Securing the surgical field for mobilization of right-sided colon cancer using the duodenum-first multidirectional approach in laparoscopic surgery.

BACKGROUND: The aim of this study was to compare the short-term outcomes of the duodenum-first multidirectional approach (DMA) in laparoscopic right colectomy with those of the conventional medial approach to assess its safety and feasibility. METHODS: This retrospective study enrolled 120 patients who had laparoscopic surgery for right-sided colon cancer in our institution between April 2013 and December 2019. Fifty-four patients underwent colectomy using the multidirectional approach; among these, 20 underwent the DMA and 34 underwent the caudal-first multidirectional approach (CMA). Sixty-six patients underwent the conventional medial approach. Complications within 30 days of surgery were compared between the groups. RESULTS: There were 54 patients in the multidirectional group [29 females, median age 72 years (range 36-91 years)] and 66 in the medial group [42 females, median age 72 years (range 41-91 years)]. Total operative time was significantly shorter in multidirectional approach patients than conventional medial approach patients (208 min vs. 271 min; p = 0.01) and significantly shorter in patients who underwent the DMA compared to the CMA (201 min vs. 269 min; p < 0.001). Operative time for the mobilization procedure was also significantly shorter in patients who underwent the DMA (131 min vs. 181 min; p < 0.001). Blood loss and incidence of postoperative complications did not differ. In 77 patients with advanced T3/T4 tumors, the DMA, CMA, and conventional medial approach were performed in 13, 21, and 43 patients, respectively. Total operative time and operative time of the mobilization procedure were significantly shorter in patients undergoing DMA. Blood loss and incidence of postoperative complications did not differ. R0 resection was achieved in all patients with advanced tumors. CONCLUSIONS: The DMA in laparoscopic right colectomy is safe and feasible and can achieve R0 resection with a shorter operative time than the conventional medial approach, even in patients with advanced tumors.

Atrophic change of the abdominal rectus muscle significantly influences the onset of parastomal hernias beyond existing risk factors after end colostomy.

PURPOSE: To investigate optimal risk factors, including atrophy of the abdominal rectus muscle (ARM) for postoperative parastomal hernia (PH) in patients who underwent end colostomy at left lower quadrant. METHODS: This single-institution retrospective study included 91 patients who underwent end colostomy between April 2004 and December 2015. The surgical and long-term outcomes among patients with or without PH were collected and compared. RESULTS: Altogether, 22 (24.2%) patients had a PH including 15 (68.2%) patients with a simultaneous incisional hernia. Univariate analysis showed that older patients (71 ± 11.9 vs. 64 ± 12.2 years, p = 0.03) and those with higher body mass index (BMI) (23.8 ± 3.8 vs. 20.9 ± 3.3 kg/m2, p < 0.001) had a statistically significant relation with having PHs. Relative atrophy of left abdominal rectus muscle was more frequently found in patients with PH (ratio of left side/right side; caudal level and medial side: 0.66 vs. 0.92, p < 0.01, caudal level and lateral side: 0.95 vs. 1.03, p = 0.04). Multivariate analysis revealed that BMI > 25 kg/m2 [odds ratio (OR) 9.05, 95% confidence interval (CI) 2.06-39.76, p = 0.003] and atrophy of the left lower medial portion of the abdominal rectus muscle (OR 12.85, 95% CI 2.49-66.39, p = 0.002) were independent risk factors for PHs. Neither the laparoscopic approach nor the extraperitoneal route of the colostomy was proven to correlate with a lower rate of PHs. CONCLUSIONS: High BMI and atrophic change of ARM were significantly associated with PH development. Surgical techniques for prevention of atrophic change of ARM are expected to reduce the incidence of PHs.

Hypoxia-inducible factor 1α promotes interleukin 1ß and tumour necrosis factor α expression in lipopolysaccharide-stimulated human dental pulp cells.

