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BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain. METHODS: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life. RESULTS: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care. CONCLUSIONS: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).
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Incubadoras para Lactentes , Recém-Nascido de Baixo Peso , Método Canguru , África Subsaariana , Aleitamento Materno , Países em Desenvolvimento , Feminino , Humanos , Índia , Lactente , Mortalidade Infantil , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Masculino , Fatores de TempoRESUMO
Leiomyomas are the most common benign tumours of oesophageal smooth muscle origin. In this era of constantly evolving medical technology, video-assisted, robot-assisted and endoscopic approaches are the minimally invasive strategies for the excision of these lesions. Here, we report our modification of this surgery. The lesion was excised with uniportal video-assisted thoracoscopic surgery in a semi-prone position with single-lumen endobronchial intubation.
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Bochdalek hernia (BH) in an adult may manifest clinically with a myriad of abdominal or chest symptoms or a combination of them. Diagnosis of an adult BH is usually delayed in view of rarity of the lesion and its varied presentation. A 30-year-old adult gentleman presented to us with a left thoracostomy which was draining pus and ingested food particles. The tube thoracostomy had been performed in another hospital for an apparent left hydropneumothorax before he arrived in our hospital. Computed tomography of Chest and abdomen revealed a left diaphragmatic defect with herniation of stomach, spleen and omentum into the chest with organo-axial volvulus of the stomach. A thoracostomy tube was seen to be traversing through the stomach with its tip located close to the left pulmonary artery. The patient underwent left thoraco-abdominal exploration with dissection and reposition of the hernial contents in the abdominal cavity. The gastric perforations and the diaphragmatic defect were repaired. This case reiterates a well-known fact that an adult type BH must find a place in the differential diagnosis of a hydropneumothorax. Though the adult BH is a rare diagnosis, unawareness or reluctance to consider the possibility of adult BH may prolong the suffering of the patient as it happened in our patient who had iatrogenic perforation of the stomach due to tube thoracostomy.
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Hérnias Diafragmáticas Congênitas/diagnóstico por imagem , Hérnias Diafragmáticas Congênitas/cirurgia , Volvo Gástrico/diagnóstico por imagem , Volvo Gástrico/cirurgia , Adulto , Diagnóstico Diferencial , Erros de Diagnóstico , Humanos , Hidropneumotórax/diagnóstico , Hidropneumotórax/cirurgia , Masculino , Toracostomia , Tomografia Computadorizada por Raios XRESUMO
Aim: The aim of the study is to compare the clinical efficacy of both the topical agents-aloe vera gel and Kenacort oral paste (0.1% triamcinolone acetonide) in patients with minor aphthous stomatitis. Materials and Methods: 60 patients were recruited for the study and were randomly divided into two groups-Group A (aloe vera gel group) and Group B (Kenacort oral paste group). The baseline parameters were taken and recorded on the day of the first visit which included ulcer size, pain, and burning sensation. Evaluation of reduction in ulcer size, pain, and burning sensation were made on day 3 and day 7. Results: The results of the present study revealed that both the study groups showed no significant difference in the size of ulcer at day 1, day 3, and day 7 when compared using independent t-test as P > 0.05 at all study intervals. Therefore, both the agents were found to be equally effective against reducing the size of ulcer, pain, and burning sensation. Conclusion: The present study findings demonstrate that topical application of the aloe vera gel was able to decrease the ulcer size, intensity of pain, and burning sensation, thereby accelerating the healing without any side effects. Thus, topical aloe vera could be safe and a better alternative to topical steroid for RAS.
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Objectives: To ascertain whether a link exists between vitamin D insufficiency and early childhood caries or not. Method: From the out patient department (OPD) of the Pedodontics Department at Vyas Dental College, a random sample of 40 kids between the ages of 8 months and 5 years old was chosen. Each kid had blood drawn to check their serum 25(OH) vitamin D levels. All of the data was collated and given the necessary statistical analysis. Result: The case group's mean serum 25(OH) vitamin D level was 10.19 ng/mL (with a standard deviation of 3.46), while the control group's was 20.84 ng/mL (2.54 SD). Conclusion: A significant modifiable risk factor for childhood dental caries is a vitamin D deficiency. Therefore, cavities in teeth can be avoided by giving youngsters vitamin D supplements and avoiding vitamin D insufficiency.
