Hydrocortisone for Term Hypotension

Completed · Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Diseases, Cardiovascular Insufficiency

In brief

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.

Key facts

Study ID

NCT01954056

Run by

NICHD Neonatal Research Network

People needed

12

Starts

2014-06-19

Expected to finish

2018-03-20

Last updated by the study team

2021-07-06

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Wayne State University — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Rochester — Rochester, New York, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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