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Hydrocortisone for Term Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01954056
Recruitment Status : Completed
First Posted : October 1, 2013
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE October 1, 2013
Results First Submitted Date  ICMJE January 18, 2019
Results First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE June 19, 2014
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Death [ Time Frame: 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 Neurodevelopmental Impairment [ Time Frame: 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.
  • Number of Participants With Death or Neurodevelopmental Impairment [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Death or neurodevelopmental impairment [ Time Frame: Birth to 22-26 months corrected gestational age ]
Change History Complete list of historical versions of study NCT01954056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Duration of Mechanical Ventilation [ Time Frame: 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.
  • Days to Full Feeds [ Time Frame: 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.
  • Number of Participants With Need for Gastronomy Tube [ Time Frame: 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
  • Duration of Oxygen Requirement [ Time Frame: 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 [ Time Frame: 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.
  • Hospital Length of Stay [ Time Frame: 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 Renal Insufficiency [ Time Frame: 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
  • Number of Participants With Necrotizing Enterocolitis [ Time Frame: 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
  • Number of Participants With Need for ECMO Therapy [ Time Frame: 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 [ Time Frame: 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.
  • Inotrope Duration [ Time Frame: 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.
  • Maximum Inotrope Dose [ Time Frame: 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.
  • Oxygenation Index [ Time Frame: 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.
  • Respiratory Severity [ Time Frame: 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.
  • Number of Participants With Fluid Boluses Given [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Duration of Mechanical Ventilation [ Time Frame: Birth to 60 days of life ]
    Number of days of laryngeal intubation and mechanical ventilation
  • Days to Full Feeds [ Time Frame: Birth to 60 days of life ]
    Day of age when enteral feeds ≥ 120 cc/kg/day (continuous)
  • Need for gastrostomy tube [ Time Frame: Birth to 60 days of life ]
  • Duration of Oxygen Requirement [ Time Frame: Birth to 60 days of life ]
    Number of days on oxygen while in hospital (continuous)
  • Need for home oxygen [ Time Frame: Birth to 60 days of life ]
    Infants discharged home on oxygen
  • Hospital Length of Stay [ Time Frame: Birth to 60 days of life ]
  • Renal insufficiency [ Time Frame: Birth to 60 days of life ]
    Presence of creatinine > 2.0 in first 7 days of age (dichotomous)
  • Necrotizing enterocolitis [ Time Frame: Birth to 60 days of life ]
    Presence of NEC stage II or greater at any time prior to discharge (dichotomous)
  • Need for ECMO Therapy [ Time Frame: Birth to 60 days of life ]
  • Death [ Time Frame: Birth to 22-26 months corrected age ]
  • Neurodevelopmental Impairment [ Time Frame: Birth to 22-26 month corrected age ]
    The presence of a cognitive, language or motor score less than 1 SD below the mean on the Bayley Scales of Infant Development III (BSID), gross motor functional (GMF) level ≥1, visual impairment or blindness in any eye, hearing impairment, or seizure disorder.
  • Severity of illness [ Time Frame: Birth to 60 days of life ]
    The calculated oxygenation index and respiratory severity score during study drug administration
  • Inotrope exposure [ Time Frame: Birth to 60 days of life ]
    Presence of inotrope and dose exposure
  • Fluid bolus exposure [ Time Frame: Birth to 60 days of life ]
    Presence and dose of fluid exposure during study drug administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydrocortisone for Term Hypotension
Official Title  ICMJE Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn, Diseases
  • Cardiovascular Insufficiency
Intervention  ICMJE
  • 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

  • Drug: 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

Study Arms  ICMJE
  • Active Comparator: Hydrocortisone
    hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
    Intervention: Drug: Hydrocortisone
  • Placebo Comparator: Placebo
    Saline placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
646
Actual Study Completion Date  ICMJE March 20, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 34 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01954056
Other Study ID Numbers  ICMJE NICHD-NRN-0052
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NICHD Neonatal Research Network
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE
  • National Center for Research Resources (NCRR)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Michele C Walsh, MD Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Abbot R Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Ron N Goldberg, MD Duke University
Principal Investigator: Barbara J Stoll, MD Emory University
Principal Investigator: Brenda B Poindexter, MD, MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Kurt Schibler, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
Principal Investigator: Edward F Bell, MD Michele C Walsh, MD Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Seetha Shankaran, MD Study Principal Investigator Wayne State University Abbot R Laptook, MD Study Principal Investigator Brown Un
Study Chair: Erika Fernandez, MD University of New Mexico
Principal Investigator: Myra Wycoff, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston
Principal Investigator: Barbara Schmidt, MD University of Pennsylvania
Principal Investigator: Carl T D'Angio, MD University of Rochester
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Leif Nelin, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: William Truog, MD Children's Mercy Hospital Kansas City
PRS Account NICHD Neonatal Research Network
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP