Hydrocortisone for Term Hypotension
Trial ID or NCT#
NCT01954056
Status
RECRUITING
Purpose
This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Official Title
Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
Eligibility Criteria
Ages Eligible for Study: Older than 34 Weeks
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Gestational age greater than or equal to 34 weeks at birth - Admitted to the center NICU by 48 hours of age - Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age
Exclusion Criteria:
- - Receiving ECMO - Intubated for the sole purpose of anticipated surgery or airway anomalies - Treatment will be limited based on poor prognosis - Receiving dexamethasone or hydrocortisone - Receiving ibuprofen or indomethacin - Congenital heart disease - Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax - Pituitary hypoplasia or congenital adrenal hyperplasia - Any chromosomal disorder - Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile - Initiation of whole body cooling for moderate or severe neonatal encephalopathy - Brain disorders or any other known structural abnormality - Major anomalies
Contact us to find out if this trial is right for you.
Contact
Krisa P. Van Meurs, MD
650-723-5711
View on ClinicalTrials.gov