AIM: To elucidate the role of HIF1α in pro-inflammatory cytokine mRNA expression from lipopolysaccharide (LPS)-stimulated human dental pulp cells (hDPCs). METHODOLOGY: mRNA expression of interleukin (IL) 1ß and tumour necrosis factor (TNF) α in LPS-stimulated hDPCs was determined by quantitative RT-PCR. Expression of nuclear factor kappa B (NFκB) p65 and phospho-NFκB p65 was analysed by Western blotting. Activation of NFκB signalling was measured by luciferase assay using a reporter vector containing an NFκB response element. Enforced expression of HIF1α was induced by transfection of expression vectors with native or constitutively active forms of HIF1α. Expression of HIF1α protein in hDPCs was evaluated by immunocytochemistry and Western blotting. One-way analysis of variance and the Tukey-Kramer test were performed to determine a significant difference (P < 0.05). RESULTS: mRNA expression of IL1ß and TNFα, protein expression of phospho-NFκB p65 and LPS-induced NFκB signalling activity were promoted in low oxygen conditions (1% O2 ; P < 0.05). These findings were replicated following enforced expression and stabilization of HIF1α in hDPCs. Dimethyloxalylglycine, an inhibitor of prolyl hydroxylase (a HIF1α degrading enzyme), promoted IL1ß and TNFα mRNA expression and NFκB signalling in LPS-stimulated hDPCs (P < 0.05). HIF1α expression was detected in hDPCs cultured in low oxygen conditions (1% O2 ). LPS stimulation further enhanced HIF1α expression in hDPCs, especially within their nuclei. CONCLUSION: HIF1α promoted mRNA expression of IL1ß and TNFα via NFκB signalling in LPS-stimulated hDPCs, suggesting that HIF1α is involved in the progress of inflammation in dental pulp.

Reproductive isolation between sympatric Anguilla japonica and Anguilla marmorata.

Species-specific restriction fragment length polymorphism in the intron of the androgen receptor gene (ar5) was found in glass to silver-stage individuals of Anguilla japonica (n = 51) and A. marmorata (n = 21). The sequence analysis of 16S rDNA from 328 anguillid leptocephali collected in the North Equatorial Current of the western North Pacific Ocean revealed the specimens to be A. japonica (n = 194), A. marmorata (n = 128), A. bicolor pacifica (n = 5) and A. luzonensis (n = 1). All leptocephali of A. japonica and A. marmorata were monomorphic and did not share an allele at the ar5 locus, indicating that the two species are reproductively isolated.

Cross-cultural comparison of breast cancer patients' Quality of Life in the Netherlands and Japan.

PURPOSE: Cultural differences are hypothesized to influence patients' Quality of Life (QoL) reports. However, there is a lack of empirical cross-cultural studies comparing QoL of patients with cancer. This study aims to compare QoL of women with breast cancer in the Netherlands and Japan, and to investigate the association of QoL with sociodemographic, clinical, and psychological variables (illness perceptions). METHODS: Dutch (n = 116) and Japanese (n = 148) women with early breast cancer undergoing chemotherapy completed the EORTC QLQ-C30 and Brief Illness Perception Questionnaire immediately before their second cycle of chemotherapy. RESULTS: Dutch women reported poorer Physical, Role, Emotional, and Cognitive functioning than Japanese women. Additionally, illness perceptions were significantly different in Japan and the Netherlands, but these did not vary across treatment type. In Japan, QoL of women receiving AC-chemotherapy was better than that of women receiving FEC-chemotherapy, whereas in the Netherlands, QoL did not vary as a function of chemotherapy. Illness perceptions about symptom severity, adverse consequences, and emotional representations were negatively related to most domains of patients' QoL in both countries. Adding illness perceptions as covariates to the ANOVA analyses rendered the effects of country and treatment type on QoL non-significant. CONCLUSIONS: Comparing Dutch and Japanese women with early breast cancer revealed important differences in treatment modalities and illness perceptions which both appear to influence QoL. Perceptions about cancer have been found to vary across cultures, and our study suggests that these perceptions should be considered when performing cross-cultural studies focusing on patient-reported outcomes.

Gonadotropin levels in urine during early postnatal period in small for gestational age preterm male infants with fetal growth restriction.

OBJECTIVE: The objective of this study was to estimate gonadotropin concentrations in small for gestational age (SGA) male infants with the reactivation of the hypothalamic-pituitary-gonadal axis during the first few months of life that is important for genital development. STUDY DESIGN: We prospectively examined 15 SGA and 15 appropriate for gestational age (AGA) preterm male infants between 2013 and 2014 at Kyoto University Hospital. Gonadotropin concentrations (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)) were measured in serial urine samples from the postnatal days 7 to 168 and compared between SGA and AGA infants using the Mann-Whitney test. RESULTS: A longitudinal analysis showed that SGA infants had higher LH and lower FSH concentrations (P=0.004 and P=0.006, respectively) than AGA infants. CONCLUSION: Male infants who are SGA at birth because of fetal growth restriction have gonadotropin secretion abnormalities in the first few months of life.

