Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial.

BACKGROUND: Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. OBJECTIVE: The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. METHODS: This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised. RESULTS: Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. CONCLUSIONS: This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17943.

Efecto de la helonías dioica en la glicemia, consumo de alimentos y H2O y peso en ratas diabéticas y sanas / Effects of helonias dioica on serum glucose levels, weight, water and food ingestion in normal and diabetic rats

Se estudió en forma experimental el efecto de la helonías dioica como fármaco hipoglicemiante en 20 ratas de la cepa Wister con diabetes inducida. La diabetes se indujo con aloxano administrado por vía endovenosa femoral y en dosis de 40 mgr por kilogramo. Estos animales se compararon con un grupo control de 20 ratas. El estudio duró 28 días, controlándose diariamente glicemia y consumo de alimento y de agua. El control de peso lo realizó día de por medio, siempre la misma persona. Las ratas diabéticas tuvieron un mayor consumo de agua al compararlas con las ratas sanas. Las ratas diabéticas tuvieron un mayor consumo de agua al compararlas con las ratas sanas. Se demostró un nivel menor de glicemia en las ratas diabéticas en tratamiento con helonías que en las diabéticas, que sólo recibieron solución fisiológica. La helonías dioica podría tener un efecto en los niveles plasmáticos de glucosa, pero se requiere mayor investigación al respecto