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 |
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.
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.
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
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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7000 Fannin St
Houston, Texas 77030
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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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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