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Dexamethasone Therapy in VLBW Infants at Risk of CLD

Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Bronchopulmonary Dysplasia

Intervention: Dexamethasone Early (Drug); Dexamethasone Late (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Lu-Ann Papile, MD, Principal Investigator, Affiliation: University of New Mexico
Jon E. Tyson, MD MPH, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center
Barbara J. Stoll, MD, Principal Investigator, Affiliation: Emory University
Edward F. Donovan, MD, Principal Investigator, Affiliation: Cincinnati Children's Medical Center
Charles R. Bauer, MD, Principal Investigator, Affiliation: University of Miami
Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee Health Science Center
James A. Lemons, MD, Principal Investigator, Affiliation: Indiana University School of Medicine
Avroy A. Fanaroff, MD, Principal Investigator, Affiliation: Rainbow Babies & Children's Hospital, Case Western Reserve University
David K. Stevenson, MD, Principal Investigator, Affiliation: Stanford University
Seetha Shankaran, MD, Principal Investigator, Affiliation: Wayne State University
William Oh, MD, Principal Investigator, Affiliation: Women & Infants' Hospital, Brown University
Richard A. Ehrenkranz, MD, Principal Investigator, Affiliation: Yale University

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.

Clinical Details

Official title: Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Duration of assisted ventilation

Duration of supplemental oxygen therapy

Duration of hospital stay

Incidence of chronic lung disease

Morbidity and mortality from respiratory causes during the first year

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.

Eligibility

Minimum age: N/A. Maximum age: 15 Days. Gender(s): Both.

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

Locations and Contacts

Stanford University, Palo Alto, California 94304, United States

Yale University, New Haven, Connecticut 06504, United States

George Washington University, Washington, District of Columbia 20052, United States

University of Miami, Miami, Florida 33136, United States

Emory University, Atlanta, Georgia 30303, United States

Indiana University, Indianapolis, Indiana 46202, United States

Wayne State University, Detroit, Michigan 48201, United States

University of New Mexico, Albuquerque, New Mexico 87131, United States

Cincinnati Children's Medical Center, Cincinnati, Ohio 45267, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States

Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States

University of Tennessee, Memphis, Tennessee 38163, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States

Additional Information

Click here for more information on the NICHD Neonatal Research Network.

Click here for information on NICHD clinical trials.

Click here for the Cochrane neonatal review, "Postnatal corticosteroids for prevention of chronic lung diseasein the preterm infant: early treatment."

Starting date: September 1992
Last updated: June 3, 2015

Page last updated: August 23, 2015

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