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1.
Heliyon ; 7(1): e05757, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33474505

RESUMO

Background: Studies in low-income countries have shown that among Bacille Calmette-Guérin (BCG) vaccinated children, those who develop a BCG-scar have significantly better survival than those who do not develop a scar. In a Danish multicenter randomized clinical trial we assessed determinants for developing a BCG-scar and for BCG scar size following neonatal BCG vaccination. Methods: At three Danish hospitals, newborns were randomized 1:1 to BCG vaccination or no BCG vaccination. The infants were invited for a clinical examination at the ages of 3 and 13 months. At 13 months, the scar site was inspected and scar size measured. We investigated three groups of determinants; external, parental, and individual-level determinants on relative scar prevalence and differences in median scar sizes. Results: Among 2118 BCG vaccinated infants, 2039 (96 %) were examined at 13 months; 1857 of these (91 %) had developed a BCG-scar. Compared with Copenhagen University Hospital, Hvidovre (85 %), Copenhagen University Hospital, Rigshospitalet had a scar prevalence of 95 % (adjusted Prevalence ratio (aPR) = 1.24 [CI 95 %: 1.18 to 1.30]); it was 93 % at Kolding Hospital (aPR 1.27 [CI 95 %: 1.19 to 1.35]). Increasing vaccine experience was positively associated with developing a scar and with scar size. Conclusion: Across multiple potential determinants of BCG scaring and size, logistical factors dominated. The results support that injection technique is an important determinant of developing a scar. Given the strong link between having a BCG scar and subsequent health, improved BCG vaccination technique could play a major role for child health.

2.
PLoS One ; 15(5): e0231579, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32401753

RESUMO

INTRODUCTION: In pregnancy after Roux-en-Y gastric bypass (RYGB), there is increased risk of low birthweight in the offspring. The present study examined how offspring body composition was affected by RYGB. MATERIAL AND METHODS: Mother-newborn dyads, where the mothers had undergone RYGB were included. Main outcome measure was neonatal body composition. Neonatal body composition was assessed by dual-energy X-ray absorptiometry scanning (DXA) within 48 hours after birth. In a statistical model offspring born after RYGB were compared with a reference material of offspring and analyses were made to estimate the effect of maternal pre-pregnancy body mass index (BMI), gestational weight gain, parity, gestational age at birth and newborn sex on newborn body composition. Analyses were made to estimate the impact of maternal weight loss before pregnancy and of other effects of bariatric surgery respectively. The study was performed at a university hospital between October 2012 and December 2013. RESULTS: We included 25 mother-newborn dyads where the mothers had undergone RYGB and compared them to a reference material of 311 mother-newborn dyads with comparable pre-pregnancy BMI. Offspring born by mothers after RYGB had lower birthweight (335g, p<0.001), fat-free mass (268g, p<0.001) and fat% (2.8%, p<0.001) compared with reference material. Only 2% of the average reduction in newborn fat free mass could be attributed to maternal pre-pregnancy weight loss whereas other effects of RYGB accounted for 98%. Regarding reduction in fat mass 52% was attributed to weight loss and 47% to other effects of surgery. CONCLUSION: Offspring born after maternal bariatric surgery, had lower birthweight, fat-free mass and fat percentage when compared with a reference material. RYGB itself and not the pre-pregnancy weight loss seems to have had the greatest impact on fetal growth.


Assuntos
Cirurgia Bariátrica/efeitos adversos , Peso ao Nascer , Composição Corporal , Recém-Nascido Pequeno para a Idade Gestacional/fisiologia , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/etiologia , Complicações na Gravidez/etiologia , Adulto , Índice de Massa Corporal , Feminino , Desenvolvimento Fetal , Humanos , Recém-Nascido , Masculino , Gravidez
4.
Ugeskr Laeger ; 182(14A)2020 03 30.
Artigo em Dinamarquês | MEDLINE | ID: mdl-32285788

RESUMO

This review gives a summary of Danish preterm care, which has been defined by national adaptation of antenatal corticosteroids in the 1970ies and continuous positive airway pressure in the 1980ies. Today, preterm survival in Denmark is high, by international standards, but lower than in the neighbouring countries Sweden and Norway. The lack of a national neonatal quality database may offer an explanation to this. Starting in 2019, the Danish Newborn Quality Database reports complete population-based measures of newborn survival and health and may help improve standards of care in the future.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Bases de Dados Factuais , Dinamarca/epidemiologia , Feminino , Humanos , Recém-Nascido , Noruega , Gravidez , Suécia/epidemiologia
5.
Acta Paediatr ; 109(10): 2025-2032, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32259301