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Lichenoid reactions occur exclusively in people who chew tobacco, areca nut, or both, in raw or any manufactured or processed form. The lesion is described as a lichen-planus-like lesion and is termed as quid-induced lichenoid reaction (QILR). In this cross-sectional study, amongst 935 quid consumers, 82 patients were diagnosed with QILR and it was seen that 65 patients used processed forms of tobacco and areca nut. Thereby, it could be concluded that QILR might occur because of flavors used in processing of tobacco and areca nut.
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Aim: To compare the sealing ability of three different materials when used as postendodontic restoration barriers to coronal microleakage in root-filled teeth. Materials and Methods: In the present study, 60 single-rooted mandibular premolars with single canals were selected. After endodontic treatment was done with protaper files, they were divided into three groups of 20 teeth each, which were restored with Zirconomer (Group I), Hi-Dense (Group II), and Surefil composite (Group III), respectively. After storing in artificial saliva for 10 days, all teeth were then immersed in Rhodamine 6G fluorescent dye. Teeth were then sectioned buccolingually in a longitudinal direction. The coronal microleakage was measured in both halves under a fluorescence microscope and images were taken with a digital camera. Data obtained from the study in the form of scoring as per specific criteria was subjected to statistical analysis. Result: Results of the study showed that the minimum amount of coronal microleakage was seen in Group II restored with Hi-Dense followed by Group III restored with Surefil Composite and the maximum amount of coronal microleakage was seen in Group I restored with Zirconomer. Conclusion: On the basis of the results of the present study, it may be concluded that Hi-Dense showed better coronal sealing ability in access cavities. Surefil composite exhibited coronal microleakage less than Zirconomer but more than Hi-Dense.
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BACKGROUND: Commensal flora constitutes a reservoir of antibiotic resistance. The increasing variety of ß-lactamases and the emergence of Carbapenem resistant Enterobacteriaceae (CRE) in community, raise concerns regarding efficacy of ß-lactams. It is important to know the exact load of antibiotic resistance in the absence of any antibiotic selection pressure including via food and water.In the present study gut colonization in neonates with no direct antibiotic pressure was used as a model to evaluate ß-lactam resistance in the community. RESULTS: In this prospective study, 75 healthy, vaginally delivered, antibiotic naive, breast fed neonates were studied for gut colonization by Extended spectrum ß-lactamases (ESBL), AmpC ß-lactamases hyperproducing Enterobacteriaceae and CRE on day 0, 21 and 60. Total 267 Enterobacteriaceae were isolated and E.coli was the predominant flora. ESBL, AmpC and coproduction was seen in 20.6%, 19.9% and 11.2% isolates respectively. ESBL carriage increased threefold from day 1 to 60 showing predominance of CTX-M group 15 (82.5%), ampC genes were heterogeneous. Colonization with CRE was rare, only one baby harboured Enterobacter sp positive for kpc-2. The reservoirs for these genes are likely to be mother and the environment. CONCLUSIONS: Data strongly suggests that in absence of any antibiotic pressure there is tremendous load of antibiotic resistance to ß-lactam drugs. Wide spread presence of ESBL and AmpC can drive rapid emergence and dissemination of CRE. This is the first report from India which depicts the smaller picture of true antibiotic pressure present in the Indian community.
