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Hydrocortisone for Term Hypotension
Recruiting
I'm InterestedTrial ID: NCT01954056
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
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
Intervention(s):
drug: Hydrocortisone
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P. Van Meurs, MD
650-723-5711