RESUMO

AIM: Exclusive breastfeeding is recommended for the first 6 months of life, but the breastfeeding rate in premature infants is low. We examined the effect of oral stimulation on infant's strength of suction and the relation between this intra-oral vacuum and breastfeeding duration. METHOD: Between 2016 and 2018, 211 infants in a Danish neonatal unit were randomised 1:1 and of these 108 to oral stimulation intervention and 103 to control. Suction was measured as peak vacuum at enrolment and a corrected age of 6 weeks. Breastfeeding duration was registered. RESULTS: Vacuum increased from enrolment to a corrected age of 6 weeks in all infants, and no effect of oral stimulation intervention was demonstrated P = .08. Infants born ≤32 gestational weeks had lower vacuum compared with infants born after, 350 vs 398 mbar P < .001. For infants born after 32 gestational weeks, the odds ratio for exclusive breastfeeding at 6 months was 1.99 per 100 mbar increase in vacuum P = .01. CONCLUSION: In our study, infant's intra-oral vacuum increased with age and was not affected by the oral stimulation intervention. For infants born after 32 gestational weeks, the exclusive breastfeeding rate was positively associated with a strong vacuum.


Assuntos
Aleitamento Materno , Recém-Nascido Prematuro , Feminino , Humanos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Fatores de Tempo , Vácuo
6.
Vaccine ; 38(11): 2449-2455, 2020 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-32057570

RESUMO

BACKGROUND: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis (TB) may have beneficial non-specific effects (NSEs) beyond the protection against TB. This may be related to modifications of the innate immune system. We investigated the effect of BCG at birth on differential white blood cell (WBC) count in healthy, Danish infants. METHOD: The Danish Calmette Study randomised newborns to BCG at birth (Danish strain 1331, Statens Serum Institut) or no intervention. A sub-group of infants had blood samples collected 4 days after randomisation (n = 161), and at age 3 months (n = 152) and 13 months (n = 300). We evaluated the effect of BCG on WBC differential count (total leucocytes, lymphocytes, monocytes, eosinophil, neutrophil and basophil granulocytes (109 cells/L)) measured in peripheral blood. RESULTS: Overall, we found no effect of BCG on differential WBC counts at any time point. CONCLUSION: BCG at birth did not affect WBC count in our cohort of healthy, Danish infants.


Assuntos
Vacina BCG/administração & dosagem , Contagem de Leucócitos , Tuberculose , Estudos de Coortes , Dinamarca , Humanos , Lactente , Recém-Nascido , Tuberculose/prevenção & controle , Vacinação
7.
Acta Paediatr ; 109(10): 2017-2024, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-31954063

RESUMO

AIM: Although exclusive breastfeeding is recommended for all newborn in the first 6 months of life, only 13% of Danish premature infants complies with this. This trial aimed to examine whether oral stimulation prolonged exclusive breastfeeding in premature infants. METHOD: A randomised controlled trial was conducted at the Neonatal Intensive Care Unit, Hvidovre Hospital, Denmark between 2016 and 2018. Systematic oral stimulation was performed by the parents after training by occupational therapists. Primary outcome was exclusive breastfeeding duration with 6 months' follow-up, analysed by intention-to-treat. RESULTS: Included were 211 infants (53% boys) with a mean gestational age of 231 days, allocated in ratio 1:1 to oral stimulation or standard care. There was no difference in exclusive breastfeeding duration between infants orally stimulated and control infants. Thus, for orally stimulated infants, median duration was 122 days (interquartile range 40-183) in contrast to 154 days (interquartile range 61-183) for the controls, P value .16. At 6 months of age, 27% of orally stimulated infants were exclusively breastfed compared with 25% of controls. CONCLUSION: In healthy premature infants, oral stimulation performed by parents has no long-lasting effect on breastfeeding duration. Attention should be directed to parental education and involvement.