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Portador Sadio/microbiologia , Infecções Comunitárias Adquiridas/microbiologia , Infecções por Enterobacteriaceae/microbiologia , Enterobacteriaceae/enzimologia , Enterobacteriaceae/isolamento & purificação , Trato Gastrointestinal/microbiologia , beta-Lactamases/metabolismo , Humanos , Índia , Lactente , Recém-Nascido , Estudos Prospectivos , Fatores de TempoRESUMO
Aim: To investigate the safety of skin-to-skin contact initiated immediately after birth on cardiorespiratory parameters in unstable low birth weight infants. Methods: A randomized clinical trial was conducted in tertiary newborn units in Ghana, India, Malawi, Nigeria and Tanzania in 2017-2020, in infants with birth weight 1.0-1.799 kg. The intervention was Kangaroo mother care initiated immediately after birth and continued until discharge compared to conventional care with Kangaroo mother care initiated after meeting stability criteria. The results of the primary study showed that immediate Kangaroo mother care reduced neonatal mortality by 25% and the results have been published previously. The post-hoc outcomes of this study were mean heart rate, respiratory rate, oxygen saturation during the first four days and the need of respiratory support. Results: 1,602 infants were allocated to control and 1,609 to intervention. Mean birth weight was 1.5 kg (SD 0.2) and mean gestational age was 32.6 weeks (SD 2.9). Infants in the control group had a mean heart rate 1.4 beats per minute higher (95% CI -0.3-3.1, p = 0.097), a mean respiratory rate 0.4 breaths per minute higher (-0.7-1.5, p = 0.48) and a mean oxygen saturation 0.3% higher (95% CI -0.1-0.7, p = 0.14) than infants in the intervention group. Conclusion: There were no significant differences in cardiorespiratory parameters during the first four postnatal days. Skin-to-skin contact starting immediately after birth is safe in low birth weight infants in limited-resource settings.
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Background: To implement the immediate Kangaroo mother care (iKMC) intervention in the previous multicentre, open-label, randomised controlled trial, the mother or a surrogate caregiver and neonate needed to be together continuously, which led to the concept of the Mother-Newborn Care Unit (MNCU). Health-care providers and administrators were concerned of the potential increase in infections caused by the continuous presence of mothers or surrogates in the MNCU. We aimed to assess the incidence of neonatal sepsis in sub-groups and the bacterial profile among intervention and control neonates in the study population. Methods: This is a post-hoc analysis of the previous iKMC trial, which was conducted in five level 2 Newborn Intensive Care Units (NICUs) one each in Ghana, India, Malawi, Nigeria, and Tanzania, in neonates with birth weight 1 to <1.8 kg. The intervention was KMC initiated immediately after birth and continued until discharge and compared to conventional care with KMC initiated after meeting stability criteria. The primary outcomes of this report were the incidence of neonatal sepsis in sub-groups, sepsis-related mortality and bacterial profile of isolates during hospital stay. The original trial is registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12618001880235) and the Clinical Trials Registry-India (CTRI/2018/08/01536). Findings: Between November 30, 2017, and January 20, 2020, 1609 newborns in the intervention group and in the control group 1602 newborns were enrolled in iKMC study. 1575 newborns in the intervention group and 1561 in the control group were clinically evaluated for sepsis. Suspected sepsis was 14% lower in intervention group in sub-group of neonates with birth weight 1.0-<1.5 kg; RR 0.86 (CI 0.75, 0.99). Among neonates with birth weight 1.5-<1.8 kg, suspected sepsis was reduced by 24%; RR 0.76 (CI 0.62, 0.93). Suspected sepsis rates were lower in intervention group than in the control group across all sites. Sepsis related mortality was 37% less in intervention group than the control group; RR 0.63 (CI 0.47-0.85) which was statistically significant. The intervention group had fewer cases of Gram-negative isolates (n = 9) than Gram positive isolates (n = 16). The control group had more cases of Gram-negative isolates (n = 18) than Gram positive (n = 12). Interpretation: Immediate Kangaroo Mother care is an effective intervention to prevent neonatal sepsis and sepsis related mortality. Funding: The original trial was funded by the Bill and Melinda Gates Foundation through a grant to the World Health Organization (grant No. OPP1151718).
