Hydrocortisone for Term Hypotension

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Trial ID: NCT01954056

Age - 34 Weeks-N/A Condition - Neonatal and Developmental Medicine Gender - All Accepting Healthy Volunteers - No

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

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Intervention(s):

drug: Hydrocortisone

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa P. Van Meurs, MD
650-723-5711

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