RESUMO
OBJECTIVE: To study the association between discontinuing predischarge car seat tolerance screening (CSTS) with 30-day postdischarge adverse outcomes in infants born preterm. STUDY DESIGN: Retrospective cohort study involving all infants born preterm from 2010 through 2021 who survived to discharge to home in a 14-hospital integrated health care system. The exposure was discontinuation of CSTS. The primary outcome was a composite rate of death, 911 call-triggered transports, or readmissions associated with diagnostic codes of respiratory disorders, apnea, apparent life-threatening event, or brief resolved unexplained events within 30 days of discharge. Outcomes of infants born in the periods of CSTS and after discontinuation were compared. RESULTS: Twelve of 14 hospitals initially utilized CSTS and contributed patients to the CSTS period; 71.4% of neonatal intensive care unit (NICU) patients and 26.9% of non-NICU infants were screened. All hospitals participated in the discontinuation period; 0.1% was screened. Rates of the unadjusted primary outcome were 1.02% in infants in the CSTS period (n = 21â122) and 1.06% after discontinuation (n = 20â142) (P = .76). The aOR (95% CI) was 0.95 (0.75, 1.19). Statistically insignificant differences between periods were observed in components of the primary outcome, gestational age strata, NICU admission status groups, and other secondary analyses. CONCLUSIONS: Discontinuation of CSTS in a large integrated health care network was not associated with a change in 30-day postdischarge adverse outcomes. CSTS's value as a standard predischarge assessment deserves further evaluation.
Assuntos
Sistemas de Proteção para Crianças , Recém-Nascido Prematuro , Recém-Nascido , Humanos , Lactente , Sistemas de Proteção para Crianças/efeitos adversos , Alta do Paciente , Estudos Retrospectivos , Assistência ao Convalescente , Unidades de Terapia Intensiva NeonatalRESUMO
BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.
Assuntos
Doenças do Recém-Nascido , Clampeamento do Cordão Umbilical , Cordão Umbilical , Feminino , Humanos , Recém-Nascido , Gravidez , Transfusão de Sangue , Constrição , Estudos Cross-Over , Hemoglobinas , Hipóxia-Isquemia Encefálica/etiologia , Recém-Nascido Prematuro , Placenta , Cordão Umbilical/cirurgia , Clampeamento do Cordão Umbilical/métodos , Doenças do Prematuro/cirurgia , Doenças do Prematuro/terapia , Doenças do Recém-Nascido/cirurgia , Doenças do Recém-Nascido/terapiaRESUMO
Moral values in healthcare range widely between interest groups and are principally subjective. Disagreements diminish dialogue and marginalize alternative viewpoints. Extremely premature births exemplify how discord becomes unproductive when conflicts of interest, cultural misunderstanding, constrained evidence review, and peculiar hierarchy compete without the balance of objective standards of reason. Accepting uncertainty, distributing risk fairly, and humbly acknowledging therapeutic limits are honorable traits, not relativism, and especially crucial in our world of constrained resources. We think dialogics engender a mutual understanding that: i) transitions beliefs beyond bias, ii) moves conflict toward pragmatism (i.e., the truth of any position is verified by subsequent experience), and iii) recognizes value pluralism (i.e., human values are irreducibly diverse, conflicting, and ultimately incommensurable). This article provides a clear and useful Point-Counterpoint of extreme prematurity controversies, an objective neurodevelopmental outcomes table, and a dialogics exemplar to cultivate shared empathetic comprehension, not to create sides from which to choose. It is our goal to bridge the understanding gap within and between physicians and bioethicists. Dialogics accept competing relational interests as human nature, recognizing that ultimate solutions satisfactory to all are illusory, because every choice has downside. Nurturing a collective consciousness via dialogics and pragmatism is congenial to integrating objective evidence review and subjective moral-cultural sentiments, and is that rarest of ethical constructs, a means and an end.