Assuntos
Aleitamento Materno , Doenças do Prematuro , Adulto , Feminino , Humanos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Fatores de Tempo
9.
J Pediatric Infect Dis Soc ; 8(3): 213-220, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-29635419

RESUMO

BACKGROUND: The bacillus Calmette-Guérin (BCG) vaccine against tuberculosis might reduce the non-tuberculosis-related child mortality rate in low-income settings. We tested the hypothesis that BCG vaccination at birth would reduce early childhood hospitalization for infection in Denmark, a high-income setting. Hospitalization for infection was a secondary outcome in a randomized trial with the primary aim to estimate the potential non-specific effects of BCG vaccination at birth on all-cause hospitalization. METHODS: A total of 4262 children included in the Danish Calmette Study were assigned randomly to either receive the BCG vaccine or not and were followed through the Danish National Patient Register. The outcome was number of hospitalizations for infection until the age of 15 months. Data were analyzed by Cox regression in intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: In the ITT analysis, we observed 588 hospitalizations for infection (mean, 0.28 hospitalization per child) among the 2129 children allocated to receive the BCG vaccine and 595 hospitalizations for infection (mean, 0.28 hospitalization per child) among the 2133 children allocated to the control group (hazard ratio [HR], 0.99 [95% confidence interval (CI), 0.85-1.15]). The PP analysis yielded an HR of 1.00 (95% CI, 0.86-1.16).Predefined interaction ITT analyses showed that among 740 children with a BCG-vaccinated mother, the HR for BCG-vaccinated children was 0.65 (95% CI, 0.45-0.94); the HR for children who had a non-BCG-vaccinated mother was 1.10 (95% CI, 0.93-1.29) (P = .01, test of no interaction). Cesarean delivery modified the effect of BCG vaccination (HRs, 0.73 [95% CI, 0.54-0.99] in children born by cesarean section vs 1.10 [95% CI, 0.92-1.30] in other children; P = .02). When the outcome was defined as time to first hospitalization, the HR for premature children after BCG vaccination was 1.81 (95% CI, 0.95-3.43), whereas the HR was 0.94 (95% CI, 0.82-1.08) for children born at term (P = .05). CONCLUSION: BCG vaccination did not affect the rate of hospitalization for infection up to the age of 15 months in Danish children. In future studies, the role of maternal BCG-vaccination, premature birth, and cesarean delivery needs further exploration.


Assuntos
Vacina BCG/administração & dosagem , Hospitalização/estatística & dados numéricos , Vacinação/métodos , Dinamarca , Feminino , Humanos , Programas de Imunização , Lactente , Recém-Nascido , Masculino , Modelos de Riscos Proporcionais , Tuberculose/prevenção & controle
10.
Dan Med J ; 65(9)2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30187858

RESUMO

INTRODUCTION: Due to the design of Hvidovre Hospital, the outpatient clinic of the Department of Paediatrics has windowless consultation rooms. Work environment surveys revealed that nurses and doctors working in these windowless rooms considered the lack of natural light a considerable health problem. This study evaluated the effects of installing light-emitting diode (LED) virtual windows in these rooms. METHODS: Four similar windowless consultations rooms located next to each other were used in the study. All had older T-5 fluorescent luminaires installed. In two of these rooms, Servodan LED virtual windows depicting various natural scenes were installed. The illuminance and correlated colour temperature (CCT) of each room's lighting was measured, and a work environment questionnaire was filled out by nurses and doctors working in each room. RESULTS: A total of 113 questionnaires were collected and evaluated. LED virtual windows produced an improved perception of lighting conditions, both at the desk (p < 0.001) and in the rooms in general (p < 0.001) and improved the overall positive experience of the rooms (p = 0.02). A tendency towards concentration difficulties was reported less often in the rooms with LED virtual windows, (p = 0.11). Retinal illuminance (p = 0.02) as well as CCT at the desk (p < 0.005) and at the retina (p < 0.01) alike were increased in rooms with LED virtual windows. CONCLUSIONS: LED virtual windows improved the lighting experience, the impression of the space, the retinal illuminance and the CCT at the desk and at the retina in the windowless rooms. FUNDING: none. TRIAL REGISTRATION: not relevant.


