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1.
N Engl J Med ; 382(3): 233-243, 2020 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-31940698

RESUMO

BACKGROUND: High-dose erythropoietin has been shown to have a neuroprotective effect in preclinical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however, the benefits and safety of this therapy in extremely preterm infants have not been established. METHODS: In this multicenter, randomized, double-blind trial of high-dose erythropoietin, we assigned 941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive erythropoietin or placebo within 24 hours after birth. Erythropoietin was administered intravenously at a dose of 1000 U per kilogram of body weight every 48 hours for a total of six doses, followed by a maintenance dose of 400 U per kilogram three times per week by subcutaneous injection through 32 completed weeks of postmenstrual age. Placebo was administered as intravenous saline followed by sham injections. The primary outcome was death or severe neurodevelopmental impairment at 22 to 26 months of postmenstrual age. Severe neurodevelopmental impairment was defined as severe cerebral palsy or a composite motor or composite cognitive score of less than 70 (which corresponds to 2 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition. RESULTS: A total of 741 infants were included in the per-protocol efficacy analysis: 376 received erythropoietin and 365 received placebo. There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80). There were no significant differences between the groups in the rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events. CONCLUSIONS: High-dose erythropoietin treatment administered to extremely preterm infants from 24 hours after birth through 32 weeks of postmenstrual age did not result in a lower risk of severe neurodevelopmental impairment or death at 2 years of age. (Funded by the National Institute of Neurological Disorders and Stroke; PENUT ClinicalTrials.gov number, NCT01378273.).


Assuntos
Eritropoetina/administração & dosagem , Lactente Extremamente Prematuro , Doenças do Prematuro/prevenção & controle , Transtornos do Neurodesenvolvimento/prevenção & controle , Encéfalo/diagnóstico por imagem , Pré-Escolar , Método Duplo-Cego , Eritropoetina/efeitos adversos , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Doenças do Prematuro/mortalidade , Masculino , Transtornos do Neurodesenvolvimento/epidemiologia , Ultrassonografia
2.
JAMA ; 322(19): 1877-1886, 2019 11 19.
Artigo em Inglês | MEDLINE | ID: mdl-31742630

RESUMO

Importance: Umbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation. Objective: To determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping. Design, Setting, and Participants: Noninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018. Interventions: Participants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238). Main Outcomes and Measures: The primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin. Results: Among 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002). Conclusions and Relevance: In this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT03019367.


Assuntos
Hemorragia Cerebral Intraventricular/prevenção & controle , Constrição , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Cordão Umbilical , Término Precoce de Ensaios Clínicos , Feminino , Idade Gestacional , Humanos , Lactente , Morte do Lactente , Recém-Nascido , Doenças do Prematuro/mortalidade , Masculino , Gravidez
3.
N Engl J Med ; 381(15): 1434-1443, 2019 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-31597020

RESUMO

BACKGROUND: Observational data have shown that slow advancement of enteral feeding volumes in preterm infants is associated with a reduced risk of necrotizing enterocolitis but an increased risk of late-onset sepsis. However, data from randomized trials are limited. METHODS: We randomly assigned very preterm or very-low-birth-weight infants to daily milk increments of 30 ml per kilogram of body weight (faster increment) or 18 ml per kilogram (slower increment) until reaching full feeding volumes. The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months. Secondary outcomes included components of the primary outcome, confirmed or suspected late-onset sepsis, necrotizing enterocolitis, and cerebral palsy. RESULTS: Among 2804 infants who underwent randomization, the primary outcome could be assessed in 1224 (87.4%) assigned to the faster increment and 1246 (88.7%) assigned to the slower increment. Survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 of 1224 infants (65.5%) assigned to the faster increment and 848 of 1246 (68.1%) assigned to the slower increment (adjusted risk ratio, 0.96; 95% confidence interval [CI], 0.92 to 1.01; P = 0.16). Late-onset sepsis occurred in 414 of 1389 infants (29.8%) in the faster-increment group and 434 of 1397 (31.1%) in the slower-increment group (adjusted risk ratio, 0.96; 95% CI, 0.86 to 1.07). Necrotizing enterocolitis occurred in 70 of 1394 infants (5.0%) in the faster-increment group and 78 of 1399 (5.6%) in the slower-increment group (adjusted risk ratio, 0.88; 95% CI, 0.68 to 1.16). CONCLUSIONS: There was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months in very preterm or very-low-birth-weight infants with a strategy of advancing milk feeding volumes in daily increments of 30 ml per kilogram as compared with 18 ml per kilogram. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; SIFT Current Controlled Trials number, ISRCTN76463425.).


Assuntos
Deficiências do Desenvolvimento/prevenção & controle , Nutrição Enteral/métodos , Fórmulas Infantis , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Leite Humano , Pré-Escolar , Nutrição Enteral/efeitos adversos , Enterocolite Necrosante/prevenção & controle , Seguimentos , Humanos , Recém-Nascido , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Unidades de Terapia Intensiva Neonatal , Tempo de Internação , Sepse/prevenção & controle
4.
Lakartidningen ; 1162019 Oct 08.
Artigo em Sueco | MEDLINE | ID: mdl-31593285

RESUMO

The recently documented high survival of extremely preterm infants in Sweden is related to a high degree of centralization of pre- and postnatal care and to recently issued national consensus guidelines providing recommendations for perinatal care at 22-24 gestational weeks. The prevalence of major neonatal morbidity remains high and exceeded 60 % in a recent study of extremely preterm infants born at < 27 gestational weeks delivered in Sweden in 2014-2016 and surviving to 1 year of age. Damage to immature organ systems inflicted during the neonatal period causes varying degrees of functional impairment with lasting effects in the growing child. There is an urgent need for evidence-based novel interventions aiming to prevent neonatal morbidity with a subsequent improvement of long-term outcome.


Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro , Nascimento Prematuro , Displasia Broncopulmonar/epidemiologia , Displasia Broncopulmonar/fisiopatologia , Displasia Broncopulmonar/prevenção & controle , Serviços Centralizados no Hospital , Hemorragia Cerebral/diagnóstico por imagem , Hemorragia Cerebral/epidemiologia , Hemorragia Cerebral/fisiopatologia , Hemorragia Cerebral/prevenção & controle , Ventrículos Cerebrais/irrigação sanguínea , Ventrículos Cerebrais/diagnóstico por imagem , Enterocolite Necrosante/epidemiologia , Enterocolite Necrosante/fisiopatologia , Enterocolite Necrosante/prevenção & controle , Feminino , Humanos , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Doenças do Prematuro/epidemiologia , Doenças do Prematuro/fisiopatologia , Doenças do Prematuro/prevenção & controle , Assistência Perinatal/organização & administração , Gravidez , Nascimento Prematuro/mortalidade , Retinopatia da Prematuridade/sangue , Retinopatia da Prematuridade/epidemiologia , Retinopatia da Prematuridade/fisiopatologia , Retinopatia da Prematuridade/prevenção & controle , Taxa de Sobrevida , Suécia/epidemiologia
5.
Cochrane Database Syst Rev ; 9: CD013201, 2019 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-31549743

RESUMO

BACKGROUND: Germinal matrix-intraventricular haemorrhage (GMH-IVH) remains a substantial issue in neonatal intensive care units worldwide. Current therapies to prevent or treat GMH-IVH are limited. Stem cell-based therapies offer a potential therapeutic approach to repair, restore, and/or regenerate injured brain tissue. These preclinical findings have now culminated in ongoing human neonatal studies. OBJECTIVES: To determine the benefits and harms of stem cell-based interventions for prevention or treatment of germinal matrix-intraventricular haemorrhage (GM-IVH) in preterm infants. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; MEDLINE via PubMed (1966 to 7 January 2019); Embase (1980 to 7 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 7 January 2019). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: We attempted to identify randomised controlled trials, quasi-randomised controlled trials, and cluster trials comparing (1) stem cell-based interventions versus control; (2) mesenchymal stromal cells (MSCs) of type or source versus MSCs of other type or source; (3) stem cell-based interventions other than MSCs of type or source versus stem cell-based interventions other than MSCs of other type or source; or (4) MSCs versus stem cell-based interventions other than MSCs. For prevention studies, we included extremely preterm infants (less than 28 weeks' gestation), 24 hours of age or less, without ultrasound diagnosis of GM-IVH; for treatment studies, we included preterm infants (less than 37 weeks' gestation), of any postnatal age, with ultrasound diagnosis of GM-IVH. DATA COLLECTION AND ANALYSIS: For each of the included trials, two review authors independently planned to extract data (e.g. number of participants, birth weight, gestational age, type and source of MSCs, other stem cell-based interventions) and assess the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). Primary outcomes considered in this review are all-cause neonatal mortality, major neurodevelopmental disability, GM-IVH, and extension of pre-existing non-severe GM-IVH. We planned to use the GRADE approach to assess the quality of evidence. MAIN RESULTS: Our search strategy yielded 769 references. We did not find any completed studies for inclusion. One randomised controlled trial is currently registered and ongoing. Five phase 1 trials are described in the excluded studies. AUTHORS' CONCLUSIONS: Currently no evidence is available to show the benefits or harms of stem cell-based interventions for treatment or prevention of GM-IVH in preterm infants.


Assuntos
Hemorragia Cerebral/prevenção & controle , Circulação Cerebrovascular/fisiologia , Mortalidade Infantil , Lactente Extremamente Prematuro , Doenças do Prematuro/prevenção & controle , Células-Tronco , Humanos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Doenças do Prematuro/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
Cochrane Database Syst Rev ; 8: CD012731, 2019 08 13.
Artigo em Inglês | MEDLINE | ID: mdl-31425619