Function of Platelet-Induced Epithelial Attachment at Titanium Surfaces Inhibits Microbial Colonization.

The aim of this study was to evaluate the barrier function of platelet-induced epithelial sheets on titanium surfaces. The lack of functional peri-implant epithelial sealing with basal lamina (BL) attachment at the interface of the implant and the adjacent epithelium allows for bacterial invasion, which may lead to peri-implantitis. Although various approaches have been reported to combat bacterial infection by surface modifications to titanium, none of these have been successful in a clinical application. In our previous study, surface modification with protease-activated receptor 4-activating peptide (PAR4-AP), which induced platelet activation and aggregation, was successful in demonstrating epithelial attachment via BL and epithelial sheet formation on the titanium surface. We hypothesized that the platelet-induced epithelial sheet on PAR4-AP-modified titanium surfaces would reduce bacterial attachment, penetration, and invasion. Titanium surface was modified with PAR4-AP and incubated with platelet-rich plasma (PRP). The aggregated platelets released collagen IV, a critical BL component, onto the PAR4-AP-modified titanium surface. Then, human gingival epithelial cells were seeded on the modified titanium surface and formed epithelial sheets. Green fluorescent protein (GFP)-expressing Escherichia coli was cultured onto PAR4-AP-modified titanium with and without epithelial sheet formation. While Escherichia coli accumulated densely onto the PAR4-AP titanium lacking epithelial sheet, few Escherichia coli were observed on the epithelial sheet on the PAR4-AP surface. No bacterial invasion into the interface of the epithelial sheet and the titanium surface was observed. These in vitro results indicate the efficacy of a platelet-induced epithelial barrier that functions to prevent bacterial attachment, penetration, and invasion on PAR4-AP-modified titanium.

Portal Vein Inflow From Enlarged Coronary Vein in Liver Transplantation: Surgical Approach and Technical Tips: A Case Report.

Portal vein thrombosis is common in patients with end-stage liver disease, with an incidence as high as 26% in liver transplant candidates. It is known to be associated with a high risk of morbidity and mortality posttransplantation, and its management can be challenging. The management options range from a simple thrombendvenectomy to multivisceral transplantation in cases with diffuse portomesenteric thrombosis. We report a case of liver transplantation in which we performed a rare reconstruction of the portal vein. Briefly, the patient had diffuse portomesenteric thrombosis, calcified aneurysmosis, and a large collateral coronary vein, to which we directly anastomosed the donor portal vein in an end-to-side fashion. This report describes a unique surgical approach for similar cases of severe portal vein thrombosis in liver transplant candidates.

Effects of Cosmetic Therapy on Cognitive Function in Elderly Women Evaluated by Time-Resolved Spectroscopy Study.

With the rapid increase in dementia in developed countries, it is important to establish methods for maintaining or improving cognitive function in elderly people. To resolve such problems, we have been developing a cosmetic therapy (CT) program for elderly women. However, the mechanism and limitations of CT are not yet clear. In order to clarify these issues, we employed time-resolved spectroscopy (TRS) to evaluate the effect of CT on prefrontal cortex (PFC) activity in elderly females with various levels of cognitive impairment. Based on the Mini-Mental State Examination (MMSE) score, the subjects were classified into mild (mean MMSE score: 24.1±3.8) and moderate (mean MMSE score: 10.3±5.8) cognitive impairment (CI) groups (p<0.0001). The mild CI group exhibited significantly larger baseline concentrations of oxy-Hb and t-Hb than the moderate CI group. CT significantly increased the baseline concentrations of oxy-Hb (p<0.002) and t-Hb (p<0.0013) in the left PFC in the mild CI group. In contrast, CT did not change the concentrations of oxy-Hb and t-Hb in the moderate CI group (p>0.05). These results suggest that CT affects cognitive function by altering PFC activity in elderly women with mild CI, but not moderate CI.

Allograft Pancreatectomy: Indications and Outcomes.