Assuntos
Arquitetura Hospitalar , Luz , Recursos Humanos em Hospital/psicologia , Feminino , Humanos , Masculino , Inquéritos e Questionários , Local de Trabalho
11.
Sci Rep ; 7(1): 12398, 2017 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-28963455

RESUMO

The Bacillus Calmette-Guérin vaccine (BCG) has been associated with beneficial non-specific effects (NSEs) on infant health. Within a randomized trial on the effect of neonatal BCG on overall health, we investigated the possible immunological impact of neonatal BCG vaccination on lymphocyte subsets, determined by flow cytometry. In 118 infants blood samples were obtained 4 (±2) days post randomization to BCG vaccination or no intervention, and at 3 and 13 months of age. No effects of BCG were found at 4 days. However, BCG increased proportions of effector memory cells at 3 months (Geometric mean ratio (GMR) 1.62, 95% confidence interval (CI) (1.20-2.21), p = 0.002 for CD4+ T cells and GMR 1.69, 95% CI (1.06-2.70), p = 0.03 for CD8+ T cells), and reduced proportions of late differentiated CD4+ T cells (GMR = 0.62, 95% CI (0.38-1.00), p = 0.05) and apoptotic CD4+ T cells at 13 months (GMR = 0.55, 95% CI (0.32-0.92), p = 0.03). In conclusion, limited overall impact of neonatal BCG vaccination on lymphocyte subsets was found in healthy Danish infants within the first 13 months of life. This is in line with the limited clinical effects of BCG observed in our setting.


Assuntos
Subpopulações de Linfócitos B/imunologia , Vacina BCG/imunologia , Subpopulações de Linfócitos T/imunologia , Tuberculose/prevenção & controle , Vacinação , Dinamarca , Humanos , Lactente , Recém-Nascido , Contagem de Linfócitos
12.
BMC Infect Dis ; 17(1): 540, 2017 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-28774269

RESUMO

BACKGROUND: The Bacillus Calmette-Guérin vaccine (BCG) against tuberculosis is administered intradermally, and vaccination is often followed by a scar at the injection site. Among BCG-vaccinated individuals, having a scar has been associated with lower mortality. We aimed to examine the impact of vaccination technique for scarring in a high income setting, by assessing the associations between the post injection reaction, the wheal size, and the probability of developing a scar, and scar size. METHODS: This study was nested within a clinical multicenter study randomizing 4262 infants to either BCG vaccination (BCG 1331 SSI) or no intervention. In this substudy, including 492 vaccinated infants, the immediate post BCG vaccination reaction was registered as either wheal (a raised, blanched papule at the injection site), bulge (a palpable element at the injection site), or no reaction. The presence or absence of a BCG scar and the size the scar was measured at 13 months of age. RESULTS: Of 492 infants included, 87% had a wheal after vaccination, 11% had a bulge, and 2% had no reaction. The mean wheal size was 3.8 mm (95% confidence interval 3.7-3.9). Overall, 95% (442/466, 26 lost to follow-up) of BCG-vaccinated infants had a scar at 13 months of age. In infants with a wheal, the probability of developing a scar was 96%, declining to 87% in the case of a bulge, and to 56% in the case of no reaction (p for same probability = 0.03). Wheal size was positively correlated with the probability of getting a scar and scar size. CONCLUSION: Scarring after BCG vaccination has been associated with lower infant mortality. In a high-income setting, we found that correct injection technique is highly important for the development of a BCG scar and that registration of the category of BCG skin reaction (as wheal, bulge, or no reaction) may be used to identify infants at risk of scar failure. Finally, the wheal size was positively associated with both the probability of getting a scar and scar size. TRIAL REGISTRATION: The study was registered at www.ClinicalTrials.gov with trial registration number NCT01694108 .


Assuntos
Vacina BCG/efeitos adversos , Cicatriz/etiologia , Vacina BCG/administração & dosagem , Bacillus , Dinamarca/epidemiologia , Feminino , Humanos , Lactente , Mortalidade Infantil , Perda de Seguimento , Masculino , Teste Tuberculínico , Vacinação/efeitos adversos , Vacinação/métodos
13.
JAMA Pediatr ; 171(7): 678-686, 2017 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-28505223

