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1.
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
3.
J Pediatr ; 205: 293-294, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30448273
5.
JAMA ; 319(21): 2190-2201, 2018 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-29872859

RESUMO

Importance: There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. Objective: To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity. Design, Setting, and Participants: Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation. Exposures: Spo2 target range that was lower (85%-89%) vs higher (91%-95%). Main Outcomes and Measures: The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities. Results: A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003). Conclusions and Relevance: In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.


Assuntos
Deficiências do Desenvolvimento/epidemiologia , Enterocolite Necrosante/epidemiologia , Lactente Extremamente Prematuro , Doenças do Prematuro/epidemiologia , Oxigênio/sangue , Cegueira/epidemiologia , Paralisia Cerebral/epidemiologia , Surdez/epidemiologia , Feminino , Humanos , Incidência , Lactente , Mortalidade Infantil , Recém-Nascido , Doenças do Prematuro/mortalidade , Estimativa de Kaplan-Meier , Masculino , Oximetria , Oxigênio/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
Arch Dis Child Fetal Neonatal Ed ; 103(5): F430-F435, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28970321

RESUMO

BACKGROUND: Following recent recommendations, the oxygen saturation (SpO2) target range for preterm infants in our nursery was narrowed towards the higher end from 85%-95% to 90%-95%. We determined the effect of narrowing the SpO2 target range on the compliance in target range and distribution of SpO2 in preterm infants. METHODS: Before and after changing the target range from 85%-95% to 90%-95%, infants <30 weeks of gestation receiving oxygen were compared during their admission on the neonatal intensive care unit. For each infant, distribution of SpO2 was noted by collecting SpO2 samples each minute, and the percentage of time spent with SpO2 within 90%-95% was calculated. Oxygen was manually adjusted. Hypoxaemic events (SpO2 <80%) where oxygen was titrated were analysed. RESULTS: Data were analysed for 104 infants (57 before and 47 after the range was narrowed). The narrower range was associated with an increase in the median (IQR) SpO2 (93% (91%-96%) vs 94% (92%-97%), p=0.01), but no increase in median time SpO2 within 90%-95% (49.2% (39.6%-59.7%) vs (46.9% (27.1%-57.9%), p=0.72). The distribution of SpO2 shifted to the right with a significant decrease in SpO2 <90%, but not <80%. The count of minute values for Sp02 <80% decreased, while the frequency and duration of hypoxaemic events and oxygen titration were not different. CONCLUSION: Narrowing the target range from 85%-95% to 90%-95% in preterm infants was associated with an increase in median SpO2 and a rightward shift in the distribution, but no change in time spent between 90% and 95%.


Assuntos
Hipóxia , Consumo de Oxigênio/fisiologia , Oxigenoterapia , Feminino , Humanos , Hipóxia/diagnóstico , Hipóxia/etiologia , Hipóxia/terapia , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/diagnóstico , Doenças do Prematuro/fisiopatologia , Doenças do Prematuro/terapia , Unidades de Terapia Intensiva Neonatal/normas , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Masculino , Oximetria/métodos , Oxigenoterapia/métodos , Oxigenoterapia/normas
8.
Arch Dis Child Fetal Neonatal Ed ; 103(6): F567-F572, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29222087

RESUMO

BACKGROUND: The acid-base status of infants around birth can provide information about their past, current and future condition. Although umbilical cord blood pH <7.0 or base deficit ≥12 mmol/L is associated with increased risk of adverse outcome, there is uncertainty about the prognostic value of degree of acidosis as previous studies have used different variables, thresholds, outcomes and populations. METHODS: Retrospective review of routinely collected clinical data in all live-born inborn infants of 35 weeks gestation or more delivered between January 2005 and December 2013 at the Simpson Centre for Reproductive Health, Edinburgh, UK. Infants were included if their lowest recorded pH was <7 and/or highest base deficit ≥12 mmol/L on either umbilical cord blood and/or neonatal blood gas within 1 hour of birth. Neurodevelopmental outcome of the infants with encephalopathy was collected from the targeted follow-up database. RESULTS: 56 574 infants were eligible. 506 infants (0.9%) met inclusion criteria. Poor condition at birth and all adverse outcomes increased with worsening acidosis. Combined outcome of death or cerebral palsy was 3%, 10% and 40% at lowest pH of 6.9-6.99, 6.8-6.89 and <6.8, respectively, and 8%, 14% and 59% at a base deficit of 12-15.9, 16-19.9 and 20 mmol/L or more, respectively. CONCLUSIONS: There is a dose-dependent relationship between the degree of acidosis within an hour of delivery, and the likelihood of adverse neonatal and later neurodevelopmental outcome in infants born at 35 weeks gestation or more.


