Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

Background: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. Methods/Design: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. Discussion: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight.Instituto Multidisciplinario de Biología Celula

Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

BACKGROUND: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. METHODS/DESIGN: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. DISCUSSION: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight

Biofeedback-Assisted Resilience Training for Traumatic and Operational Stress: Preliminary Analysis of a Self-Delivered Digital Health Methodology

Background: Psychological resilience is critical to minimize the health effects of traumatic events. Trauma may induce a chronic state of hyperarousal, resulting in problems such as anxiety, insomnia, or posttraumatic stress disorder. Mind-body practices, such as relaxation breathing and mindfulness meditation, help to reduce arousal and may reduce the likelihood of such psychological distress. To better understand resilience-building practices, we are conducting the Biofeedback-Assisted Resilience Training (BART) study to evaluate whether the practice of slow, paced breathing with or without heart rate variability biofeedback can be effectively learned via a smartphone app to enhance psychological resilience. Objective: Our objective was to conduct a limited, interim review of user interactions and study data on use of the BART resilience training app and demonstrate analyses of real-time sensor-streaming data. Methods: We developed the BART app to provide paced breathing resilience training, with or without heart rate variability biofeedback, via a self-managed 6-week protocol. The app receives streaming data from a Bluetooth-linked heart rate sensor and displays heart rate variability biofeedback to indicate movement between calmer and stressful states. To evaluate the app, a population of military personnel, veterans, and civilian first responders used the app for 6 weeks of resilience training. We analyzed app usage and heart rate variability measures during rest, cognitive stress, and paced breathing. Currently released for the BART research study, the BART app is being used to collect self-reported survey and heart rate sensor data for comparative evaluation of paced breathing relaxation training with and without heart rate variability biofeedback. Results: To date, we have analyzed the results of 328 participants who began using the BART app for 6 weeks of stress relaxation training via a self-managed protocol. Of these, 207 (63.1%) followed the app-directed procedures and completed the training regimen. Our review of adherence to protocol and app-calculated heart rate variability measures indicated that the BART app acquired high-quality data for evaluating self-managed stress relaxation training programs. Conclusions: The BART app acquired high-quality data for studying changes in psychophysiological stress according to mind-body activity states, including conditions of rest, cognitive stress, and slow, paced breathing