RESUMO

Importance: Administration-to-birth intervals of antenatal corticosteroids (ANS) vary. The significance of this variation is unclear. Specifically, to our knowledge, the shortest effective administration-to-birth interval is unknown. Objective: To explore the associations between ANS administration-to-birth interval and survival and morbidity among very preterm infants. Design, Setting, and Participants: The Effective Perinatal Intensive Care in Europe (EPICE) study, a population-based prospective cohort study, gathered data from 19 regions in 11 European countries in 2011 and 2012 on 4594 singleton infants with gestational ages between 24 and 31 weeks, without severe anomalies and unexposed to repeated courses of ANS. Data were analyzed November 2016. Exposure: Time from first injection of ANS to delivery in hours and days. Main Outcomes and Measures: Three outcomes were studied: in-hospital mortality; a composite of mortality or severe neonatal morbidity, defined as an intraventricular hemorrhage grade of 3 or greater, cystic periventricular leukomalacia, surgical necrotizing enterocolitis, or stage 3 or greater retinopathy of prematurity; and severe neonatal brain injury, defined as an intraventricular hemorrhage grade of 3 or greater or cystic periventricular leukomalacia. Results: Of the 4594 infants included in the cohort, 2496 infants (54.3%) were boys, and the mean (SD) gestational age was 28.5 (2.2) weeks and mean (SD) birth weight was 1213 (400) g. Mortality for the 662 infants (14.4%) unexposed to ANS was 20.6% (136 of 661). Administration of ANS was associated with an immediate and rapid decline in mortality, reaching a plateau with more than 50% risk reduction after an administration-to-birth interval of 18 to 36 hours. A similar pattern for timing was seen for the composite mortality or morbidity outcome, whereas a significant risk reduction of severe neonatal brain injury was associated with longer administration-to-birth intervals (greater than 48 hours). For all outcomes, the risk reduction associated with ANS was transient, with increasing mortality and risk for severe neonatal brain injury associated with administration-to-birth intervals exceeding 1 week. Under the assumption of a causal relationship between timing of ANS and mortality, a simulation of ANS administered 3 hours before delivery to infants who did not receive ANS showed that their estimated decline in mortality would be 26%. Conclusions and Relevance: Antenatal corticosteroids may be effective even if given only hours before delivery. Therefore, the infants of pregnant women at risk of imminent preterm delivery may benefit from its use.


Assuntos
Intervalo entre Nascimentos/estatística & dados numéricos , Glucocorticoides/administração & dosagem , Mortalidade Hospitalar , Mortalidade Infantil , Cuidado Pré-Natal/métodos , Estudos de Coortes , Europa (Continente) , Feminino , Idade Gestacional , Glucocorticoides/efeitos adversos , Humanos , Lactente , Lactente Extremamente Prematuro , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/mortalidade , Masculino , Gravidez , Estudos Prospectivos
14.
Vaccine ; 35(16): 2084-2091, 2017 04 11.
Artigo em Inglês | MEDLINE | ID: mdl-28318766

RESUMO

INTRODUCTION: BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. METHODS: Within 7days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4weeks after the third vaccine dose. RESULTS: Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by 'age at randomisation' we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. CONCLUSIONS AND RELEVANCE: Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.


Assuntos
Anticorpos Antibacterianos/sangue , Formação de Anticorpos , Vacina BCG/imunologia , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/imunologia , Vacina Pneumocócica Conjugada Heptavalente/imunologia , Vacina Antipólio de Vírus Inativado/imunologia , Adjuvantes Imunológicos/administração & dosagem , Vacina BCG/administração & dosagem , Dinamarca , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Vacina Pneumocócica Conjugada Heptavalente/administração & dosagem , Humanos , Lactente , Recém-Nascido , Masculino , Vacina Antipólio de Vírus Inativado/administração & dosagem , Gravidez , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/imunologia
15.
Pediatr Res ; 81(6): 873-880, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28157835

RESUMO

BACKGROUND: The Bacillus Calmette-Guérin vaccine (BCG) has been associated with beneficial nonspecific effects on infant health. We aimed to examine the effect of BCG at birth on thymic size and the associations between thymic output, circulating lymphocytes, risk of infection, and thymic size. METHODS: In infants randomized to BCG or no BCG, thymic index (TI), and thymic/weight index (TWI) were measured by ultrasound at birth and at the age of 3 mo. T cell subpopulations including CD4+ T cells, CD8+ T cells, and recent thymic emigrants (RTEs) were assessed by flow cytometry. Infections up to age 3 mo were parent-reported. RESULTS: BCG vaccination did not affect thymic size at age 3 mo, measured as TI. At birth, the number of lymphocytes, CD4+ T cells, CD8+ T cells, and RTEs were positively associated with TI and TWI. Furthermore, a reduced risk of infections up to age 3 mo was associated with a large thymic size at birth. CONCLUSION: We found no effect of BCG vaccination on thymic size. The positive association between thymic output, lymphocytes, reduced risk of infections, and TI/TWI suggests that assessment of TI/TWI by ultrasound may be a predictor of the immunological capacity in the newborn.


