View clinical trials related to Newborn Morbidity.
Filter by:Background (brief): 1. Burden: Maternal and neonatal mortality continue to be a serious public health problem in Bangladesh. Facility-based healthcare services reduce the probability of preventable causes of maternal and neonatal death. Community clinics (CCs) are located closer to the community than other healthcare facilities are. However, only 2.8% of all CCs are ready to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide delivery services. Despite the wide acceptance of midwifery care for ANC and delivery services, they are posted only up to the Upazila Health Complexes and at selected Union Health and Family Welfare Centers. 2. Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal vaginal delivery, and postnatal care (PNC) services can be increased if midwives are assigned to CCs to provide these services. 3. Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted up to union-level facilities, and the Government of Bangladesh has a strategic plan to enable selective community clinics for normal delivery services in addition to antenatal and postnatal care. Hypothesis (if any): N/A Objectives: This study aims to assess the feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of introducing Midwifery-embodied Community Clinic (MCC) model in selected community clinics of Bangladesh. Methods: We will implement a Midwifery-embodied Community Clinic (MCC) model in two CCs of the Baliakandi sub-district of Rajbari district. Trained midwives will provide ANC, select low-risk pregnant women, conduct their normal deliveries, and provide PNC services in CCs, while the CHCP will provide essential newborn care during NVD. High-risk mothers will be referred to the upper level of healthcare facilities for managment. In addition, counselling services will be provided to mothers by the Health Assistants and Family Welfare Assistants during their domiciliary visits. Transport services using the ambulances of the Upazila Health Complex will be integrated into the model to transport patients to the CCs and upper-level healthcare facilities in case of emergencies. Outcome measures/variables: The outcome measures will be feasibility, adoption, acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of the MCC model.
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach. The main question it aims to answer are: - Develop a model that can predict the occurrence of AKI in infants admitted to the NICU; - Identify the drug or combination of drugs associated with an increased risk of AKI. The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.
Abstract Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way. Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used. Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.
The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.