Assuntos
Nascimento Prematuro , Gravidez , Feminino , Humanos , Princípios Morais , Incerteza , Atenção à Saúde , Diversidade CulturalRESUMO
OBJECTIVES: The Triple Aim is widely regarded as the quality improvement gold standard that enhances population health, lowers costs, and betters individual care. There have been no large-scale, sustained demonstrations of such improvement in healthcare. Illustrating the Triple Aim using relevant extremely premature infant outcomes might highlight interwoven proficiency and efficiency complexities that impede sustained value progress. STUDY DESIGN: Ten long-term collaborating neonatal intensive care units (NICU) in the Vermont Oxford Network calculated the Triple Aim in 230/7 to 276/7-week infants using three surrogate measures: (1) population health/x-axis-eight major morbidity rates as a composite, risk-adjusted metric; (2) cost/y-axis-total hospital length of stay; and (3) individual care/z-axis-mortality, then illustrated this relationship as a sphere within a three-dimensional cube. RESULTS: Three thousand seven hundred six infants born between January 1, 2014 and December 31, 2019, with mean (standard deviation) gestational age of 25.7 (1.4) weeks and birth weight of 803 (208) grams were analyzed. Triple Aim three-axis cube positions varied inconsistently comparing NICUs. Each NICUs' sphere illustrated mixed x- and z-axis movement (clinical proficiency), and y-axis movement (cost efficiency). No NICU demonstrated the theoretically ideal Triple Aim improvement in all three axes. Backward movement in at least one axis occurred in eight NICUs. The whole-group Triple Aim sphere moved forward along the x-axis (better morbidities metric), but moved backward in the y-axis length of stay and z-axis mortality measurements. CONCLUSION: Illustrating the Triple Aim gold standard as extreme prematurity outcomes reveals complexities inherent to simultaneous attempts at improving interwoven quality and cost outcomes. Lack of progress using relevant Triple Aim parameters from our well-established collaboration highlights the difficulties prioritizing competing outcomes, variable potentially-better-practice applications amongst NICUs, unmeasured biologic interactions, and obscured cultural-environmental contexts that all likely affect care. Triple Aim excellence, if even remotely possible, will necessitate scalable, evidence-based methodologies, pragmatism regarding inevitable trade-offs, and wise constrained-resource decisions. KEY POINTS: · The Triple Aim gold standard is elusive. There is no demonstration of sustained, large-scale success in healthcare and our quality improvement network has previously published benchmark extreme prematuritymorbidity improvements.. · Extreme prematurity outcomes illustrated as the Triple Aim show uneven results in relevant surrogate parameters and Triple Aim achievement, if even possible, will necessitate evidence-based methodologies that are scalable.. · Pragmatism, inevitable trade-offs, and wise constrained-resource decisions are required for Triple Aim success..
RESUMO
OBJECTIVE: This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. STUDY DESIGN: The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. RESULTS: Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15-74% across six sites) of the time. CONCLUSION: PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03019367. KEY POINTS: · Waiver of consent is when informed consent cannot be obtained prior to delivery.. · Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn.. · Delayed clamping means the umbilical cord is not clamped immediately after birth..
Assuntos
Doenças do Prematuro , Recém-Nascido Prematuro , Constrição , Feminino , Humanos , Lactente , Recém-Nascido , Consentimento Livre e Esclarecido , Gravidez , Cordão UmbilicalRESUMO
In the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required <10 days of intubation. However, in infants requiring intubation for ≥10 days, prolonged PDA exposure (≥11 days) was associated with an increased risk of moderate/severe BPD.
Assuntos
Displasia Broncopulmonar/etiologia , Permeabilidade do Canal Arterial/terapia , Intubação Intratraqueal/efeitos adversos , Intubação Intratraqueal/métodos , Respiração Artificial , Displasia Broncopulmonar/epidemiologia , Permeabilidade do Canal Arterial/complicações , Feminino , Humanos , Recém-Nascido , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de TempoRESUMO
The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.
Assuntos
Esquema de Medicação , Permeabilidade do Canal Arterial/tratamento farmacológico , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Displasia Broncopulmonar/complicações , Feminino , Humanos , Lactente Extremamente Prematuro , Recém-Nascido de Baixo Peso , Recém-Nascido , Doenças do Prematuro/terapia , Masculino , Idade Materna , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Risco , Resultado do TratamentoRESUMO
OBJECTIVE: To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. STUDY DESIGN: A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. RESULTS: At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). CONCLUSIONS: In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.