Assuntos
Vacina BCG/administração & dosagem , Timo/anatomia & histologia , Subpopulações de Linfócitos B , Feminino , Citometria de Fluxo , Humanos , Recém-Nascido , Masculino , Subpopulações de Linfócitos T , Timo/diagnóstico por imagem , Timo/fisiologia
16.
Arch Dis Child ; 102(3): 224-231, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27443836

RESUMO

BACKGROUND: The BCG vaccine is administered to protect against tuberculosis, but studies suggest there may also be non-specific beneficial effects upon the infant immune system, reducing early non-targeted infections and atopic diseases. The present randomised trial tested the hypothesis that BCG vaccination at birth would reduce early childhood hospitalisation in Denmark, a high-income setting. METHODS: Pregnant women planning to give birth at three Danish hospitals were invited to participate. After parental consent, newborn children were allocated to BCG or no intervention within 7 days of age. Randomisation was stratified by prematurity. The primary study outcome was number of all-cause hospitalisations analysed as repeated events. Hospitalisations were identified using The Danish National Patient Register. Data were analysed by Cox proportional hazards models in intention-to-treat and per-protocol analyses. RESULTS: 4184 pregnant women were randomised and their 4262 children allocated to BCG or no intervention. There was no difference in risk of hospitalisation up to 15 months of age; 2129 children randomised to BCG experienced 1047 hospitalisations with a mean of 0.49 hospitalisation per child compared with 1003 hospitalisations among 2133 control children (mean 0.47), resulting in a HR comparing BCG versus no BCG of 1.05 (95% CI 0.93 to 1.18) (intention-to-treat analysis). The effect of BCG was the same in children born at term (1.05 (0.92 to 1.18)) and prematurely (1.07 (0.63 to 1.81), p=0.94). The effect was also similar in the two sexes and across study sites. The results were essentially identical in the per-protocol analysis and after adjustment for baseline characteristics. CONCLUSIONS: BCG vaccination at birth did not reduce the risk of hospitalisation for somatic acquired disease until 15 months of age in this Danish study population. TRIAL REGISTRATION NUMBER: NCT01694108, results.


Assuntos
Vacina BCG , Hospitalização/estatística & dados numéricos , Tuberculose/prevenção & controle , Pré-Escolar , Dinamarca , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Assistência Perinatal , Fatores de Risco , Fatores Socioeconômicos
17.
Dan Med J ; 63(7)2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27399977

RESUMO

INTRODUCTION: Since 2006, one hospital has offered two clinical courses in obstetrics/gynaecology and paediatrics to international (I) students. However, as I-student enrolment increased, the hospital faced cut-backs. As from 2010, I-team course evaluations therefore dropped to unacceptable levels and more I- than Danish (DK) students failed exams. Therefore, in 2012 we started a three-year internationalisation project (I-project) at two hospitals. The primary intervention was to pair training for I- and DK-students at clinical contact, and to offer an exclusive daily lecturer for I-teams. METHODS: We compared the course evaluations and exam grades of I-teams and DK-teams for two years prior to (107 from I-teams - 211 participants from DK-teams) and during the I-project (245 participants from I-teams - 575 from DK-teams). RESULTS: During the I-project, the I-teams' course evaluations increased to acceptable values and to levels comparable to the evaluation scores of DK-teams. Furthermore, I-students now considered that their communication with the patients was acceptable. Before the I-project, I-students had lower exam grades (median = 10 (range: 0-12)) than DK-students (10 (4-12)) (p = 0.03), but during the I-project, exam grades increased to the levels achieved by DK-students (10 (2-12) - 10 (0-12) (p = 0.22), and no more I- than DK-students failed exams (p = 0.51). CONCLUSIONS: Pairing students for clinical training and allocating an exclusive lecturer for I-teams produced improved courses for internationalisation. Allocating an exclusive lecturer was associated with a cost of about 615 EUR per student per course when the team consisted of ten students. FUNDING: The Capital Region of Denmark and the University of Copenhagen. TRIAL REGISTRATION: not relevant.