RESUMO

BACKGROUND: Hyperbilirubinaemia occurs in approximately two-thirds of all newborns during the first days of life and is frequently treated with phototherapy. Although generally seen as safe, there is rising concern regarding phototherapy and its potentially damaging effects on DNA and increased side effects particularly for preterm infants. Other methods, such as enteral feeding supplementation with prebiotics, may have an effective use in the management of hyperbilirubinaemia in neonates. OBJECTIVES: To determine whether administration of prebiotics reduces the incidence of hyperbilirubinaemia among term and preterm infants compared with enteral supplementation of milk with distilled water/placebo or no supplementation. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 5), MEDLINE via PubMed (1966 to 14 June 2018), Embase (1980 to 14 June 2018), and CINAHL (1982 to 14 June 2018). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials. SELECTION CRITERIA: We considered all RCTs that studied neonates comparing enteral feeding supplementation with prebiotics versus distilled water/placebo or no supplementation. DATA COLLECTION AND ANALYSIS: Two reviewers screened papers and extracted data from selected papers. We used a fixed-effect method in combining the effects of studies that were sufficiently similar. We then used the GRADE approach to assess the quality of the evidence. MAIN RESULTS: Three small studies evaluating 154 infants were included in this review. One study reported a significant reduction in the risk of hyperbilirubinaemia and rate of treatment with phototherapy associated with enteral supplementation with prebiotics (risk ratio (RR) 0.75, 95% confidence interval (95% CI) 0.58 to 0.97; one study, 50 infants; low-quality evidence). Meta-analyses of two studies showed no significant difference in maximum plasma unconjugated bilirubin levels in infants with prebiotic supplementation (mean difference (MD) 0.14 mg/dL, 95% CI -0.91 to 1.20, I² = 81%, P = 0.79; two studies, 78 infants; low-quality evidence). There was no evidence of a significant difference in duration of phototherapy between the prebiotic and control groups, which was only reported by one study (MD 0.10 days, 95% CI -2.00 to 2.20; one study, 50 infants; low-quality evidence). The meta-analyses of two studies demonstrated a significant reduction in the length of hospital stay (MD -10.57 days, 95% CI -17.81 to -3.33; 2 studies, 78 infants; I² = 0%, P = 0.004; low-quality evidence). Meta-analysis of the three studies showed a significant increase in stool frequency in the prebiotic groups (MD 1.18, 95% CI 0.90 to 1.46, I² = 90%; 3 studies, 154 infants; high-quality evidence). No significant difference in mortality during hospital stay after enteral supplementation with prebiotics was reported (typical RR 0.94, 95% CI 0.14 to 6.19; I² = 6%, P = 0.95; 2 studies; 78 infants; low-quality evidence). There were no reports of the need for exchange transfusion and incidence of acute bilirubin encephalopathy, chronic bilirubin encephalopathy, and major neurodevelopmental disability in the included studies. None of the included studies reported any side effects. AUTHORS' CONCLUSIONS: Current studies are unable to provide reliable evidence about the effectiveness of prebiotics on hyperbilirubinaemia. Additional large, well-designed RCTs should be undertaken in neonates that compare effects of enteral supplementation with prebiotics on neonatal hyperbilirubinaemia with supplementation of milk with any other placebo (particularly distilled water) or no supplementation.


Assuntos
Hiperbilirrubinemia Neonatal/prevenção & controle , Prebióticos/administração & dosagem , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/prevenção & controle , Masculino , Fototerapia/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Pediatr Surg Int ; 35(10): 1143-1162, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31420743

RESUMO

PURPOSE: We aimed to compare probiotics with placebo for necrotizing enterocolitis in preterm infants and to evaluate the safety and effect and strict effect of specific probiotic genera. METHODS: Data recorded until January 2019 were searched, and relevant academic articles from PubMed, MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were selected by two independent reviewers. Two reviewers independently included randomized controlled trials that compared probiotics and placebo in preterm infants. The outcomes included more than one of the following outcomes: incidence of necrotizing enterocolitis, necrotizing enterocolitis-related mortality, incidence of sepsis, and all-cause mortality. Two reviewers independently extracted data and assessed the risk of bias and quality of evidence. RESULTS: We identified 34 eligible studies of 9161 participants. This meta-analysis showed an overall advantage of probiotics to prevent the incidence of necrotizing enterocolitis (3.54%) and gut-associated sepsis (15.59%), and decrease mortality (5.23%) in preterm infants. A probiotic mixture showed a huge advantage and vitality in preventing necrotizing enterocolitis (2.48%) and gut-associated sepsis (18.39%), and in reducing mortality (5.57%) in preterm infants. CONCLUSION: The probiotic mixture showed advantages over the single strains to decrease the incidences of necrotizing enterocolitis and gut-associated sepsis, and mortality in preterm infants.


Assuntos
Enterocolite Necrosante/prevenção & controle , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Guias de Prática Clínica como Assunto , Probióticos/administração & dosagem , Enterocolite Necrosante/epidemiologia , Saúde Global , Humanos , Incidência , Recém-Nascido , Doenças do Prematuro/epidemiologia
8.
Handb Clin Neurol ; 162: 315-328, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31324318

RESUMO

Despite notable advances in the care and survival of preterm infants, a significant proportion of preterm neonates will have life-long cognitive, behavioral, and motor deficits, and robustly effective neuroprotective strategies are still missing. These therapies must target the pathophysiologic mechanisms observed in contemporaneous infants and rely on modern epidemiology, imaging, and experimental models and assessment techniques. Two drugs, magnesium sulfate and caffeine, are already in use in several units, and although their targets are apnea of prematurity and myometrial contractility (respectively), they do offer improved odds of positive outcomes. Nevertheless, these drugs have limited efficacy, and NICU-to-NICU administration varies greatly. As such, there is an obvious need for additional specific neurotherapeutic strategies to further enhance the outcome of this very fragile population of neonates. The chapter reviews these issues, highlights bottlenecks that need to be solved for meaningful progress in the field, and proposes future innovative avenues for intervention, including delayed interventions.


