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Dexamethasone Therapy in VLBW Infants at Risk of CLD (Dexamethasone)

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ClinicalTrials.gov Identifier: NCT00011362
Recruitment Status : Completed
First Posted : February 19, 2001
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Tracking Information
First Submitted Date  ICMJE February 15, 2001
First Posted Date  ICMJE February 19, 2001
Last Update Posted Date March 22, 2019
Study Start Date  ICMJE September 1992
Actual Primary Completion Date January 1994   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
Number of days from randomization to ventilator independence, defined as extubation not requiring reintubation, or extubation followed by elective reintubation for seven days or less so that the infant could undergo a surgical procedure [ Time Frame: At hospital discharge ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • Death before discharge from the hospital [ Time Frame: At hospital discharge ]
  • Duration of assisted ventilation [ Time Frame: At hospital discharge ]
  • Duration of supplemental oxygen therapy [ Time Frame: At hospital discharge ]
  • Duration of hospital stay [ Time Frame: At hospital discharge ]
  • Incidence of chronic lung disease [ Time Frame: At hospital discharge ]
  • Morbidity and mortality from respiratory causes during the first year [ Time Frame: 12 months of age ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone Therapy in VLBW Infants at Risk of CLD
Official Title  ICMJE Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD)
Brief Summary Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.
Detailed Description

Ventilator-dependent premature infants are often treated with dexamethasone. However, the optimal timing of therapy is unknown. We compared the benefits and hazards of initiating dexamethasone therapy at two weeks of age and at four weeks of age in 371 ventilator-dependent very-low-birth-weight infants (501 to 1500 grams) who had respiratory-index scores (mean airway pressure x the fraction of inspired oxygen) of greater than or equal 2.4 at two weeks of age. The primary outcome was the number of days from randomization to extubation not requiring reintubation (extubation score or death). The secondary outcomes were death before discharge from the hospital; the duration of assisted ventilation, supplementary oxygen therapy and hospital stay; the incidence of chronic lung disease (defined as the need for supplemental oxygen at 36 weeks postconceptional age by best obstetrical estimate) and rates of morbidity and mortality from respiratory causes during the first year. Additional secondary endpoints were hyperglycemia, hypertension, growth, bacteremia, necrotizing enterocolitis and upper GI bleeding.

The sample size of 370 was based on a 0.60 probability that the extubation score of late treatment was greater than early treatment, a 5% two-sided type 1 error, 85% power, and 10% treatment noncompliance.

Infants were randomized to either receive dexamethasone for two weeks followed by saline placebo for two weeks, or saline placebo for two weeks followed by either dexamethasone or additional placebo for two weeks (if they still met entry criteria). Dexamethasone was given at a dose of 0.25 mg per kilogram of body weight twice daily intravenously or orally for five days, and the dose then tapered.

The median time to ventilator independence was 36 days in the dexamethasone-placebo group and 37 days in the placebo-dexamethasone group. The incidences of chronic lung disease (defined as the need for oxygen supplementation at 36 weeks postconceptional age) were 66 percent and 67 percent, respectively. Dexamethasone was associated with an increased incidence of nosocomial bacteremia (relative risk, 1.5; 95 percent confidence interval, 1.1 to 2.1) and hyperglycemia (relative risk, 1.9; 95 percent confidence interval, 1.2 to 3.0) in the dexamethasone-placebo group, elevated blood pressure (relative risk, 2.9; 95 percent confidence interval, 1.2 to 6.9) in the placebo-dexamethasone group, and diminished weight gain and head growth (P less than 0.001) in both groups. Treatment of ventilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four weeks of age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Bronchopulmonary Dysplasia
Intervention  ICMJE
  • Drug: Dexamethasone Early
    Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.
  • Drug: Dexamethasone Late
    Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was >=2.4 on treatment day 14, or an additional two weeks of saline
Study Arms  ICMJE
  • Active Comparator: Dexamethasone
    Dexamethasone
    Interventions:
    • Drug: Dexamethasone Early
    • Drug: Dexamethasone Late
  • Placebo Comparator: Placebo
    Saline
    Interventions:
    • Drug: Dexamethasone Early
    • Drug: Dexamethasone Late
Publications *

*   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: June 23, 2005)
371
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1994
Actual Primary Completion Date January 1994   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • 501 to 1500 grams
  • 13 to 15 days old
  • Respiratory-index score of greater than or equal to 2.4 that had been increasing or minimally decreasing during the previous 48 hours or a score of greater than or equal to 4.0 even if there had been improvement during the preceding 48 hours

Exclusion criteria:

  • Received glucocorticoid treatment after birth
  • Had evidence or suspicious signs of sepsis as judged by the treating physician
  • Major congenital anomaly of the cardiovascular, pulmonary, or central nervous system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 15 Days   (Child)
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 NCT00011362
Other Study ID Numbers  ICMJE NICHD-NRN-0005
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U01HD019897 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lu-Ann Papile/ Lead Principal Investigator, University of New Mexico
Study Sponsor  ICMJE NICHD Neonatal Research Network
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: Jon E. Tyson, MD MPH University of Texas Southwestern Medical Center
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Sheldon B. Korones, MD University of Tennessee Health Science Center
Principal Investigator: James A. Lemons, MD Indiana University School of Medicine
Principal Investigator: Avroy A. Fanaroff, MD Rainbow Babies & Children's Hospital, Case Western Reserve University
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: William Oh, MD Women & Infants' Hospital, Brown University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
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