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INTRODUCTION: It is unclear if serum procalcitonin (PCT) estimated at sepsis suspicion can help detect culture-positive sepsis in neonates. We evaluated the diagnostic performance of PCT in culture-positive sepsis in neonates. METHODS: This was a prospective study (February 2016 to September 2020) conducted in four level-3 units in India. We enrolled neonates suspected of sepsis in the first 28 days of life. Neonates with birth weight <750 g, asphyxia, shock, and major malformations were excluded. Blood for PCT assay was drawn along with the blood culture at the time of suspicion of sepsis and before antibiotic initiation. The investigators labeled the neonates as having culture-positive sepsis or "no sepsis" based on the culture reports and clinical course. PCT assay was performed by electrochemiluminescence immunoassay, and the clinicians were masked to the PCT levels while assigning the label of sepsis. Primary outcomes were the sensitivity, specificity, and likelihood ratios to identify culture-positive sepsis. RESULTS: The mean birth weight (SD) and median gestation (IQR) were 2,113 (727) g and 36 (32-38) weeks, respectively. Of the 1,204 neonates with eligible cultures, 155 (12.9%) had culture-positive sepsis. Most (79.4%) were culture-positive within 72 h of birth. The sensitivity, specificity, and positive and negative likelihood ratios at 2 ng/mL PCT threshold were 52.3% (95% confidence interval: 44.1-60.3), 64.5% (60.7-68.1), 1.47 (1.23-1.76), and 0.74 (0.62-0.88), respectively. Adding PCT to assessing neonates with 12.9% pretest probability of sepsis generated posttest probabilities of 18% and 10% for positive and negative test results, respectively. CONCLUSION: Serum PCT did not reliably identify culture-positive sepsis in neonates.
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Pró-Calcitonina , Sepse , Recém-Nascido , Humanos , Estudos Prospectivos , Calcitonina , Peptídeo Relacionado com Gene de Calcitonina , Peso ao Nascer , Biomarcadores , Sensibilidade e Especificidade , Precursores de Proteínas , Sepse/diagnóstico , Proteína C-Reativa/análiseRESUMO
While a Cochrane review (2016) showed that kangaroo mother care (KMC) initiated after clinical stabilization reduces mortality by 40%, evidence of the effect of initiating KMC immediately after birth without waiting for babies to become stable was unavailable until recently. This research gap was addressed by a multicountry, randomized, controlled trial co-ordinated by WHO. This trial was conducted in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania. Implementation of this trial led to development of the "mother-newborn care unit (MNCU)." Mother-newborn care unit or mother-newborn intensive care unit (M-NICU) is a facility where sick and small newborns are cared with their mothers 24 × 7 with all facilities of level II newborn care and provision for postnatal care to mothers. The mother is not a mere visitor, but she has her bed inside the special newborn care unit (SNCU)/newborn intensive care unit (NICU) and as a resident of MNCU, becomes an active caregiver and is involved in continuum of neonatal care. The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU. World Health Organization is in the process of reviewing the current recommendations on care of preterm or LBW newborns considering new evidence that has become available. However, it would require national policy change to permit mother and surrogate in SNCU/NICU 24 × 7, making the concept of zero-separation a reality.
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Método Canguru , Mães , Criança , Feminino , Humanos , Índia , Recém-Nascido de Baixo Peso , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Método Canguru/métodos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Objective The aim was to find the prevalence of colonization of vagina with aerobic bacteria among low-risk Indian women in active labor and its association with early-onset neonatal sepsis (EONS) and puerperal sepsis. Methods The study was conducted prospectively from October 2018 to March 2020 in a tertiary hospital in New Delhi, India. Low-risk pregnant women (N=920) in active labor with intact membranes were recruited. High vaginal swabs were collected, cultured by standard methods to detect aerobic bacteria. The primary outcomes were the development of puerperal sepsis and EONS. Results In a total of 920 low-risk subjects, vaginal colonization was found in 484 (52.6%), coagulase-negative Staphylococcus being the predominant colonizer (13.2%) followed by Escherichia coli (8.9%). Multigravida women were at 1.4 times higher risk of colonization than primigravida (odds ratio [OR] 1.399; 95% CI 1.064, 1.84). Women whose sample was collected at the first vaginal examination were at 0.34 times lower risk of colonization as compared to women with more than one vaginal examination (OR 0.34; 95% CI 0.241, 0.481). The incidence of colonization increased with progressive vaginal examinations (p<0.001). None of the colonized women and their neonates developed puerperal sepsis or EONS, respectively. Conclusion Vaginal colonization of aerobic bacteria in active labor is not associated with an increased risk of puerperal sepsis or EONS.