Assuntos
Acidose/complicações , Paralisia Cerebral/etiologia , Transtornos do Neurodesenvolvimento/etiologia , Acidose/mortalidade , Gasometria/métodos , Paralisia Cerebral/epidemiologia , Sangue Fetal/metabolismo , Humanos , Concentração de Íons de Hidrogênio , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Transtornos do Neurodesenvolvimento/epidemiologia , Oxigênio/sangue , Prognóstico , Estudos Retrospectivos , Medição de Risco/métodos , Taxa de Sobrevida , Reino Unido
9.
BMC Pregnancy Childbirth ; 17(1): 316, 2017 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-28938877

RESUMO

BACKGROUND: Metformin is widely used to treat gestational diabetes (GDM), but many women remain hyperglycaemic and require additional therapy. We aimed to determine recruitment rate and participant throughput in a randomised trial of glibenclamide compared with standard therapy insulin (added to maximum tolerated metformin) for treatment of GDM. METHODS: We conducted an open label feasibility study in 5 UK antenatal clinics among pregnant women 16 to 36 weeks' gestation with metformin-treated GDM. Women failing to achieve adequate glycaemic control on metformin monotherapy were randomised to additional glibenclamide or insulin. The primary outcome was recruitment rate. We explored feasibility with uptake, retention, adherence, safety, glycaemic control, participant satisfaction and clinical outcomes. RESULTS: Records of 197 women were screened and 23 women randomised to metformin and glibenclamide (n = 13) or metformin and insulin (n = 10). Mean (SD) recruitment rate was 0.39 (0.62) women/centre/month. 9/13 (69.2%, 95%CI 38.6-90.9%) women adhered to glibenclamide and all provided outcome data (100% retention). There were no episodes of severe hypoglycaemia, but metformin and insulin gave superior glycaemic control to metformin and glibenclamide, with fewer blood glucose readings <3.5 mmol/l (median [IQR] difference/woman/week of treatment 0.58 [0.03-1.87]). CONCLUSIONS: A large randomised controlled trial comparing glibenclamide or insulin in combination with metformin for women with GDM would be feasible but is unlikely to be worthwhile, given the poorer glycaemic control with glibenclamide and metformin in this pilot study. The combination of metformin and glibenclamide should be reserved for women with GDM with true needle phobia or inability to use insulin therapy. TRIAL REGISTRATION: www.clinicaltrials.gov registration number:NCT02080377 February 11th 2014.


Assuntos
Diabetes Gestacional/tratamento farmacológico , Glibureto/uso terapêutico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Seleção de Pacientes , Adulto , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Gestacional/sangue , Quimioterapia Combinada/métodos , Estudos de Viabilidade , Feminino , Humanos , Insulina/uso terapêutico , Adesão à Medicação , Gravidez
10.
Arch Dis Child Fetal Neonatal Ed ; 102(6): F497-F503, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28465315

RESUMO

OBJECTIVE: CHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of two human surfactant proteins. We planned to assess safety and tolerability of CHF5633 and explore preliminary efficacy. DESIGN: Multicentre cohort study. PATIENTS: Forty infants from 27+0 to 33+6 weeks gestation with respiratory distress syndrome requiring fraction of inspired oxygen (FiO2) ≥0.35 were treated with a single dose of CHF5633 within 48 hours after birth. The first 20 received 100 mg/kg and the second 20 received 200 mg/kg. OUTCOME MEASURES: Adverse events (AEs) and adverse drug reactions (ADRs) were monitored with complications of prematurity considered AEs if occurring after dosing. Systemic absorption and immunogenicity were assessed. Efficacy was assessed by change in FiO2 after dosing and need for poractant-alfa rescue. RESULTS: Rapid and sustained improvements in FiO2 were observed in 39 (98%) infants. One responded neither to CHF5633 nor two poractant-alfa doses. A total of 79 AEs were experienced by 19 infants in the 100 mg/kg cohort and 53 AEs by 20 infants in the 200 mg/kg cohort. Most AEs were expected complications of prematurity. Two unrelated serious AEs occurred in the second cohort. One infant died of necrotising enterocolitis and another developed viral bronchiolitis after discharge. The single ADR was an episode of transient endotracheal tube obstruction following a 200 mg/kg dose. Neither systemic absorption, nor antibody development to either peptide was detected. CONCLUSIONS: Both CHF5633 doses were well tolerated and showed promising clinical efficacy profile. These encouraging data provide a basis for ongoing randomised controlled trials. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01651637.