Assuntos
Acetaminofen/uso terapêutico , Tratamento Conservador , Inibidores de Ciclo-Oxigenase/uso terapêutico , Permeabilidade do Canal Arterial/terapia , Ibuprofeno/uso terapêutico , Indometacina/uso terapêutico , Pressão Positiva Contínua nas Vias Aéreas , Permeabilidade do Canal Arterial/classificação , Feminino , Idade Gestacional , Humanos , Lactente Extremamente Prematuro , Recém-Nascido , Masculino , Estudos Prospectivos , Método Simples-Cego , Resultado do TratamentoRESUMO
AIM: Continuous quality improvement has failed to consistently reduce morbidities in extremely low gestational age newborns 23-27 weeks. 10 Vermont Oxford Network NICUs describe a novel, sustained collaboration for progress. METHODS: We emphasised a) commitment to inter-NICU trust with face-to-face meetings, site visits, teleconferences, scrutiny of quality improvement methodology, b) transparent process and outcomes sharing, c) evidence-based formulation of an orchestrated testing matrix to select potentially better practices, d) family integration, e) benchmarking with a composite mortality-morbidity score (Benefit Metric). RESULTS: A total of 4709 infants, mean (SD) gestational age 25.8 (1.4) weeks, admitted to 10 NICUs 1.01.2010 to 12.31.2016. The orchestrated matrix offered 45 potentially better practices; NICUs implemented mean 29 (range 19-40). There was widespread adoption of delivery room, respiratory care and infection prevention practices, but no uniform pattern. Our Benefit Metric was significantly greater than the Vermont Oxford Network all seven years (p < 0.001). Six major morbidities decreased, two significantly (p < 0.05), mortality unchanged (14%). 34% of survivors had no morbidities, 35% just one. CONCLUSION: Cultivating trust, transparent outcomes sharing, and tailored, potentially better practice selection is associated with encouraging improvement in 23- to 27-week survival without morbidity. Our outcomes are objective but the optimal implementation pathway to sustain progress remains murky, reflective of NICUs as complex adaptive networks.
Assuntos
Unidades de Terapia Intensiva Neonatal/normas , Feminino , Humanos , Lactente , Mortalidade Infantil , Lactente Extremamente Prematuro , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Masculino , Melhoria de QualidadeRESUMO
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 , Avaliação de Resultados em Cuidados de Saúde , GravidezAssuntos
COVID-19/prevenção & controle , Custos de Cuidados de Saúde/ética , Alocação de Recursos para a Atenção à Saúde/ética , Lactente Extremamente Prematuro , Doenças do Prematuro/terapia , Terapia Intensiva Neonatal/ética , Justiça Social/ética , COVID-19/economia , COVID-19/epidemiologia , Tomada de Decisão Clínica/ética , Tomada de Decisão Clínica/métodos , Custos de Cuidados de Saúde/estatística & dados numéricos , Alocação de Recursos para a Atenção à Saúde/economia , Alocação de Recursos para a Atenção à Saúde/métodos , Humanos , Recém-Nascido , Doenças do Prematuro/economia , Terapia Intensiva Neonatal/economia , Terapia Intensiva Neonatal/estatística & dados numéricos , Cuidados Paliativos/economia , Cuidados Paliativos/ética , Pandemias , Qualidade de Vida , Justiça Social/economia , Valores Sociais , Estados Unidos/epidemiologiaRESUMO
Since the 1960s, the gestational age at which premature infants typically survive has decreased by approximately one week per decade [...].
RESUMO
Importance: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. Intervention: UCM and ECC. Main Outcomes and Measures: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Results: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940.
