Hydrocortisone for Term Hypotension

Infant, Newborn, Diseases Clinical Trial

Official title:

Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954056
• Other study ID #: NICHD-NRN-0052
• Secondary ID: U10HD021364U10HD
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Insufficiency
• Infant, Newborn, Diseases

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

External Links

•   NICHD Neonatal Research Network site
•   NICHD Pregnancy & Perinatology Branch