This study evaluated the indications, surgical techniques, and outcomes of allograft pancreatectomy based on a single center experience. Between 2003 and 2013, 47 patients developed pancreas allograft failure, excluding mortality with a functioning pancreas allograft. Early graft loss (within 14 days) occurred in 16, and late graft loss in 31. All patients with early graft loss eventually required allograft pancreatectomy. Nineteen of 31 patients (61%) with late graft loss underwent allograft pancreatectomy. The main indication for early allograft pancreatectomy included vascular thrombosis with or without severe pancreatitis, whereas one recipient required urgent allograft pancreatectomy for gastrointestinal hemorrhage secondary to an arterioenteric fistula. In cases of late allograft pancreatectomy, graft failure with clinical symptoms such as abdominal discomfort, pain, and nausea were the main indications (13/19 [68%]), simultaneous retransplantation without clinical symptoms in 3 (16%), and vascular catastrophes including pseudoaneurysm and enteric arterial fistula in 3 (16%). Postoperative morbidity included one case each of pulmonary embolism leading to mortality, formation of pseudoaneurysm requiring placement of covered stent, and postoperative bleeding requiring relaparotomy eventually leading to femoro-femoral bypass surgery 2 years after allograftectomy. Allograft pancreatectomy can be performed safely, does not preclude subsequent retransplantation, and may be lifesaving in certain instances.

Genetic testing for spinocerebellar ataxias in patients diagnosed as Parkinson's disease in Bangladesh.

This study was conducted to find out Spinocerebellar Ataxias (SCA) by genetic analysis from those patients presenting with Parkinsonism in the Neurology department of Mymensingh Medical College Hospital, Bangladesh. A sample of about 5ml blood was collected by venipuncture in EDTA tube after having informed consent from each patients and healthy individual, with due Institutional Ethical committee approval for genetic study of 7 healthy people and 9 patients. The neurological disorder along with a complete physical and/or psychological, as well as family history and demographic data was recorded with a prescribed questionnaire by the neurologists of Mymensingh Medical College Hospital. Extraction of genomic DNA from the venous blood using Flexi Gene DNA kit (Qiagen, Japan) was performed in Faculty of Veterinary Science, Bangladesh Agricultural University, Mymensingh, Bangladesh. The extracted DNA was stored, accumulated and then were sent to Division of Clinical Genetics, Department of Medical Genetics, Osaka University Medical School, Suita, Osaka 565 0871, Japan for PCR and further analysis. PCR amplification of the CAG repeat was performed for the SCA1, SCA2, SCA3, SCA6 loci using primers SCA1N-F1 and SCA1N-R1, SCA2-F1 and SCA2-R1, MJDF1 and MJDR1, SCA6-F1 and SCA6-R1, respectively. SCA1 PCR of both healthy individual and suspected Parkinsons Disease (PD) patients DNA was found 250 bp (no. of CAG repeats=36). SCA2 PCR products reveal the DNA products of about 150 bp (no. of CAG repeats=23) except one patient that was suspected and it was sequenced and revealed 175bp (no. of CAG repeats=30). SCA3 PCR product size of both healthy individual and patient DNA was within 250 (no. of CAG repeats=11) to 300 bp (no. of CAG repeats=28) except one patient which was about 320 bp and its CAG repeats was about 34. SCA6 PCR product size of both healthy individual and patient DNA was about 150 bp (no. of CAG repeats=16).

A toll-like receptor 3 single nucleotide polymorphism in Japanese patients with sarcoidosis.

Toll-like receptor 3 (TLR3) may be associated with T helper 1 immune response. This study aimed to investigate the role of a functional TLR3 single nucleotide polymorphism (SNP) in sarcoidosis. We genotyped 220 Japanese patients with sarcoidosis and 140 controls for TLR3 SNP rs3775291 to analyze its association with susceptibility to sarcoidosis and assessed its relationship to clinical features in 172 patients over 2 years. The TLR3 rs3775291 genotype was not significantly associated with disease susceptibility. However, patients with cardiac sarcoidosis (CS) significantly more frequently had the TT genotype (p < 0.01) or the T allele (p < 0.05) than those patients without CS. We conclude that TLR3 SNP rs3775291 may affect cardiac involvement in Japanese patients with sarcoidosis.

Survival of HER2-positive primary breast cancer patients treated by neoadjuvant chemotherapy plus trastuzumab: a multicenter retrospective observational study (JBCRG-C03 study).