Assuntos
Clampeamento do Cordão Umbilical , Humanos , Feminino , Recém-Nascido , Masculino , Lactente , Clampeamento do Cordão Umbilical/métodos , Estudos Cross-Over , Cordão Umbilical , Hipóxia-Isquemia Encefálica/terapia , Pré-EscolarRESUMO
The United States has a highly sophisticated pediatric healthcare system and spends more than any other country per capita on children's healthcare. However, not all children have access to needed and affordable health care and the life expectancy and health outcomes of children in the country are worse than in any other industrialized nation. These nations typically offer universal healthcare for children as part of a robust recognition of a children's rights framework. In 1989 the United Nations adopted the Convention on the Rights of the Child that recognizes the right of the child to the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health. Currently the United States is the only United Nations member country that has not ratified the Convention on the Rights of the Child. This paper outlines the potential benefits of adopting a child rights approach based on the principles and provisions of the Convention on the Rights of the Child. The fact that countries who invest much less in healthcare compared to the United States can achieve better health outcomes provides the certainty that a solution is possible and within reach.
RESUMO
OBJECTIVE: Survival rates of extremely premature infants are rising, but changes in neurodevelopmental impairment (NDI) rates are unclear. Our objective was to perform a systematic review of intrainstitutional variability of NDI over time. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Ovid MEDLINE, Embase, PubMed, Cochrane Library and Google Scholar. STUDY SELECTION: Study eligibility: (1) at least two discrete cohorts of infants born <27 weeks' gestation or <1000 g birth weight, (2) one cohort born after 1990 and at least one subsequent cohort of similar gestational age, (3) all cohorts cared for within the same Neonatal Intensive Care Unit(s) (NICU) and (4) neurodevelopmental outcomes at 18-36 months corrected age. MAIN OUTCOME: Change in NDI rates. Quality, validity and bias were assessed using Grading of Recommendations, Assessment, Development, and Evaluation and Quality in Prognosis Studies guidelines. RESULTS: Of 203 publications, 15 were eligible, including 13 229 infants. At the first time point, average NDI rate across study groups weighted by sample size was 41.0% (95% CI 34.0% to 48.0%). The average change in NDI between time points was -3.3% (95% CI -8·8% to 2.2%). For each added week of gestation at birth, the rate of NDI declined by 9.7% (95% CI 6.2% to 13.3%). Most studies exhibited moderate-severe bias in at least one domain, especially attrition rates. CONCLUSIONS: When comparing discrete same-centre cohorts over time, there was no significant change in NDI rates in infants born <27 weeks' gestation or <1000 g. Higher survival rates unaccompanied by improvement in neurodevelopment highlight urgency for renewed focus on the causes of NDI and evidence-based strategies to reduce brain injury.
Assuntos
Lactente Extremamente Prematuro , Doenças do Prematuro , Recém-Nascido , Lactente , Humanos , Peso ao Nascer , Idade Gestacional , Prognóstico , Doenças do Prematuro/epidemiologiaRESUMO
Two hospitals noted increased newborn hyperbilirubinemia coinciding with an undisclosed total serum bilirubin (TSB) assay change. Clinicians rapidly applied quality improvement methodologies to ascertain increased jaundice evaluations, readmissions, and possible safety issues. Methods: In January 2020, 2 hospitals (A and B) transitioned to a new method of measuring TSB using a new clinical chemistry analyzer (Siemens Atellica CH), which measured TSB by vanadate oxidase assay instead of the previous diazo assay. Five affiliated hospitals (C-G) continued to utilize the diazo assay. This natural experiment led to a comparison of data across the 7 hospitals. We analyzed: (1) TSB levels, (2) hospital hyperbilirubinemia readmissions, and (3) paired TSB measurements comparing the diazo assay and vanadate oxidase method. Results: Compared to the 2019 baseline, Hospitals A and B had a significant increase in TSBs ≥17.0 mg/dl and TSBs ≥20 mg/dl in 2020; Hospitals C-G did not. Readmissions for phototherapy significantly increased in hospitals A and B in 2020 compared to 2019. Paired blood samples showed bias-elevated TSBs by vanadate assay compared to the diazo method. By 2021, the laboratory resumed processing TSB samples by diazo assay, and the frequency of elevated TSBs and hyperbilirubinemia readmissions returned to 2019 levels. Conclusions: Factitious TSB elevation related to an assay change significantly increased newborn hyperbilirubinemia evaluations and phototherapy readmissions. Imbedded quality improvement methodologies of careful structure, process, and outcomes review hastened resolution.