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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
Death
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Time frame: Birth to 22-26 months corrected gestational age
Number of Participants With Neurodevelopmental Impairment
This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
Time frame: Birth to 22-26 months corrected gestational age
Number of Participants With Death or Neurodevelopmental Impairment
A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Time frame: Birth to 22-26 months corrected gestational age
Duration of Mechanical Ventilation
This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
Time frame: Birth to 60 days of life
Days to Full Feeds
The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.
Time frame: Birth to 60 days of life
Number of Participants With Need for Gastronomy Tube
This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No
Time frame: Birth to 60 days of life
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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
...and 8 more locations
Duration of Oxygen Requirement
This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
Time frame: Birth to 60 days of life
Number of Participants With Need for Home Oxygen
This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
Time frame: Birth to 60 days of life
Hospital Length of Stay
This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.
Time frame: Birth to 60 days of life
Number of Participants With Renal Insufficiency
This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment
Time frame: Birth to 60 days of life
Number of Participants With Necrotizing Enterocolitis
This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery
Time frame: Birth to 60 days of life
Number of Participants With Need for ECMO Therapy
This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.
Time frame: Birth to 60 days of life
Number of Participants With Inotrope Exposure
This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.
Inotrope Duration
This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.
Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.
Maximum Inotrope Dose
This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.
Time frame: From start of study drug administration (7 days) through 3 days post study drug administration.
Oxygenation Index
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.
Time frame: Birth to 60 days of life
Respiratory Severity
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.
Time frame: Birth to 60 days of life
Number of Participants With Fluid Boluses Given
This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.
Time frame: Birth to 60 days of life
Number of Boluses Given
The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Time frame: Birth to 60 days of life