Assuntos
Encefalopatias/prevenção & controle , Doenças do Prematuro/prevenção & controle , Neuroproteção , Adulto , Encefalopatias/congênito , Encefalopatias/fisiopatologia , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Gravidez
9.
Eur J Pediatr ; 178(9): 1317-1324, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31267223

RESUMO

Preterm infants are at risk of increased trans-epidermal water loss and infections due to epidermal immaturity. The emollient and anti-infective properties of coconut oil make it a potentially beneficial topical agent for this population. We aimed to systematically review randomised trials assessing the effects of topical coconut oil in preterm infants. Medline, EMBASE, Cochrane Central Register of Controlled Trials and CINAHL were searched. Seven trials (n = 727 infants) were included. The majority of trials included relatively mature infants (gestation > 32 weeks, birth weight > 1200 g). The duration of intervention (5-31 days) and outcomes of interest varied among included studies. Meta-analysis using random effects model found significantly lower incidence of hospital-acquired blood stream infections (HABSI) in the coconut oil group (11/164 vs 32/166; relative risk 0.35, 95% confidence interval 0.18, 0.67, p = 0.001; I2 = 0%, two RCTs). Overall, infants in the coconut oil group had decreased water loss, decreased infection rates, better growth and skin condition. There were no significant adverse effects associated with coconut oil application. The overall quality of evidence was considered moderate for the outcome of HABSI and low for the outcome of physical growth based on GRADE guidelines.Conclusion: Topical coconut oil application to the skin may be beneficial in preterm infants, but the quality of evidence is low to moderate. Adequately powered randomised controlled trials, especially in very preterm (< 32 weeks) and extremely preterm (< 28 weeks) infants, are needed. What is Known: • Coconut oil has been used traditionally for topical application in terms of infants in Asian countries What is New: • This systematic review found that topical application of coconut oil may reduce the risk of infection and improve weight gain and skin condition in preterm infants. However, the quality of evidence was considered to be moderate to low based on GRADE guidelines.


Assuntos
Anti-Infecciosos/uso terapêutico , Óleo de Coco/uso terapêutico , Desidratação/prevenção & controle , Emolientes/uso terapêutico , Doenças do Prematuro/prevenção & controle , Sepse Neonatal/prevenção & controle , Higiene da Pele/métodos , Administração Cutânea , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Ganho de Peso
10.
Neurosciences (Riyadh) ; 24(2): 101-109, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31056541

RESUMO

OBJECTIVE: To determine the effect of family-based intervention on motor function in preterm infants. METHODS: This study was designed as a randomized controlled trial between August 2015 and September 2016. Forty-two preterm infants were randomized and split equally between the family-based intervention group, composed of a physiotherapeutic and a familial component (8 males, 8 females; mean age 91+/-3.09 days), and the traditional early intervention group (8 females, 8 males, mean age: 91.06+/-2.4 days). Both groups received a treatment program based on a neurodevelopmental approach during 3- to 12-months-old. The groups were evaluated at corrected ages of the third, sixth, ninth, twelfth, and 24th months using the Bayley Scale of Infant and Toddler Development, Third Edition (Bayley-III). RESULTS: Within-group changes over time were statistically significant using multivariate tests of fine motor (Multivariate analysis of variance (MANOVA); F=1515.27, p less than 0.001) and gross motor (MANOVA; F=1950.59, p=0.001) development. However, there was no interaction between groups in fine (MANOVA; F=0.027, p=0.872) and gross motor development (MANOVA; F=0.022, p=0.883). CONCLUSION: The early intervention approaches might support fine and gross motor function development in preterm infants in the first year of life.


Assuntos
Deficiências do Desenvolvimento/prevenção & controle , Família , Doenças do Prematuro/prevenção & controle , Transtornos dos Movimentos/prevenção & controle , Modalidades de Fisioterapia , Cuidadores , Deficiências do Desenvolvimento/complicações , Feminino , Humanos , Lactente , Recém-Nascido Prematuro , Masculino , Transtornos dos Movimentos/complicações , Gravidez , Nascimento Prematuro , Resultado do Tratamento
11.
Neonatology ; 115(4): 371-378, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30965340

RESUMO

BACKGROUND: Recent studies reported conflicting results on the relationship between antenatal magnesium sulfate (MgSO4) exposure and neonatal intestinal injury. Most studies have not assessed MgSO4 exposure quantitatively and none reported the exposure timing. OBJECTIVES: The aim of this work was to assess whether there is a temporal or dose-dependent relationship between antenatal MgSO4 exposure and intestinal injury in extremely preterm neonates. METHODS: A retrospective study was made of inborn neonates with gestational age ≤28 weeks and/or birth weights ≤1,000 g. Primary outcomes included necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), and/or death prior to discharge or in the first 2 weeks of life. Outcome comparisons were made based on the timing of MgSO4 exposure, within 7 days (Mg7D) or within 3 days (Mg3D) of birth. Total cumulative doses for the Mg3D group were also computed. RESULTS: A total of 302 neonates were included, 210 in the Mg7D group, out of whom 179 (85.2%) constituted the Mg3D group. There were no differences noted when comparing MgSO4 exposure timing and the likelihood of NEC, SIP, and/or death. This remained the same for subgroup analysis of neonates < 26 weeks' gestation. Each 10-g increase in MgSO4 cumulative dose correlated with a decrease in SIP/NEC/death by 18.9% prior to discharge and by 21.9% in the first 2 weeks of life. Small for gestational age (SGA) was a potential effect modifier by a likelihood ratio test with p = 0.07. CONCLUSIONS: Antenatal MgSO4 exposure in extremely preterm neonates was not associated with an increased risk of intestinal injury or death, and might have reduced these complications in a dose-dependent manner in our study. This protective effect was more noticeable in SGA neonates.


Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro/induzido quimicamente , Perfuração Intestinal/induzido quimicamente , Sulfato de Magnésio/efeitos adversos , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , California , Relação Dose-Resposta a Droga , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Doenças do Prematuro/prevenção & controle , Recém-Nascido Pequeno para a Idade Gestacional , Modelos Logísticos , Sulfato de Magnésio/administração & dosagem , Masculino , Análise Multivariada , Gravidez , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Estudos Retrospectivos
12.
PLoS One ; 14(4): e0215150, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30970001

RESUMO

OBJECTIVES: To assess premedication practices before tracheal intubation of premature newborns in the delivery room (DR). STUDY DESIGN: From the national population-based prospective EPIPAGE 2 cohort in 2011, we extracted all live born preterms intubated in the DR in level-3 centers, without subsequent circulatory resuscitation. Studied outcomes included the rate and type of premedication, infants' and maternities' characteristics and survival and major neonatal morbidities at discharge from hospital. Univariate and multivariate analysis were performed and a generalized estimating equation was used to identify factors associated with premedication use. RESULTS: Out of 1494 included neonates born in 65 maternities, 76 (5.1%) received a premedication. Midazolam was the most used drug accounting for 49% of the nine drugs regimens observed. Premedicated, as compared to non premedicated neonates, had a higher median [IQR] gestational age (30 [28-31] vs 28 [27-30] weeks, p<10-3), median birth weight (1391 [1037-1767] vs 1074 [840-1440] g, p<10-3) and median 1-minute Apgar score (8 [6-9] vs 6 [3-8], p<10-3). Using univariate analyses, premedication was significantly less frequent after maternal general anesthesia and during nighttime and survival without major morbidity was significantly higher among premedicated neonates (56/73 (81.4%) vs 870/1341 (69.3%), p = 0.028). Only 10 centers used premedication at least once and had characteristics comparable to the 55 other centers. In these 10 centers, premedication rates varied from 2% to 75%, and multivariate analysis identified gestational age and 1-minute Apgar score as independent factors associated with premedication use. CONCLUSION: Premedication rate before tracheal intubation was only 5.1% in the DR of level-3 maternities for premature neonates below 34 weeks of gestation in France in 2011 and seemed to be mainly associated with centers' local policies.


Assuntos
Doenças do Prematuro/prevenção & controle , Midazolam/uso terapêutico , Pré-Medicação/métodos , Peso ao Nascer , Estudos de Coortes , Salas de Parto , Feminino , França/epidemiologia , Idade Gestacional , Humanos , Recém-Nascido , Doenças do Prematuro/epidemiologia , Intubação Intratraqueal , Masculino , Morbidade , Gravidez , Estudos Retrospectivos , Fatores de Risco
14.
Rev. logop. foniatr. audiol. (Ed. impr.) ; 39(1): 32-40, ene.-mar. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-176638

RESUMO

Introducción: La interacción temprana madre-hijo es crítica para el desarrollo adecuado del lactante; sin embargo, la interacción de los padres con los lactantes prematuros presenta una dificultad particular por las circunstancias que acompañan un nacimiento prematuro, como son los factores de riesgo de daño cerebral, y la necesidad de estimulación temprana tanto motora como cognitiva que demandan estos bebés. Se ha observado que los programas educativos tienen efectos positivos en los padres de lactantes prematuros ya que mejoran los resultados de sus hijos en evaluaciones motrices, cognitivas y del lenguaje. Método: En este trabajo se examina el efecto de un programa de educación para padres para estimular el desarrollo de las habilidades comunicativas de los lactantes prematuros. Se examinó cómo cambió la interacción padres-hijo después del programa de intervención. Adicionalmente, se compararon los resultados de las evaluaciones de lenguaje de los niños, hijos de los padres que participaron en el programa de intervención comparados con niños pares, hijos de padres que no participaron en dicho programa. Resultados: El programa contribuyó a cambiar la interacción de los padres con los lactantes y a mejorar los puntajes en las evaluaciones posteriores del lenguaje de sus hijos. Conclusión: Se recomienda la participación de los padres de niños prematuros en programas de educación para padres para estimular el desarrollo del lenguaje de sus hijos


Introduction: Early mother-child interaction is critical for proper infant development; however, the interaction of parents with preterm infants presents a particular difficulty due to the circumstances that accompany premature birth, such as risk factors for brain damage and the early motor and cognitive stimulation that these infants demand. It has been observed that educational programmes have positive effects on the parents of preterm infants as they improve the outcomes of their children in motor, cognitive and language assessments. Method: This paper examines the effect of a parent education programme designed to stimulate the development of the early communicative skills of preterm infants. We examined how the parent-child interaction changed following the intervention programme. In addition, the results of the language evaluations of the children whose parents participated in the intervention programme and those whose parents did not participate were compared. Results: The programme helped to change the interaction of parents with their infants and to improve scores in the children's subsequent language assessments. Conclusion: Parents of premature children are encouraged to participate in parent education programmes to encourage the development of their child's language abilities