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Chikungunya virus is an RNA virus that belongs to the family Togaviridae, genus Alphavirus, transmitted by Aedes mosquitoes. The disease usually manifests as fever, arthralgia and petechial or maculopapular rash. The illness is usually self-limiting. We report a series of neonates infected with Chikungunya virus, confirmed by ELISA test, showing that viral Chikungunya can be transmitted from mother to babies and its clinical presentation is that of septicemia or meningitis.
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Febre de Chikungunya/transmissão , Transmissão Vertical de Doenças Infecciosas , Complicações Infecciosas na Gravidez/virologia , Animais , Febre de Chikungunya/diagnóstico , Vírus Chikungunya/isolamento & purificação , Feminino , Humanos , Recém-Nascido , Masculino , GravidezRESUMO
BACKGROUND: Neonatal sepsis is a major cause of death in India, which needs hospital management but many families cannot access hospitals. The World Health Organization and the Government of India developed a guideline to manage possible serious bacterial infection (PSBI) when a referral is not feasible. We implemented this guideline to achieve high coverage of treatment of PSBI with low mortality. METHODOLOGY: The implementation research study was conducted in over 50 villages of Palwal district, Haryana during August 2017-March 2019 and covered a population of 199143. Policy dialogue with central, state and district health authorities was held before initiation of the study. A baseline assessment of the barriers in the implementation of the PSBI intervention was conducted. The intervention was implemented in the program setting. The research team collected data throughout and also co-participated in the implementation of the intervention for the first six months to identify bottlenecks in the health system and at the community level. RE-AIM framework was utilized to document implementation strategies of PSBI management guideline. Implementation strategies by the district technical support unit (TSU) included: (i) empower mothers and families through social mobilization to improve care-seeking of sick young infants 0-59 days of age, (ii) build capacity through training and build confidence through technical support of health staff at primary health centers (PHC), community health centers (CHC) and sub-centers to manage young infants with PSBI signs and (iii) improve performance of accredited social health activists (ASHAs). FINDINGS: A total of 370 young infants with signs of PSBI were identified and managed in 5270 live births. Treatment coverage was 70% assuming that 10% of live births would have PSBI within the first two months of life. Mothers identified 87.6% (324/370) of PSBI cases. PHCs and CHCs became functional and managed 150 (40%) sick young infants with PSBI. Twenty four young infants (7-59days) who had only fast breathing were treated with oral amoxicillin without a referral. Referral to a hospital was refused by 126 (84%); 119 had clinical severe infection (CSI), one 0-6 days old had fast breathing and six had critical illness (CI). Of 119 CSI cases managed on outpatient injection gentamicin and oral amoxicillin, 116 (96.7%) recovered, 55 (45.8%) received all seven gentamicin injections and only one died. All 7-59 day old infants with fast breathing recovered, 23 on outpatient oral amoxicillin treatment; and 19 (79%) received all doses. Of 65 infants managed at either district or tertiary hospital, two (3.1%) died, rest recovered. Private providers managed 155 (41.9%) PSBI cases, all except one recovered, but sub-classification and treatment were unknown. Sub-centers could not be activated to manage PSBI. CONCLUSION: The study demonstrated resolution of implementation bottlenecks with existing resources, activated PHCs and CHCs to manage CSI and fast breathers (7-59 day old) on an outpatient basis with low mortality when a referral was not feasible. TSU was instrumental in these achievements. We established the effectiveness of oral amoxicillin alone in 7-59 days old fast breathers and recommend a review of the current national policy.