Assuntos
Educação de Graduação em Medicina/métodos , Ginecologia/educação , Obstetrícia/educação , Pediatria/educação , Estudantes de Medicina , Adulto , Dinamarca , Feminino , Humanos , Masculino , Estudos Retrospectivos , Adulto Jovem
18.
Pediatr Res ; 80(5): 681-685, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27429204

RESUMO

BACKGROUND: Childhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects. METHODS: A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation. RESULTS: The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07). CONCLUSION: This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.


Assuntos
Vacina BCG/uso terapêutico , Infecções Bacterianas/prevenção & controle , Controle de Doenças Transmissíveis , Dinamarca , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Mycobacterium tuberculosis , Gravidez , Reprodutibilidade dos Testes , Fatores de Tempo , Vacinação
19.
Early Hum Dev ; 100: 49-54, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27394195

RESUMO

BACKGROUND: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation. AIMS: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition. STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population. RESULTS: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months. CONCLUSION: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months. TRIAL REGISTRATION: www.clinicaltrials.gov, registration number NCT01694108.


Assuntos
Vacina BCG/efeitos adversos , Composição Corporal , Vacinação/efeitos adversos , Ganho de Peso , Antropometria , Estatura , Dinamarca , Feminino , Seguimentos , Idade Gestacional , Hospitais Universitários , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Valores de Referência , Pregas Cutâneas , Organização Mundial da Saúde
20.
Vaccine ; 34(22): 2477-82, 2016 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-27060379

RESUMO

OBJECTIVE: To evaluate adverse reactions of the Bacillus Calmette-Guérin (BCG) Statens Serum Institut (SSI) (Danish strain 1331) used as intervention in a randomized clinical trial. DESIGN: A randomized clinical multicenter trial, The Danish Calmette Study, randomizing newborns to BCG or no intervention. Follow-up until 13 months of age. SETTING: Pediatric and maternity wards at three Danish university hospitals. PARTICIPANTS: All women planning to give birth at the three study sites (n=16,521) during the recruitment period were invited to participate in the study. Four thousand one hundred and eighty four families consented to participate and 4262 children, gestational age 32 weeks and above, were randomized: 2129 to BCG vaccine and 2133 to no vaccine. None of the participants withdrew because of adverse reactions. MAIN OUTCOME AND MEASURE: Trial-registered adverse reactions after BCG vaccination at birth. Follow-up at 3 and 13 months by telephone interviews and clinical examinations. RESULTS: Among the 2118 BCG-vaccinated children we registered no cases of severe unexpected adverse reaction related to BCG vaccination and no cases of disseminated BCG disease. Two cases of regional lymphadenitis were hospitalized and thus classified as serious adverse reactions related to BCG. The most severe adverse reactions were 10 cases of suppurative lymphadenitis. This was nearly a fivefold increase compared to what was expected based on the summary of product characteristics of the vaccine. All cases were treated conservatively and recovered. Six of 10 (60%) families of children experiencing suppurative lymphadenitis compared to 117/2071 (6%) of those with no lymphadenitis indicated that the vaccine had more adverse effects than expected (p-value <0.001). CONCLUSIONS AND RELEVANCE: BCG vaccination was associated with only mild morbidity and no mortality. A higher incidence of suppurative lymphadenitis than expected was observed. All children were treated conservatively without sequelae or complications. TRIAL REGISTRATION: Trial registration number NCT01694108 at www.clinicaltrials.gov.


Assuntos
Vacina BCG/efeitos adversos , Vacina BCG/imunologia , Dinamarca/epidemiologia , Feminino , Seguimentos , Hospitais Universitários , Humanos , Lactente , Recém-Nascido , Linfadenite/etiologia , Masculino , Mortalidade , Mycobacterium bovis/imunologia , Tuberculose/epidemiologia , Tuberculose/microbiologia , Tuberculose/prevenção & controle , Vacinação
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