Assuntos
Humanos , Masculino , Feminino , Lactente , Dano Encefálico Crônico/reabilitação , Transtornos do Desenvolvimento da Linguagem/reabilitação , Terapia da Linguagem/métodos , Intervenção Precoce (Educação)/tendências , Doenças do Prematuro/prevenção & controle , Pais/educação , Relações Pais-Filho , Habilidades Sociais
15.
Am J Obstet Gynecol ; 220(5): 482.e1-482.e8, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30786254

RESUMO

BACKGROUND: It has been established that delayed umbilical cord clamping in preterm infants results in improvement in neonatal anemia, need for transfusion, incidence of necrotizing enterocolitis, and intraventricular hemorrhage by increasing neonatal circulating blood volume. However, the effects of umbilical cord milking as an alternative to delayed clamping in preterm infants are unclear. OBJECTIVE: The primary objective of this study was to compare the effect of delayed clamping vs milking of the umbilical cord on the initial hematocrit concentration in preterm births (23-34 weeks gestation). In addition, we sought to compare the effects of delayed clamping vs milking on the incidences of intraventricular hemorrhage, necrotizing enterocolitis, and need for transfusion (secondary objectives). STUDY DESIGN: The study was an unblinded randomized controlled trial of singleton preterm infants who were born 23 weeks 0 days to 34 weeks 6 days gestation and were assigned to 1 of 2 controlled study groups: delayed cord clamping for 60 seconds or milking of the cord towards the infant 4 times before clamping. Randomization occurred via block randomization with an allocation ratio of 1 to 1. The patients' third stage of delivery was standardized for route of delivery and randomization arm. All comparisons were preformed with an intent-to-treat analysis approach. The study was powered at 80% with a probability value of .05 for the primary outcome measure of a hematocrit difference of 3% between the 2 groups. RESULTS: Of the 204 randomized patients, 104 were assigned to the delayed subgroup, and 100 were assigned to the milking subgroup. There were no significant differences in baseline maternal characteristics noted between groups. Though there was not any statistically significant difference in neonatal outcomes between the cord clamping and milking groups, the occurrences of transfusion (15.5% vs 9.1%; P=.24), necrotizing enterocolitis (5.8% vs 3.0%; P=.49), and intraventricular hemorrhage (15.5% vs 10.1%; P=.35) were all lower in the milking group. The milking group had higher initial hematocrit concentration compared with the delayed clamping group, although this was not significant (51.8 [6.2%] vs 49.9 [7.7%]; P=.07]. Peak bilirubin levels and need for phototherapy were similar between groups. CONCLUSION: This study demonstrates that milking the umbilical cord may be an acceptable alternative to delayed cord clamping because there were similar effects on neonatal hematocrit concentrations and the need for neonatal transfusions and no increased risk for complications or neonatal morbidity. The present data support the concept that milking of the umbilical cord may offer an efficient and timely method of providing increased blood volume to the infant.


Assuntos
Constrição , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Cordão Umbilical , Adolescente , Adulto , Transfusão de Sangue/estatística & dados numéricos , Hemorragia Cerebral Intraventricular/prevenção & controle , Enterocolite Necrosante/prevenção & controle , Feminino , Hematócrito , Humanos , Recém-Nascido , Pessoa de Meia-Idade , Gravidez , Fatores de Tempo , Adulto Jovem
16.
Eur J Obstet Gynecol Reprod Biol ; 234: 32-37, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30639954

RESUMO

OBJECTIVE: The purpose of this review is to describe the historical and scientific basis of antenatal corticosteroids (ACS) therapy, to improve the management of preterm birth and decreasing rates of respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis and perinatal mortality in premature infants. STUDY DESIGN: We searched MEDLINE/PubMed electronic database, the Cochrane Library, using medical subheading search words such as "ACS", "corticosteroids", "betamethasone" or "dexamethasone", matching with "preterm birth". RESULTS: This practice was initiated by Liggins and Howie in 1972 and is supported by the initial comprehensive meta-analysis of Crowley, Chambers and Keirse, in 1990, the NIH Consensus Development Conference in 1994, the second Consensus Conference to evaluate repeated courses of corticosteroids in 2000 and the practice recommendations of obstetric societies worldwide. ACS therapy before anticipated preterm birth is one of the most important antenatal therapies and an important evidence-based practice for reducing mortality, and decreasing rates of complications in premature infants. CONCLUSIONS: Today, there is no controversy that women with preterm birth <34 weeks should be ACS treated. Actually, rescue courses are recommended; while multiple, serial, repeated or weekly courses, are not recommended. In any clinical conditions, as preterm premature rupture of membranes, multiple pregnancies, severe preeclampsia/HELLP syndrome and fetal growth restriction; ACS is recommended.


