Dexamethasone Therapy in VLBW Infants at Risk of CLD (Dexamethasone)
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| ClinicalTrials.gov Identifier: NCT00011362 |
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Recruitment Status :
Completed
First Posted : February 19, 2001
Last Update Posted : March 22, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia | Drug: Dexamethasone Early Drug: Dexamethasone Late | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 371 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD) |
| Study Start Date : | September 1992 |
| Actual Primary Completion Date : | January 1994 |
| Actual Study Completion Date : | April 1994 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Dexamethasone
Dexamethasone
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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 |
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Placebo Comparator: Placebo
Saline
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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 |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 13 Days to 15 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011362
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| 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 | |
| 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 |
Publications of Results:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Dexamethasone |
Glucocorticoids Respiratory Distress Syndrome Respiratory insufficiency Steroids |
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Bronchopulmonary Dysplasia Birth Weight Body Weight Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Dexamethasone Dexamethasone acetate BB 1101 Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |