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A Trial of Two Steroid Treatments in Premature Infants
This study has been completed.
First Received: February 15, 2001   Last Updated: February 21, 2007   History of Changes
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00011362
  Purpose

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.


Condition Intervention Phase
Infant, Low Birth Weight
Respiratory Distress Syndrome
Respiratory Insufficiency
Drug: Dexamethasone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Multicenter Trial of Two Dexamethasone Regimens in Ventilator-Dependent Premature Infants.

Resource links provided by NLM:


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

Estimated Enrollment: 371
Study Start Date: September 1992
Estimated Study Completion Date: July 1995
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, nectrotizing 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.

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 preceeding 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011362

Sponsors and Collaborators
Investigators
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
  More Information

Additional Information:
Publications:
Study ID Numbers: NICHD-1010
Study First Received: February 15, 2001
Last Updated: February 21, 2007
ClinicalTrials.gov Identifier: NCT00011362     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Dexamethasone
Glucocorticoids
Infant, premature
Infant, very-low-birth-weight
Newborn, disease
Respiratory distress syndrome
Steroids

Study placed in the following topic categories:
Anti-Inflammatory Agents
Birth Weight
Dexamethasone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Respiratory Distress Syndrome, Adult
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Acute Respiratory Distress Syndrome
Antiemetics
Hormones
Glucocorticoids
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases
Peripheral Nervous System Agents
Dexamethasone acetate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Respiratory Distress Syndrome, Adult
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Body Weight
Signs and Symptoms
Pathologic Processes
Respiratory Insufficiency
Respiratory Tract Diseases
Syndrome
Therapeutic Uses
Dexamethasone acetate
Birth Weight
Disease
Antineoplastic Agents, Hormonal
Respiration Disorders
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009