Assuntos
Corticosteroides/administração & dosagem , Betametasona/administração & dosagem , Dexametasona/administração & dosagem , Nascimento Prematuro/tratamento farmacológico , Corticosteroides/efeitos adversos , Animais , Betametasona/efeitos adversos , Conferências de Consenso como Assunto , Dexametasona/efeitos adversos , Feminino , Maturidade dos Órgãos Fetais/efeitos dos fármacos , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/prevenção & controle , Pulmão/embriologia , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Neonatal Netw ; 38(1): 7-16, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30679251

RESUMO

Expressed breast milk (EBM) is the gold standard of infant nutrition, but is not always available for use for preterm infants in the NICU setting. Donor breast milk (DBM) is often a preferred alternative for preterm and very low birth weight (VLBW) infants when maternal milk is not available. This article discusses the composition of DBM, reviews its advantages compared to formula, discusses challenges related to its long-term use, and identifies strategies to utilize DBM in the context of total nutritional management of preterm and VLBW infants. We will use a framework of WHO, WHAT, WHERE, WHEN, and WHY to answer the questions: who gets DBM, why use DBM, where does DBM come from, what is in DBM, and when may DBM use be challenged.


Assuntos
Fórmulas Infantis , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Bancos de Leite , Leite Humano , Administração dos Cuidados ao Paciente/métodos , Feminino , Humanos , Fórmulas Infantis/análise , Fórmulas Infantis/química , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido Prematuro/fisiologia , Doenças do Prematuro/prevenção & controle , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Recém-Nascido de muito Baixo Peso/fisiologia , Masculino , Bancos de Leite/organização & administração , Bancos de Leite/normas , Leite Humano/química , Leite Humano/fisiologia
18.
JAMA ; 321(4): 354-363, 2019 01 29.
Artigo em Inglês | MEDLINE | ID: mdl-30694322

RESUMO

Importance: Dexamethasone initiated after the first week of life reduces the rate of death or bronchopulmonary dysplasia (BPD) but may cause long-term adverse effects in very preterm infants. Hydrocortisone is increasingly used as an alternative, but evidence supporting its efficacy and safety is lacking. Objective: To assess the effect of hydrocortisone initiated between 7 and 14 days after birth on death or BPD in very preterm infants. Design, Setting, and Participants: Double-blind, placebo-controlled randomized trial conducted in 19 neonatal intensive care units in the Netherlands and Belgium from November 15, 2011, to December 23, 2016, among preterm infants with a gestational age of less than 30 weeks and/or birth weight of less than 1250 g who were ventilator dependent between 7 and 14 days of life, with follow-up to hospital discharge ending December 12, 2017. Interventions: Infants were randomly assigned to receive a 22-day course of systemic hydrocortisone (cumulative dose, 72.5 mg/kg) (n = 182) or placebo (n = 190). Main Outcomes and Measures: The primary outcome was a composite of death or BPD assessed at 36 weeks' postmenstrual age. Twenty-nine secondary outcomes were analyzed up to hospital discharge, including death and BPD at 36 weeks' postmenstrual age. Results: Among 372 patients randomized (mean gestational age, 26 weeks; 55% male), 371 completed the trial; parents withdrew consent for 1 child treated with hydrocortisone. Death or BPD occurred in 128 of 181 infants (70.7%) randomized to hydrocortisone and in 140 of 190 infants (73.7%) randomized to placebo (adjusted risk difference, -3.6% [95% CI, -12.7% to 5.4%]; adjusted odds ratio, 0.87 [95% CI, 0.54-1.38]; P = .54). Of 29 secondary outcomes, 8 showed significant differences, including death at 36 weeks' postmenstrual age (15.5% with hydrocortisone vs 23.7% with placebo; risk difference, -8.2% [95% CI, -16.2% to -0.1%]; odds ratio, 0.59 [95% CI, 0.35-0.995]; P = .048). Twenty-one outcomes showed nonsignificant differences, including BPD (55.2% with hydrocortisone vs 50.0% with placebo; risk difference, 5.2% [95% CI, -4.9% to 15.2%]; odds ratio, 1.24 [95% CI, 0.82-1.86]; P = .31). Hyperglycemia requiring insulin therapy was the only adverse effect reported more often in the hydrocortisone group (18.2%) than in the placebo group (7.9%). Conclusions and Relevance: Among mechanically ventilated very preterm infants, administration of hydrocortisone between 7 and 14 days after birth, compared with placebo, did not improve the composite outcome of death or BPD at 36 weeks' postmenstrual age. These findings do not support the use of hydrocortisone for this indication. Trial Registration: Netherlands National Trial Register Identifier: NTR2768.


Assuntos
Anti-Inflamatórios/administração & dosagem , Displasia Broncopulmonar/prevenção & controle , Hidrocortisona/administração & dosagem , Doenças do Prematuro/mortalidade , Recém-Nascido de muito Baixo Peso , Anti-Inflamatórios/efeitos adversos , Método Duplo-Cego , Humanos , Hidrocortisona/efeitos adversos , Incidência , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/prevenção & controle , Unidades de Terapia Intensiva Neonatal , Respiração Artificial , Tempo para o Tratamento , Falha de Tratamento
19.
Lancet ; 393(10170): 423-433, 2019 02 02.
Artigo em Inglês | MEDLINE | ID: mdl-30635141

