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Home > "M" Clinical Trials Conditions > Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)  Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
For Condition: Respiratory Distress Syndrome,Bronchopulmonary Dysplasia,Infant, Premature, Diseases
Status: Terminated
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Preterm birth is a common cause of neonatal morbidity and mortality, including chronic lung disease. Extremely premature newborns who required oxygen and a ventilator for lung disease were randomized to a low tapering dose of corticosteroids vs salt water AND minimal mechanical breathing support vs routine mechanical breathing support for 10 days to test whether either intervention would reduce the risk of death or lung problems. The infants' neurodevelopment will be evaluated at 18 to 22 months corrected age.
Details: Chronic lung disease (CLD) in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency. This multicenter clinical trial tested whether early corticosteroid therapy or minimal ventilatory management would reduce the risk of CLD or death in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants and reduce the complications of therapy. Newborn infants with birth weights of 501-1000 gm who were mechanically ventilated before 12 hrs were randomized in a 2 x 2 factorial design to receive a 10-day tapering course of stress dose of dexamethasone (initial dose 0.15 mg/kg/d) vs a placebo AND minimal ventilation (target PaCO2 greater than 52 mm Hg) vs routine ventilator management (PaCO2 goal less than 48 mm Hg). The dexamethasone intervention was masked; the ventilator therapy was unmasked. The primary outcome was death or chronic lung disease (CLD, oxygen requirement at 36 wks post-menstrual age); the secondary outcomes included reduced deaths before discharge, reduced oxygen requirement at 28 days, oxygen requirement among survivors, the additive beneficial effects of both active therapies; complications of corticosteroids; other adverse outcomes; etc. The sample size of 1200 was based on an incidence of death or CLD of 0.55 in the placebo/control; a relative reduction of 20 percent in treated groups; 90 percent power; and a two-tailed Type I error of 0.05. The sample size was increased to allow assessment of impact on cerebral palsy. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. Neurodevelopment will be assessed by a masked, certified examiners at 18-22 months postmenstrual age.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /10 Days
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Greater than 12 hrs of age and less than 10 days chronologic age - 501-1000 gm - Intubated and mechanically ventilated before 12 hrs - Indwelling vascular catheter - Infants 751-100 gm must be receiving FiO2 greater than 0.30 and have received at least 1 dose of surfactant at randomization - Parental consent Exclusion Criteria: - Major congenital anomaly - Symptomatic non-bacterial infection - Permanent neuromuscular conditions that affect respiration - Terminal illness (defined as pH values less than 6.8 for more than 2 hours or persistent bradycardia associated with hypoxia for more than 2 hours) - Use of postnatal corticosteroids
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WaldemarCarlo, Principal Investigator, University of Alabama, Birmingham
Additional Information:
Study ID Numbers: NICHD-1001; U10 HD34167,U10 HD27904,U10 HD21385,U10 HD21373,M01 RR08084,M01 RR00997,M01 RR01032,U10 HD34216,U10 HD27880,M01 RR00070,U10 HD27871,U10 HD21415,M01 RR06022,U10 HD21397,M01 RR00750,U10 HD27851,U01 HD36790,U10 HD27881,U10 HD27853
Study Start Date: February 1998
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005777
Other Bronchopulmonary Dysplasia Studies:
1. Farmwork & Preterm Low Birthweight Among Hispanic Women
2. Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
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Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
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