Assuntos
Fragmentos de Peptídeos/administração & dosagem , Fosfatidilcolinas/administração & dosagem , Proteína B Associada a Surfactante Pulmonar/administração & dosagem , Proteína C Associada a Surfactante Pulmonar/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Intubação Intratraqueal , Masculino , Fragmentos de Peptídeos/efeitos adversos , Fosfatidilcolinas/efeitos adversos , Proteína B Associada a Surfactante Pulmonar/efeitos adversos , Proteína C Associada a Surfactante Pulmonar/efeitos adversos , Surfactantes Pulmonares/efeitos adversos
11.
Cochrane Database Syst Rev ; 4: CD011190, 2017 04 11.
Artigo em Inglês | MEDLINE | ID: mdl-28398697

RESUMO

BACKGROUND: The use of supplemental oxygen in the care of extremely preterm infants has been common practice since the 1940s. Despite this, there is little agreement regarding which oxygen saturation (SpO2) ranges to target to maximise short- or long-term growth and development, while minimising harms. There are two opposing concerns. Lower oxygen levels (targeting SpO2 at 90% or less) may impair neurodevelopment or result in death. Higher oxygen levels (targeting SpO2 greater than 90%) may increase severe retinopathy of prematurity or chronic lung disease.The use of pulse oximetry to non-invasively assess neonatal SpO2 levels has been widespread since the 1990s. Until recently there were no randomised controlled trials (RCTs) that had assessed whether it is better to target higher or lower oxygen saturation levels in extremely preterm infants, from birth or soon thereafter. As a result, there is significant international practice variation and uncertainty remains as to the most appropriate range to target oxygen saturation levels in preterm and low birth weight infants. OBJECTIVES: 1. What are the effects of targeting lower versus higher oxygen saturation ranges on death or major neonatal and infant morbidities, or both, in extremely preterm infants?2. Do these effects differ in different types of infants, including those born at a very early gestational age, or in those who are outborn, without antenatal corticosteroid coverage, of male sex, small for gestational age or of multiple birth, or by mode of delivery? SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 4), MEDLINE via PubMed (1966 to 11 April 2016), Embase (1980 to 11 April 2016) and CINAHL (1982 to 11 April 2016). We also searched clinical trials databases, conference proceedings and the reference lists of retrieved articles for randomised controlled trials. SELECTION CRITERIA: Randomised controlled trials that enrolled babies born at less than 28 weeks' gestation, at birth or soon thereafter, and targeted SpO2 ranges of either 90% or below or above 90% via pulse oximetry, with the intention of maintaining such targets for at least the first two weeks of life. DATA COLLECTION AND ANALYSIS: We used the standard methods of Cochrane Neonatal to extract data from the published reports of the included studies. We sought some additional aggregate data from the original investigators in order to align the definitions of two key outcomes. We conducted the meta-analyses with Review Manager 5 software, using the Mantel-Haenszel method for estimates of typical risk ratio (RR) and risk difference (RD) and a fixed-effect model. We assessed the included studies using the Cochrane 'Risk of bias' and GRADE criteria in order to establish the quality of the evidence. We investigated heterogeneity of effects via pre-specified subgroup and sensitivity analyses. MAIN RESULTS: Five trials, which together enrolled 4965 infants, were eligible for inclusion. The investigators of these five trials had prospectively planned to combine their data as part of the NeOProM (Neonatal Oxygen Prospective Meta-analysis) Collaboration. We graded the quality of evidence as high for the key outcomes of death, major disability, the composite of death or major disability, and necrotising enterocolitis; and as moderate for blindness and retinopathy of prematurity requiring treatment.When an aligned definition of major disability was used, there was no significant difference in the composite primary outcome of death or major disability in extremely preterm infants when targeting a lower (SpO2 85% to 89%) versus a higher (SpO2 91% to 95%) oxygen saturation range (typical RR 1.04, 95% confidence interval (CI) 0.98 to 1.10; typical RD 0.02, 95% CI -0.01 to 0.05; 5 trials, 4754 infants) (high-quality evidence). Compared with a higher target range, a lower target range significantly increased the incidence of death at 18 to 24 months corrected age (typical RR 1.16, 95% CI 1.03 to 1.31; typical RD 0.03, 95% CI 0.01 to 0.05; 5 trials, 4873 infants) (high-quality evidence) and necrotising enterocolitis (typical RR 1.24, 95% 1.05 to 1.47; typical RD 0.02, 95% CI 0.01 to 0.04; 5 trials, 4929 infants; I² = 0%) (high-quality evidence). Targeting the lower range significantly decreased the incidence of retinopathy of prematurity requiring treatment (typical RR 0.72, 95% CI 0.61 to 0.85; typical RD -0.04, 95% CI -0.06 to -0.02; 5 trials, 4089 infants; I² = 69%) (moderate-quality evidence). There were no significant differences between the two treatment groups for major disability including blindness, severe hearing loss, cerebral palsy, or other important neonatal morbidities.A subgroup analysis of major outcomes by type of oximeter calibration software (original versus revised) found a significant difference in the treatment effect between the two software types for death (interaction P = 0.03), with a significantly larger treatment effect seen for those infants using the revised algorithm (typical RR 1.38, 95% CI 1.13 to 1.68; typical RD 0.06, 95% CI 0.01 to 0.10; 3 trials, 1716 infants). There were no other important differences in treatment effect shown by the subgroup analyses using the currently available data. AUTHORS' CONCLUSIONS: In extremely preterm infants, targeting lower (85% to 89%) SpO2 compared to higher (91% to 95%) SpO2 had no significant effect on the composite outcome of death or major disability or on major disability alone, including blindness, but increased the average risk of mortality by 28 per 1000 infants treated. The trade-offs between the benefits and harms of the different oxygen saturation target ranges may need to be assessed within local settings (e.g. alarm limit settings, staffing, baseline outcome risks) when deciding on oxygen saturation targeting policies.