We investigated the disease-free survival (DFS) of HER2-positive primary breast cancer patients treated with neoadjuvant chemotherapy plus trastuzumab, as well as predictive factors for DFS and pathologic response. Data from 829 female patients treated between 2001 and 2010 were collected from 38 institutions in Japan. Predictive factors were evaluated using multivariate analyses. The 3-year DFS rate was 87 % [95 % confidence interval (CI) 85-90]. The pathologic complete response (pCR: ypT0/is + ypN0) rate was 51 %. The pCR rate was higher in the ER/PgR-negative patients than in the ER/PgR-positive patients (64 vs. 36 %, P < 0.001). Patients with pCR showed a higher DFS rate than patients without pCR (93 vs. 82 %, P < 0.001). Multivariate analysis revealed three independent predictors for poorer DFS: advanced nodal stage [hazard ratio (HR) 2.63, 95 % CI 1.36-5.21, P = 0.004 for cN2-3 vs. cN0], histological/nuclear grade 3 (HR 1.81, 95 % CI 1.15-2.91, P = 0.011), and non-pCR (HR 1.98, 95 % CI 1.22-3.24, P = 0.005). In the ER/PgR-negative dataset, non-pCR (HR 2.63, 95 % CI 1.43-4.90, P = 0.002) and clinical tumor stage (HR 2.20, 95 % CI 1.16-4.20, P = 0.017 for cT3-4 vs. cT1-2) were independent predictors for DFS, and in the ER/PgR-positive dataset, histological grade of 3 (HR 3.09, 95 % CI 1.48-6.62, P = 0.003), clinical nodal stage (HR 4.26, 95 % CI 1.53-13.14, P = 0.005 for cN2-3 vs. cN0), and young age (HR 2.40, 95 % CI 1.12-4.94, P = 0.026 for ≤40 vs. >40) were negative predictors for DFS. Strict pCR (ypT0 + ypN0) was an independent predictor for DFS in both the ER/PgR-negative and -positive datasets (HR 2.66, 95 % CI 1.31-5.97, P = 0.006 and HR 3.86, 95 % CI 1.13-24.21, P = 0.029, respectively). These results may help assure a more accurate prognosis and personalized treatment for HER2-positive breast cancer patients.

A CD40 single-nucleotide polymorphism affects the lymphocyte profiles in the bronchoalveolar lavage of Japanese patients with sarcoidosis.

CD40 plays a critical role in adaptive immunity, and alveolar macrophages in patients with sarcoidosis express higher levels of CD40. This study investigated the association of rs1883832, a functional single-nucleotide polymorphism in the CD40 gene with susceptibility to sarcoidosis and phenotypes of sarcoidosis. Genotyping of rs1883832 in 175 Japanese patients with sarcoidosis and 150 age- and sex-matched controls revealed no significant difference between the genotypes of the patient and control groups (CC/CT/TT, 32.8/52.0/14.7% in the patients; 37.3/48.0/14.7% in the controls, P = 0.66; allele C, 59.1% in the patients, 61.3% in the controls, P = 0.57). T-cell and CD4+ cell counts in the bronchoalveolar lavage fluid were significantly higher in the TT genotype group than in the CC and CT genotype group.

Defining the clinical outcome status (COS) in sarcoidosis: results of WASOG Task Force.

The clinical outcome of sarcoidosis is quite variable. Several scoring systems have been used to assess the level of disease and clinical outcome. The definition of clinical phenotypes has become an important goal as genetic studies have identified distinct genotypes associated with different clinical phenotypes. In addition, treatment strategies have been developed for patients with resolving versus non resolving disease. A task force was established by the World Association of Sarcoidosis and Other Granulomatous diseases (WASOG) to define clinical phenotypes of the disease based on the clinical outcome status (COS). The committee chose to examine patients five years after diagnosis to determine the COS. Several features of the disease were incorporated into the final nine categories of the disease. These included the current or past need for systemic therapy, the resolution of the disease, and current status of the condition. Sarcoidosis patients who were African American or older were likely to have a higher COS, indicating more chronic disease. The COS may be useful in future studies of sarcoidosis.

Measurement of z-direction component of electron spins field-emitted from a single-crystal magnetite whisker.

A 90° sector type spin rotator was developed for measurement of the z-direction component of a spin polarization, which is parallel to the emitter axis. The rotator enables us to measure all components of electron spins field-emitted from a single crystalline magnetite. In-plane component of spin polarization dominated of field-emitted electrons from single crystalline magnetite whisker, thus it is suggested that the magnetization of the magnetite whisker results from the anisotropy of crystalline structure rather than its shape.

Nutritional predictors of postoperative outcome in pancreatic cancer.

