Hydrocortisone for Term Hypotension
- Conditions
- Infant, Newborn, DiseasesCardiovascular Insufficiency
- Interventions
- Drug: Placebo
- Registration Number
- NCT01954056
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Saline placebo Hydrocortisone Hydrocortisone hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
- Primary Outcome Measures
Name Time Method Number of Participants With Neurodevelopmental Impairment Birth to 22-26 months corrected gestational age 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.
Death Birth to 22-26 months corrected gestational age This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Number of Participants With Death or Neurodevelopmental Impairment Birth to 22-26 months corrected gestational age A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
- Secondary Outcome Measures
Name Time Method Number of Participants With Need for Gastronomy Tube Birth to 60 days of life 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
Number of Participants With Necrotizing Enterocolitis Birth to 60 days of life 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
Maximum Inotrope Dose From start of study drug administration (7 days) through 3 days post study drug administration. 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.
Duration of Mechanical Ventilation Birth to 60 days of life This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
Inotrope Duration 24 hours prior to study drug administration through 3 days post study drug administration. 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.
Days to Full Feeds Birth to 60 days of life 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.
Duration of Oxygen Requirement Birth to 60 days of life This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
Number of Participants With Need for Home Oxygen Birth to 60 days of life This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
Number of Participants With Renal Insufficiency Birth to 60 days of life 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
Oxygenation Index Birth to 60 days of life 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.
Number of Participants With Fluid Boluses Given Birth to 60 days of life 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.
Number of Boluses Given Birth to 60 days of life The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Hospital Length of Stay Birth to 60 days of life 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.
Number of Participants With Need for ECMO Therapy Birth to 60 days of life 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.
Number of Participants With Inotrope Exposure 24 hours prior to study drug administration through 3 days post study drug administration. This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
Respiratory Severity Birth to 60 days of life 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.
Trial Locations
- Locations (18)
Case Western Reserve University
đŸ‡ºđŸ‡¸Cleveland, Ohio, United States
Research Institute at Nationwide Children's Hospital
đŸ‡ºđŸ‡¸Columbus, Ohio, United States
University of Texas Health Science Center at Houston
đŸ‡ºđŸ‡¸Houston, Texas, United States
Stanford University
đŸ‡ºđŸ‡¸Palo Alto, California, United States
University of Texas Southwestern Medical Center at Dallas
đŸ‡ºđŸ‡¸Dallas, Texas, United States
University of Pennsylvania
đŸ‡ºđŸ‡¸Philadelphia, Pennsylvania, United States
Children's Mercy Hospital
đŸ‡ºđŸ‡¸Kansas City, Missouri, United States
RTI International
đŸ‡ºđŸ‡¸Durham, North Carolina, United States
Duke University
đŸ‡ºđŸ‡¸Durham, North Carolina, United States
Cincinnati Children's Medical Center
đŸ‡ºđŸ‡¸Cincinnati, Ohio, United States
University of Alabama at Birmingham
đŸ‡ºđŸ‡¸Birmingham, Alabama, United States
University of California - Los Angeles
đŸ‡ºđŸ‡¸Los Angeles, California, United States
Emory University
đŸ‡ºđŸ‡¸Atlanta, Georgia, United States
Indiana University
đŸ‡ºđŸ‡¸Indianapolis, Indiana, United States
University of Iowa
đŸ‡ºđŸ‡¸Iowa City, Iowa, United States
Wayne State University
đŸ‡ºđŸ‡¸Detroit, Michigan, United States
University of New Mexico
đŸ‡ºđŸ‡¸Albuquerque, New Mexico, United States
University of Rochester
đŸ‡ºđŸ‡¸Rochester, New York, United States