Assuntos
Mortalidade Infantil , Lactente Extremamente Prematuro , Oxigênio/administração & dosagem , Oxigênio/sangue , Fatores Etários , Artérias , Cegueira/epidemiologia , Cegueira/etiologia , Paralisia Cerebral/epidemiologia , Enterocolite Necrosante/epidemiologia , Enterocolite Necrosante/etiologia , Humanos , Incidência , Lactente , Recém-Nascido , Oximetria , Oxigênio/efeitos adversos , Viés de Publicação , Ensaios Clínicos Controlados Aleatórios como Assunto , Retinopatia da Prematuridade/epidemiologia , Retinopatia da Prematuridade/etiologia , Retinopatia da Prematuridade/prevenção & controle , Viés de Seleção , Software
12.
BMC Pediatr ; 17(1): 39, 2017 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-28129748

RESUMO

BACKGROUND: In the UK, 1-2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth. METHODS/DESIGN: Two thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire. DISCUSSION: Extensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal feeding strategy, and therefore if successful, the trial results could rapidly be adopted across the NHS at low cost. TRIAL REGISTRATION: ISRCTN Registry; ISRCTN76463425 on 5 March, 2013.


Assuntos
Deficiências do Desenvolvimento/prevenção & controle , Nutrição Enteral/métodos , Doenças do Prematuro/prevenção & controle , Terapia Intensiva Neonatal/métodos , Leite Humano , Nutrição Parenteral/métodos , Pré-Escolar , Protocolos Clínicos , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Masculino , Estudos Prospectivos , Fatores de Tempo
13.
Eur J Pediatr ; 176(1): 99-107, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27888413