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Infecções Bacterianas/tratamento farmacológico , Encaminhamento e Consulta , Assistência Ambulatorial , Amoxicilina/uso terapêutico , Antibacterianos/uso terapêutico , Gentamicinas/uso terapêutico , Humanos , Índia , Lactente , Mortalidade Infantil , Recém-Nascido , Aceitação pelo Paciente de Cuidados de SaúdeRESUMO
INTRODUCTION: The COVID-19 pandemic is disrupting health systems globally. Maternity care disruptions have been surveyed, but not those related to vulnerable small newborns. We aimed to survey reported disruptions to small and sick newborn care worldwide and undertake thematic analysis of healthcare providers' experiences and proposed mitigation strategies. METHODS: Using a widely disseminated online survey in three languages, we reached out to neonatal healthcare providers. We collected data on COVID-19 preparedness, effects on health personnel and on newborn care services, including kangaroo mother care (KMC), as well as disruptors and solutions. RESULTS: We analysed 1120 responses from 62 countries, mainly low and middle-income countries (LMICs). Preparedness for COVID-19 was suboptimal in terms of guidelines and availability of personal protective equipment. One-third reported routine testing of all pregnant women, but 13% had no testing capacity at all. More than 85% of health personnel feared for their own health and 89% had increased stress. Newborn care practices were disrupted both due to reduced care-seeking and a compromised workforce. More than half reported that evidence-based interventions such as KMC were discontinued or discouraged. Separation of the mother-baby dyad was reported for both COVID-positive mothers (50%) and those with unknown status (16%). Follow-up care was disrupted primarily due to families' fear of visiting hospitals (~73%). CONCLUSION: Newborn care providers are stressed and there is lack clarity and guidelines regarding care of small newborns during the pandemic. There is an urgent need to protect life-saving interventions, such as KMC, threatened by the pandemic, and to be ready to recover and build back better.
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COVID-19/prevenção & controle , Pessoal de Saúde/estatística & dados numéricos , Cuidado do Lactente , Aleitamento Materno , Estudos Transversais , Feminino , Humanos , Cuidado do Lactente/métodos , Cuidado do Lactente/estatística & dados numéricos , Recém-Nascido , Método Canguru , Pandemias , Gravidez , SARS-CoV-2 , Inquéritos e QuestionáriosRESUMO
Cardiac tumors are rare in neonates, most are benign hamartomas (rhabdomyomas) of the muscle cells. Due of large size, they may cause homodynamic instability and even death in neonatal period. They are rarely diagnosed prenatally and are found in multiple forms. In â¼50% of the cases, rhabdomyoma is associated with tuberous sclerosis.
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Neoplasias Cardíacas/complicações , Rabdomioma/complicações , Cardiomegalia/etiologia , Evolução Fatal , Neoplasias Cardíacas/diagnóstico , Humanos , Recém-Nascido , Masculino , Rabdomioma/diagnósticoRESUMO
OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.
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Produtos Biológicos/uso terapêutico , Recém-Nascido Prematuro , Surfactantes Pulmonares/uso terapêutico , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Animais , Área Sob a Curva , Bovinos , Método Duplo-Cego , Feminino , Cabras , Humanos , Recém-Nascido , Recém-Nascido Prematuro/sangue , Masculino , Oxigênio/sangue , Resultado do TratamentoRESUMO
Health facilities in India are faced with the challenge of providing quality newborn care in the face of major skilled human resource shortage. A possible solution is the concept of Mother-Neonatal ICU (M-NICU), where the mother has her bed inside the neonatal intensive care unit (NICU) by the side of baby's warmer. Our observations in M-NICU of a public sector hospital in New Delhi, India, indicate that mothers can be easily trained to follow asepsis routines and monitor the neonates, and are better prepared for their post-discharge care. Incorporating space for both mothers and their newborns in level-II NICUs may provide quality and developmentally supportive newborn care in coming years.