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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01954056
Other study ID # NICHD-NRN-0052
Secondary ID U10HD021364U10HD
Status Completed
Phase Phase 3
First received
Last updated
Start date June 19, 2014
Est. completion date March 20, 2018

Study information

Verified date July 2021
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 12
Est. completion date March 20, 2018
Est. primary completion date March 20, 2018
Accepts healthy volunteers No
Gender All
Age group 34 Weeks and older
Eligibility 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

Study Design


Intervention

Drug:
Hydrocortisone
• 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
Placebo
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

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
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 Texas Southwestern Medical Center at Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States Duke University Durham North Carolina
United States RTI International Durham North Carolina
United States University of Texas Health Science Center at Houston Houston Texas
United States Indiana University Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States Children's Mercy Hospital Kansas City Missouri
United States University of California - Los Angeles Los Angeles California
United States Stanford University Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Rochester Rochester New York

Sponsors (3)

Lead Sponsor Collaborator
NICHD Neonatal Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No. Birth to 22-26 months corrected gestational age
Primary 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. Birth to 22-26 months corrected gestational age
Primary 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. Birth to 22-26 months corrected gestational age
Secondary 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. Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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 Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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 Birth to 60 days of life
Secondary 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 Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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. 24 hours prior to study drug administration through 3 days post study drug administration.
Secondary 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. 24 hours prior to study drug administration through 3 days post study drug administration.
Secondary 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. From start of study drug administration (7 days) through 3 days post study drug administration.
Secondary 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. Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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. Birth to 60 days of life
Secondary 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 Birth to 60 days of life
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