RESUMO

To study oxygen saturation (SpO2) targeting before and after training and guideline implementation of manual oxygen titration, two cohorts of preterm infants <30 weeks of gestation needing respiratory support and oxygen therapy were compared. The percentage of the time spent with SpO2 within the target range (85-95%) was calculated (%SpO2-wtr). SpO2 was collected every minute when oxygen is >21%. ABCs where oxygen therapy was given were identified and analyzed. After training and guideline implementation the %SpO2-wtr increased (median interquartile range (IQR)) 48.0 (19.6-63.9) % vs 61.9 (48.5-72.3) %; p < 0.005, with a decrease in the %SpO2 > 95% (44.0 (27.8-66.2) % vs 30.8 (22.6-44.5) %; p < 0.05). There was no effect on the %SpO2 < 85% (5.9 (2.8-7.9) % vs 6.2 (2.5-8) %; ns) and %SpO2 < 80% (1.9 (1.0-3.0) % vs 1.7 (0.8-2.6) %; ns). In total, 186 ABCs with oxygen therapy before and 168 ABCs after training and guideline implementation occurred. The duration of SpO2 < 80% reduced (2 (1-2) vs 1 (1-2) minutes; p < 0.05), the occurrence of SpO2 > 95% did not decrease (73% vs 64%; ns) but lasted shorter (2 (0-7) vs 1 (1-3) minute; p < 0.004). CONCLUSION: Training and guideline implementation in manual oxygen titration improved SpO2 targeting in preterm infants with more time spent within the target range and less frequent hyperoxaemia. The durations of hypoxaemia and hyperoxaemia during ABCs were shorter. What is Known: • Oxygen saturation targeting in preterm infants can be challenging and the compliance is low when oxygen is titrated manually. • Hyperoxaemia often occurs after oxygen therapy for oxygen desaturation during apnoeas. What is New: • Training and implementing guidelines improved oxygen saturation targeting and reduced hyperoxaemia. • Training and implementing guidelines improved manual oxygen titration during ABC.


Assuntos
Doenças do Prematuro/enfermagem , Terapia Intensiva Neonatal/métodos , Enfermagem Neonatal/educação , Oxigenoterapia/enfermagem , Oxigênio/sangue , Guias de Prática Clínica como Assunto , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Oximetria , Oxigênio/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos
15.
Neonatology ; 109(4): 352-8, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27250557

RESUMO

Five randomized controlled trials comparing lower (85-89%) versus higher (91-95%) pulse oximeter saturation (SpO2) targets for extremely preterm infants have now been reported from the United States of America, Canada, the United Kingdom, Australia and New Zealand. These trials included more than 4,800 infants, and they provide robust evidence to permit comparison of these target ranges and consider the next steps for clinicians and researchers. The lower SpO2 range was associated with a significant increase in the risk of death. There was no significant difference between the two target ranges in the rate of disability at 18-24 months, including blindness. A significant difference between groups in the risk of the composite primary outcome of death or disability in favour of the higher SpO2 range was mainly attributable to the difference between groups in the risk of death. The lower target range did not reduce bronchopulmonary dysplasia or severe visual impairment, but it did increase the risk of necrotizing enterocolitis requiring surgery or causing death. The trials provide no reason to prefer SpO2 targets below 90% and indicate the importance of more trials to see if a further survival advantage can be identified. The safety of targets above 95% has not been evaluated. The five trials were designed to be similar to facilitate an individual patient data meta-analysis, and this Neonatal Oxygen Prospective Meta-Analysis (NeOProM) may provide further insights.


Assuntos
Hiperóxia/complicações , Hipóxia/complicações , Mortalidade Infantil/tendências , Oxigenoterapia/efeitos adversos , Oxigenoterapia/normas , Cegueira/complicações , Cegueira/prevenção & controle , Displasia Broncopulmonar/complicações , Displasia Broncopulmonar/prevenção & controle , Humanos , Lactente , Lactente Extremamente Prematuro , Recém-Nascido , Terapia Intensiva Neonatal/métodos , Oximetria , Oxigênio/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Retinopatia da Prematuridade/complicações , Retinopatia da Prematuridade/prevenção & controle
16.
Acta Paediatr ; 105(9): 1061-6, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27228325

RESUMO

AIM: This study determined current international clinical practice and opinions regarding initial fractional inspired oxygen (FiO2 ) and pulse oximetry (SpO2 ) targets for delivery room resuscitation of preterm infants of less than 29 weeks of gestation. METHODS: An online survey was disseminated to neonatal clinicians via established professional clinical networks using a web-based survey programme between March 9 and June 30, 2015. RESULTS: Of the 630 responses from 25 countries, 60% were from neonatologists. The majority (77%) would target SpO2 between the 10th to 50th percentiles values for full-term infants. The median starting FiO2 was 0.3, with Japan using the highest (0.4) and the UK using the lowest (0.21). New Zealand targeted the highest SpO2 percentiles (median 50%). Most respondents agreed or did not disagree that a trial was required that compared the higher FiO2 of 0.6 (83%), targeting the 50th SpO2 percentile (60%), and the lower FiO2 of 0.21 (80%), targeting the 10th SpO2 percentile (78%). Most (65%) would join this trial. Many considered that evidence was lacking and further research was needed. CONCLUSION: Clinicians currently favour lower SpO2 targets for preterm resuscitation, despite acknowledging the lack of evidence for benefit or harm, and 65% would join a clinical trial.


