Hydrocortisone for Term Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01954056
First received: September 26, 2013
Last updated: October 28, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Infant, Newborn
Infant, Cardiovascular Insufficiency
Drug: Hydrocortisone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Death or neurodevelopmental impairment [ Time Frame: Birth to 22-26 months corrected gestational age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Number of days of laryngeal intubation and mechanical ventilation

  • Days to full feeds [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Day of age when enteral feeds ≥ 120 cc/kg/day (continuous)

  • Need for gastrostomy tube [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
  • Duration of oxygen requirement [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Number of days on oxygen while in hospital (continuous)

  • Need for home oxygen [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Infants discharged home on oxygen

  • Hospital length of stay [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
  • Renal insufficiency [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Presence of creatinine > 2.0 in first 7 days of age (dichotomous)

  • Necrotizing enterocolitis [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: Birth to 22-26 months corrected age ] [ Designated as safety issue: Yes ]
  • Neurodevelopmental Impairment [ Time Frame: Birth to 22-26 month corrected age ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The calculated oxygenation index and respiratory severity score during study drug administration

  • Inotrope exposure [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Presence of inotrope and dose exposure

  • Fluid bolus exposure [ Time Frame: Birth to 60 days of life ] [ Designated as safety issue: Yes ]
    Presence and dose of fluid exposure during study drug administration


Estimated Enrollment: 646
Study Start Date: July 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 11 doses (2.75 days) 0.5 mg/kg q 12 hours x 4 doses (2 days) 0.5 mg/kg q day x 2 doses (2 days)

Placebo Comparator: Placebo
Saline placebo
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 11 doses (2.75 days) 0.5 mg/kg q 12 hours x 4 doses (2 days) 0.5 mg/kg q day x 2 doses (2 days)


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.

  Eligibility

Ages Eligible for Study:   34 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954056

Contacts
Contact: Erika Fernandez, MD 505-272-0180
Contact: Rosemary D Higgins, MD 301-496-5575

Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD    205-934-4680      
Principal Investigator: Waldemar A. Carlo, MD         
United States, California
University of California - Los Angeles Not yet recruiting
Los Angeles, California, United States, 90025
Contact: Uday Devaskar, MD    310-825-9314      
Principal Investigator: Uday Devaskar, MD         
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD    650-723-5711    vanmeurs@leland.stanford.edu   
Contact: M. Bethany Ball, BS CCRC    (650) 725-8342    mbball@stanford.edu   
Principal Investigator: Krisa P. Van Meurs, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Barbara J. Stoll, MD    404-727-2456      
Principal Investigator: Barbara J. Stoll, MD         
United States, Indiana
Indiana University Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brenda B. Poindexter, MD MS    317-274-4768      
Principal Investigator: Brenda B. Poindexter, MD MS         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F. Bell, MD    319-356-4006      
Principal Investigator: Edward F. Bell, MD         
United States, Michigan
Wayne State University Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Seetha Shankaran, MD    313-580-1436      
Principal Investigator: Seetha Shankaran, MD         
United States, Missouri
Children's Mercy Hospital Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: William Truog, MD    816-234-3592      
Principal Investigator: William Truog, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Erika Fernandez, MD    505-272-0180      
Principal Investigator: Kristi L. Watterberg, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD    585-273-4911      
Principal Investigator: Carl T D'Angio, MD         
United States, North Carolina
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Ronald N. Goldberg, MD    919-681-6024      
Principal Investigator: Ronald N. Goldberg, MD         
Sub-Investigator: C. Michael Cotten, MD MHS         
United States, Ohio
Cincinnati Children's Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kurt Schibler, MD    513-636-3972      
Principal Investigator: Kurt Schibler, MD         
Case Western Reserve University Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS    216-844-3387      
Principal Investigator: Michele C. Walsh, MD MS         
Research Institute at Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD    614-355-6724      
Principal Investigator: Leif Nelin, MD         
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island Not yet recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot R. Laptook, MD    401-274-1122 ext 43200      
Principal Investigator: Abbot R. Laptook, MD         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Myra Wyckoff, MD    214-648-3923      
Principal Investigator: Myra Wycoff, MD         
University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Kathleen A. Kennedy, MD MPH    713-500-6708      
Principal Investigator: Kathleen A. Kennedy, MD MPH         
Sub-Investigator: Jon E. Tyson, MD MPH         
Sponsors and Collaborators
Investigators
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 Goldbert, 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 Cincinnati Children's Medical Center
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 Truod, MD Children's Mercy Hospital-Kansas City, MO
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01954056     History of Changes
Other Study ID Numbers: NICHD-NRN-0052, U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880, U10HD034216, U10HD021373, U10HD040492, U10HD053109, U10HD040461, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284, U10HD036790
Study First Received: September 26, 2013
Last Updated: October 28, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Mechanical ventilation
Intubation
Neurodevelopmental impairment

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014