BACKGROUND: Nutritional status plays an important role in the incidence of postoperative complications and the prognosis of various tumours. The prognostic value of preoperative nutritional factors in patients with pancreatic cancer is not known. METHODS: This retrospective study included 268 patients who underwent resection for adenocarcinoma of the pancreas. The predictive value of preoperative nutritional status for postoperative outcome (survival, complications) was assessed. Nutritional factors included the three constitutional indices, serum albumin and Onodera's prognostic nutrition index (PNI), calculated as 10 × serum albumin (g/dl) + 0·005× total lymphocyte count (per mm(3)). RESULTS: In multivariable analysis preoperative low PNI (but not low albumin) was an independent prognostic factor for poor survival: hazard ratio (HR) 1·73 (95 per cent confidence interval (c.i.) 1·21 to 2·47). The accuracy of a PNI value of less than 45 as cut-off for clinically significant preoperative malnutrition in predicting 1- or 2-year survival after surgery was, however, limited (66·4 and 56·3 per cent respectively). Low preoperative albumin concentration and PNI were significantly associated with postoperative complications: odds ratio 1·98 (95 per cent c.i. 1·18 to 3·32) and 2·14 (1·23 to 3·73) respectively. Low PNI and low body mass index were independently associated with pancreatic fistula: HR 2·52 (1·37 to 4·63) and 0·40 (0·17 to 0·93) respectively. CONCLUSION: The PNI is associated with overall survival and postoperative complications, in particular pancreatic fistula, in patients with pancreatic cancer. The moderate accuracy of PNI as a predictor of survival limits its clinical use.

Significance of plasma NT-proBNP levels as a biomarker in the assessment of cardiac involvement and pulmonary hypertension in patients with sarcoidosis.

BACKGROUND: Cardiac involvement and pulmonary hypertension (PH) are life-threatening complications in sarcoidosis. OBJECTIVE: This study aimed to investigate the utility of plasma NT-proBNP in the assessment of these conditions in sarcoidosis patients. STUDY DESIGN AND METHODS: A prospective, observational study was performed on 150 consecutive Japanese sarcoidosis patients. Doppler echocardiography was performed in all subjects, and those who were successfully evaluated for PH status were included in the analysis. Cardiac sarcoidosis was diagnosed based on Japanese guidelines, and PH was defined as estimated systolic pulmonary artery pressure (sPAP) > or = 35 mmHg. The diagnostic accuracy of NT-proBNP according to the presence of cardiac sarcoidosis and PH was assessed based on receiver-operator characteristic (ROC) curves. RESULTS: 130 subjects were successfully evaluated for PH status. Of these, 29 met the diagnostic criteria of cardiac sarcoidosis, and 21 were diagnosed with PH. Plasma NT-proBNP levels were significantly higher in patients with cardiac sarcoidosis (p < 0.0001). Stepwise regression analysis showed that presence of cardiac sarcoidosis, decreased ejection fraction and increased sPAP were all independently associated with higher plasma NT-proBNP levels. Plasma NT-proBNP showed good accuracy in identifying patients with cardiac sarcoidosis (area under the ROC curve; AURC = 0.913). However, even when patients with cardiac sarcoidosis were excluded, plasma NT-proBNP levels could not be used reliably to identify patients with PH (AURC = 0.681). CONCLUSION: In patients with sarcoidosis, plasma NT-proBNP levels are a useful biomarker to identify cardiac involvement, but not to identify PH.

Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial.

AIM: The aim of this study was to examine the effectiveness of earlier continuous Kangaroo Mother Care (KMC) for relatively stable low-birth-weight (LBW) infants in a resource-limited country. METHODS: A randomized controlled trial was performed in LBW infants at a referral hospital in Madagascar. Earlier continuous KMC (intervention) was begun as soon as possible, within 24 h postbirth, and later continuous KMC (control: conventional care) was begun after complete stabilization (generally after 24 h postbirth). Main outcome measure was mortality during the first 28 days postbirth. This trial was registered with ClinicalTrials.gov, NCT00531492. RESULTS: A total of 73 infants (intervention 37, control 36) were included. Earlier continuous KMC had higher but no statistically different mortality in the first 28 days postbirth (1 vs. 2; risk ratio, 1.95; 95% CIs, 0.18-20.53; p = 1.00). There were no differences in incidence of morbidities. Body weight loss from birth to 24 h postbirth was significantly less in earlier KMC infants compared with later KMC infants. (-34.81 g vs. -73.97 g; mean difference, 39.16 g; 95% CIs, 10.30-68.03; p = 0.01; adjusted p = 0.02). Adverse events and duration of hospitalization were not different between the two groups. CONCLUSION: Further evaluations of earlier continuous KMC including measurement of KMC dose, are needed in resource-limited countries.