RESUMEN
Importance: Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations. Objective: To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants. Design, Setting, and Participants: Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes. Interventions: The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H2O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211). Main Outcome and Measures: The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours. Results: Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, -3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups. Conclusions and Relevance: Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions. Trial Registration: clinicaltrials.gov Identifier: NCT02139800.
Asunto(s)
Asfixia Neonatal/terapia , Recien Nacido Extremadamente Prematuro , Ventilación con Presión Positiva Intermitente , Respiración con Presión Positiva/métodos , Asfixia Neonatal/fisiopatología , Bradicardia/terapia , Displasia Broncopulmonar/etiología , Femenino , Capacidad Residual Funcional , Edad Gestacional , Frecuencia Cardíaca , Mortalidad Hospitalaria , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Masculino , Respiración con Presión Positiva/efectos adversos , Resucitación/métodosRESUMEN
Introduction: In 2017, approximately 295,000 women died during and immediately following pregnancy and childbirth worldwide, with 94% of these deaths occurring in low-resource settings. The Dominican Republic (DR) exhibits one of the highest maternal mortality ratios in the region of Latin America and the Caribbean despite the fact that 99% of registered births in the country are reportedly attended by a skilled birth attendant. This paradox implies that programs to support healthcare worker knowledge and skills improvement are vital to improving maternal health outcomes in the DR. Helping Mothers Survive (HMS) is a provider training program developed by Jhpiego and global partners. The goal of HMS is to combat maternal mortality by contributing to quality improvement efforts that reinforce maternal health skills of local healthcare workers. Methods: An international, multisectoral group of stakeholders collaborated in the implementation of two HMS curricula, Bleeding After Birth (BAB) and pre-eclampsia & eclampsia (PE&E). Demographic information as well as pre- and post-training knowledge scores were recorded for each participant. Knowledge score improvement was assessed in order to support effectiveness of the program on knowledge acquisition of healthcare workers. Results: Three hundred and twenty healthcare workers participated in the HMS training workshops between October 2016-August 2020. Of the 320 participants, 132 were trained as master trainers. The majority of participants identified as attending physicians, followed by residents/interns, nurses, students, and "other." A significant improvement in knowledge scores was observed for both the BAB and PE&E curricula, with a 21.24 and 30.25% change in average score (pre- to post-test), respectively. In response to COVID-19 pandemic restrictions, flexibility of the local team led to a PE&E virtual training pilot workshop in August 2020. Discussion/Conclusions: Simulation-based training improved the knowledge levels of healthcare workers for both HMS curricula. These results suggest that simulation-based workshops have an impact on knowledge acquisition and skills of healthcare workers immediately following training. For the PE&E curriculum, no significant difference in knowledge acquisition was observed between in-person and virtual training sessions. The ongoing pandemic poses challenges to program implementation; however, these preliminary results provide evidence that conducting virtual workshops may be a viable alternative to in-person training.
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COVID-19 , Madres , República Dominicana/epidemiología , Femenino , Humanos , América Latina , Pandemias , Embarazo , Evaluación de Programas y Proyectos de Salud , SARS-CoV-2RESUMEN
BACKGROUND: Neonatal mortality accounts for 45% of under-5 mortality worldwide, with 98% of newborn deaths occurring in developing countries. The Dominican Republic (DR) demonstrates one of the highest neonatal mortality rates in Latin America despite broad access to care. Strategies to support professional capacity building and strengthen the local health care system are needed to improve neonatal outcomes in the DR. RATIONALE: Helping babies breathe (HBB) and essential care for every baby (ECEB) are evidence-based newborn resuscitation and essential care training programs that have been shown to improve providers' confidence, knowledge, and clinical skills. Lack of professional support and infrequent resuscitation skills practice are commonly cited as barriers to skill retention after HBB training, while establishment of program mentoring and regular skills refreshers are associated with retention of clinical knowledge and skills and improved clinical performance and outcomes. Global partnerships to facilitate implementation of a comprehensive newborn resuscitation and essential care training program with ongoing clinical and program mentorship in the DR should have a lasting impact on workforce capacity, quality of care, and clinical outcomes. METHODS: A multidisciplinary, international group of clinicians partnered with the Ministry of Health to design and implement a comprehensive newborn health initiative in the DR. A train-the-trainer model structured the regional rollout of a combined HBB/ECEB program with integrated quality improvement (QI) initiatives and systems for ongoing program monitoring, reinforcement, and mentorship. Cognitive, affective, behavioral, and clinical outcomes are being measured. RESULTS: Seventeen local champions representing six hospitals participated in the HBB/ECEB master trainer course and design of a QI tool for site-specific clinical performance monitoring. One hundred seventy-eight and 171 providers participated in HBB and ECEB courses, respectively, at pilot sites during the following year. Participants completed prior training need assessment, pre-/post-knowledge assessments and course evaluations. Program mentorship and monitoring of continuing education and clinical performance are ongoing. The Ministry of Health has assumed responsibility for program sustainability and current scale-up, including integration of maternal resuscitation training. CONCLUSION: International partnerships facilitated the collaborative implementation of scalable, locally sustainable newborn resuscitation and essential care training in the DR, mobilizing local resources and empowering the workforce to capably pursue improved care of an exceedingly vulnerable community.