RESUMO

BACKGROUND: Infections acquired in hospital are an important cause of morbidity and mortality in very preterm infants. Several small trials have suggested that supplementing the enteral diet of very preterm infants with lactoferrin, an antimicrobial protein processed from cow's milk, prevents infections and associated complications. The aim of this large randomised controlled trial was to collect data to enhance the validity and applicability of the evidence from previous trials to inform practice. METHODS: In this randomised placebo-controlled trial, we recruited very preterm infants born before 32 weeks' gestation in 37 UK hospitals and younger than 72 h at randomisation. Exclusion criteria were presence of a severe congenital anomaly, anticipated enteral fasting for longer than 14 days, or no realistic prospect of survival. Eligible infants were randomly assigned (1:1) to receive either enteral bovine lactoferrin (150 mg/kg per day; maximum 300 mg/day; lactoferrin group) or sucrose (same dose; control group) once daily until 34 weeks' postmenstrual age. Web-based randomisation minimised for recruitment site, gestation (completed weeks), sex, and single versus multifetal pregnancy. Parents, caregivers, and outcome assessors were unaware of group assignment. The primary outcome was microbiologically confirmed or clinically suspected late-onset infection (occurring >72 h after birth), which was assessed in all participants for whom primary outcome data was available by calculating the relative risk ratio with 95% CI between the two groups. The trial is registered with the International Standard Randomised Controlled Trial Number 88261002. FINDINGS: We recruited 2203 participants between May 7, 2014, and Sept 28, 2017, of whom 1099 were assigned to the lactoferrin group and 1104 to the control group. Four infants had consent withdrawn or unconfirmed, leaving 1098 infants in the lactoferrin group and 1101 in the sucrose group. Primary outcome data for 2182 infants (1093 [99·5%] of 1098 in the lactoferrin group and 1089 [99·0] of 1101 in the control group) were available for inclusion in the modified intention-to-treat analyses. 316 (29%) of 1093 infants in the intervention group acquired a late-onset infection versus 334 (31%) of 1089 in the control group. The risk ratio adjusted for minimisation factors was 0·95 (95% CI 0·86-1·04; p=0·233). During the trial there were 16 serious adverse events for infants in the lactoferrin group and 10 for infants in the control group. Two events in the lactoferrin group (one case of blood in stool and one death after intestinal perforation) were assessed as being possibly related to the trial intervention. INTERPRETATION: Enteral supplementation with bovine lactoferrin does not reduce the risk of late-onset infection in very preterm infants. These data do not support its routine use to prevent late-onset infection and associated morbidity or mortality in very preterm infants. FUNDING: UK National Institute for Health Research Health Technology Assessment programme (10/57/49).


Assuntos
Anti-Infecciosos/administração & dosagem , Infecção Hospitalar/prevenção & controle , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Lactoferrina/administração & dosagem , Sepse/prevenção & controle , Feminino , Humanos , Recém-Nascido , Masculino , Resultado do Tratamento , Reino Unido
20.
Z Geburtshilfe Neonatol ; 223(1): 26-32, 2019 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-30513543

RESUMO

INTRODUCTION: Worldwide, 37 million people are infected with HIV; more than 50% are women. Currently, MTCT (mother-to-child transmission) can be reduced to<1%. The intention of the present study was to analyze the development of (1) the course of pregnancy of HIV-infected women, (2) the mode of delivery and (3) the post-exposure prophylaxis of the newborn over the last decade. METHODOLOGY: In this retrospective study, data from HIV-infected women who between 2005 and 2016 received care at the HIV outpatient department and gave birth at the Department of Obstetrics at University Hospital Bonn was analyzed. Furthermore, neonatal data was collected and HIV-MTCT was evaluated. RESULTS: In the 2005-2016 study period, 87 pregnancies in 61 women were identified. Seventy babies were born alive at the Department of Obstetrics, University Hospital Bonn. 53% of these women were of African origin. The median of CD4+ cell count was 510 cells/ml (IQR 444); however, 32 women (52%) had more than 500 cells/ml. During the antenatal period, the HI viral load had been suppressed completely in 77% of women (<50 HIV-1-RNA copies/ml) and was<400 HIV-1-RNA copies/ml in 92% of women. The elective cesarean section rate fell significantly from 77% in the years 2005-2011 to 58% in 2012-2016. The proportion of deliveries after 37 weeks of gestation increased markedly from 60% to 69% after 2012. Additionally, while between 2005-2011 the birth weight of 78% of the newborns was between the 10th and 90th percentile, this proportion increased to 92% after 2012. Fifty-four of 70 newborns (77%) were classified as having low to normal HIV transmission risk. A vertical HIV transmission from mother to child did not occur (0/70). CONCLUSIONS: Between 2005 and 2016 no vertical HIV transmission from mother to child occurred (0/70). Due to the change in treatment strategy, the elective cesarean section rate fell significantly as well the rate of premature births. An optimal interdisciplinary collaboration builds the basis for successful treatment of HIV in pregnancy.


Assuntos
Terapia Antirretroviral de Alta Atividade , Cesárea , Infecções por HIV/tratamento farmacológico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Feminino , Alemanha , Infecções por HIV/diagnóstico , Infecções por HIV/transmissão , Humanos , Recém-Nascido , Doenças do Prematuro/prevenção & controle , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Trabalho de Parto Prematuro/prevenção & controle , Profilaxia Pós-Exposição , Gravidez , Complicações Infecciosas na Gravidez/diagnóstico , Estudos Retrospectivos
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