Hydrocortisone treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
Study ID: STU 042014-034
Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age. Cardiovascular insufficiency occurs when there is inadequate blood flow to meet the needs of metabolism and often presents as low blood pressure, poor capillary refill, low urine output acidosis. Critically ill infants with these signs often receive fluid boluses or inotropes and, increasingly, steroids to improve systemic blood flow. Yet, for the majority of infants, the etiology of cardiovascular insufficiency in the first few days of life is unclear. Emerging evidence suggests that a frequent etiology of cardiovascular instability or insufficiency in ill adult and some pediatric populations may be relative adrenal insufficiency, an inadequate cortisol response to acute stress or illness. Glucocorticoid treatment in some critically ill populations results in decreased mortality and morbidity in some studies. Small studies have documented inappropriately low cortisol values in conjunction with cardiovascular dysfunction in critically ill term and late preterm infants. In addition, we have shown that such infant have low endogenous concentrations of adrenocorticotropic hormone (ACTH) and have normal responses to exogenous ACTH. Although small case series and retrospective studies have documented improved cardiovascular stability following glucocorticoid treatment in hypotensive term infants, no randomized controlled trials (RCTs) have evaluated the effects of glucocorticoids on cardiovascular function, short-term outcomes, or long-term neurodevelopment in critically ill term or late preterm infants with cardiovascular insufficiency. It is urgent that research is advanced in this area because, despite the lack of well-designed studies, there is an increasing use of glucocorticoid therapy for hypotension in this population. This study aims to determine, through optimal study design, the efficacy and consequences of glucocorticoid therapy in critically ill term and late preterm infants.
- gestational age greater than or equal to 34 weeks - admitted to the center NICU before 48 hours of age - intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age - infant must be intubated and mechanically ventilated at the time of screening and consent