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BACKGROUND: Self-limited respiratory distress is a common neonatal respiratory morbidity for which effective treatments are lacking. Supportive care with non-invasive respiratory support is the norm. Animal models suggest that intrapartum exposure to group B Streptococcus (GBS) may cause mild pulmonary hypertension in the neonate, resulting in self-resolving respiratory distress. Treatments for pulmonary hypertension are currently not provided to neonates with self-limited respiratory distress empirically. OBJECTIVES: This study examines the hypothesis that the incidence and severity of self-limited respiratory distress are altered by intrapartum exposure to GBS and antibiotic prophylaxis (IAP) in a human population. METHODS: This is a 10-year single-center cohort study of retrospective data of late preterm and term neonates diagnosed with self-limited respiratory distress. Multiple logistic models were fitted to examine associations between exposure to GBS and IAP, and markers of self-limited respiratory distress severity. Additional linear regression models were fitted to examine the association between exposure to GBS and IAP, and duration of respiratory support for self-limited respiratory distress. Finally, crude and gestational age-adjusted incidence of self-limited respiratory distress among GBS-exposed and -unexposed infants, as well as the odds of self-limited respiratory distress based on GBS exposure were calculated. RESULTS: 584 neonates met study criteria. Neither GBS exposure nor IAP exposure was associated with severity of self-limited respiratory distress in multiple models. Crude and adjusted incidence of self-limited respiratory distress among neonates did not differ by GBS exposure history. CONCLUSIONS: Although animal studies indicate that GBS-mediated pulmonary hypertension may contribute to self-limited respiratory distress, neither exposure to GBS nor IAP was associated with an increased severity or incidence of self-limited respiratory distress in our human study population. Treatments for pulmonary hypertension are unlikely to speed symptom resolution for patients with self-limited respiratory distress.
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Recién Nacido , Recien Nacido Prematuro , Insuficiencia Respiratoria/microbiología , Infecciones Estreptocócicas/fisiopatología , Streptococcus agalactiae/aislamiento & purificación , Profilaxis Antibiótica , Estudios de Cohortes , Femenino , Humanos , Incidencia , Modelos Logísticos , Embarazo , Estudios Retrospectivos , Infecciones Estreptocócicas/microbiologíaRESUMEN
BACKGROUND: Initiation of empiric antibiotic treatment for possible early-onset sepsis is recommended for late preterm and term neonates with respiratory distress. There is no evidence base to this approach. OBJECTIVES: To determine the incidence of adverse infectious events in neonates with transient tachypnea of the newborn (TTN) managed with a risk-factor-based restrictive antibiotic use policy. METHODS: This is a single institution retrospective cohort study of neonates with primary diagnosis of TTN between 2004 and 2010. The relationship between antibiotic exposure and infectious outcomes during the neonatal hospitalization was evaluated. An infectious outcome was defined as pneumonia, bacteremia, clinical sepsis, or death. Analysis included t test, χ(2) test, and analysis of variance as appropriate. RESULTS: 745 neonates with TTN met inclusion criteria. None of the 494 antibiotic-naive infants, and 212 of the 251 antibiotic-exposed infants had identifiable risk factors for sepsis. No infectious outcomes occurred in infants who did not receive antibiotics. Eight neonates with TTN received full antibiotic treatment for early-onset sepsis. Each was appropriately identified for early receipt of antibiotics based on historical or clinical risk factors for early-onset sepsis. CONCLUSIONS: This study suggests that empiric postnatal antibiotic treatment may not be warranted for late preterm and term infants with TTN in the absence of specific infectious risk factors.