Hydrocortisone for Term Hypotension



Status:Completed
Healthy:No
Age Range:Any
Updated:4/4/2019
Start Date:June 19, 2014
End Date:March 20, 2018

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Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial

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.

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.

This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial
within the Neonatal Research Network (NRN). 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.

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
We found this trial at
18
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Cincinnati, Ohio 45267
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Cincinnati, OH
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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Columbus, OH
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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