Assuntos
Asfixia Neonatal/terapia , Neonatologistas/estatística & dados numéricos , Oxigênio/administração & dosagem , Ressuscitação , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Inquéritos e Questionários
17.
N Engl J Med ; 374(8): 749-60, 2016 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-26863265

RESUMO

BACKGROUND: The safest ranges of oxygen saturation in preterm infants have been the subject of debate. METHODS: In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial. RESULTS: After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001). CONCLUSIONS: Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses. (Funded by the Australian National Health and Medical Research Council and others; BOOST-II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry number, ACTRN12605000055606.).


Assuntos
Deficiências do Desenvolvimento/epidemiologia , Mortalidade Infantil , Lactente Extremamente Prematuro/sangue , Oxigenoterapia/métodos , Oxigênio/sangue , Austrália , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Oximetria , Oxigenoterapia/efeitos adversos , Risco , Reino Unido
19.
Arch Dis Child Fetal Neonatal Ed ; 99(1): F29-33, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23985883

RESUMO

PURPOSE: We tested the ability of the 'Weight, IGF-1, Neonatal Retinopathy of Prematurity (WINROP)' clinical algorithm to detect preterm infants at risk of severe Retinopathy of Prematurity (ROP) in a birth cohort in the South East of Scotland. In particular, we asked the question: 'are weekly weight measurements essential when using the WINROP algorithm?' STUDY DESIGN: This was a retrospective cohort study. Anonymised clinical data were uploaded to the online WINROP site, and infants at risk of developing severe ROP were identified. The results using WINROP were compared with the actual ROP screening outcomes. Infants with incomplete weight data were included in the whole group, but were excluded from a subgroup analysis of infants with complete weight data. In addition, data were manipulated to test whether missing weight data points in the early neonatal period would lead to loss of sensitivity of the algorithm. RESULTS: The WINROP algorithm had 73% sensitivity for detecting infants at risk of severe ROP when all infants were included and 87% when the complete weight data subgroup was analysed. Manipulation of data from the complete weight data subgroup demonstrated that one or two missing weight data points in the early postnatal period lead to loss of sensitivity performance by WINROP. IMPLICATIONS: The WINROP program offers a non-invasive method of identifying infants at high risk of severe ROP and also identifying those not at risk. However, for WINROP to function optimally, it has to be used as recommended and designed, namely weekly body weight measurements are required.


Assuntos
Algoritmos , Peso ao Nascer/fisiologia , Fator de Crescimento Insulin-Like I/metabolismo , Programas de Rastreamento/métodos , Retinopatia da Prematuridade/diagnóstico , Medição de Risco/métodos , Estudos de Coortes , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal , Masculino , Neovascularização Retiniana/sangue , Neovascularização Retiniana/diagnóstico , Retinopatia da Prematuridade/sangue , Estudos Retrospectivos , Fatores de Risco , Escócia , Sensibilidade e Especificidade
20.
Neonatology ; 103(4): 341-5, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23736013

RESUMO

Retinopathy of prematurity (ROP) was first observed soon after the widespread introduction of oxygen therapy into neonatal care. Early trials suggested that restricting oxygen supplementation could reduce ROP without other consequences, but when oxygen restriction became widespread, increased mortality was observed. These observations were made before continuous monitoring of oxygenation was possible. New trial evidence from masked randomized controlled trials of different pulse oximeter oxygen saturation (SpO2) target ranges now shows that targeting lower SpO2 levels reduces ROP but is associated with significantly increased mortality. These results illustrate the importance of randomized trials because, prior to these recent studies, trends in practice based on observational data were favouring lower SpO2. Follow-up data may yet further inform clinical practice.


Assuntos
Recém-Nascido Prematuro/sangue , Oxigenoterapia , Oxigênio/sangue , Biomarcadores/sangue , Humanos , Mortalidade Infantil , Recém-Nascido , Monitorização Fisiológica/métodos , Oximetria , Oxigenoterapia/efeitos adversos , Oxigenoterapia/mortalidade , Valor Preditivo dos Testes , Retinopatia da Prematuridade/sangue , Retinopatia da Prematuridade/etiologia , Retinopatia da Prematuridade/prevenção & controle , Medição de Risco , Resultado do Tratamento
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