Dexamethasone Therapy in VLBW Infants at Risk of CLD

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Brief Title

Dexamethasone Therapy in VLBW Infants at Risk of CLD

Official Title

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Death before discharge from the hospital

Condition

Infant, Newborn

Intervention

Dexamethasone Early

Study Arms / Comparison Groups

 Dexamethasone
Description:  Dexamethasone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

371

Start Date

September 1992

Completion Date

April 1994

Primary Completion Date

January 1994

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 15 Days

Accepts Healthy Volunteers

No

Contacts

Lu-Ann Papile, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00011362

Organization ID

NICHD-NRN-0005

Secondary IDs

U10HD027881


Study Sponsor

NICHD Neonatal Research Network

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

Lu-Ann Papile, MD, Principal Investigator, University of New Mexico


Verification Date

March 2019