p = 0.02), indicating continued strengthening of attachment perceptions. CONCLUSIONS: Group singing enhanced maternal communication and perceived attachment in mothers with PND. Findings support community-based, arts-informed interventions as accessible approaches to strengthen early relational health and complement perinatal mental healthcare.

8 Apr 2026

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