Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
NCT ID: NCT00005777
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
220 participants
INTERVENTIONAL
1998-02-28
2002-09-30
Brief Summary
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Detailed Description
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This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge.
The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants.
Neurodevelopment was assessed at 18-22 months postmenstrual age.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Minimal ventilation with Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and early stress dose dexamethasone therapy
Minimal mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target (\>52 mm Hg)
Dexamethasone
Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
Minimal Ventilation without Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and no dexamethasone therapy
Minimal mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target (\>52 mm Hg)
Placebo
The infants in the placebo groups received equal volumes of saline.
Routine ventilation with Dexamethasone
Routine mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target \<48 mm Hg)
Dexamethasone
Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
Routine ventilation without Dexamethasone
Routine mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target \<48 mm Hg)
Placebo
The infants in the placebo groups received equal volumes of saline.
Interventions
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Minimal mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target (\>52 mm Hg)
Routine mechanical ventilation management
Partial pressure of carbon dioxide (PCO2) target \<48 mm Hg)
Dexamethasone
Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
Placebo
The infants in the placebo groups received equal volumes of saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Minutes
10 Days
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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University of Alabama - Birmingham
Principal Investigators
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Waldemar A. Carlo, MD
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Ann R. Stark, MD
Role: STUDY_DIRECTOR
Brigham and Women's Hospital
William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital
Avroy A. Fanaroff, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies & Children's Hospital
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Charles R. Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Lu-Ann Papile, MD
Role: STUDY_DIRECTOR
University of New Mexico
David K. Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Sheldon B. Korones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Jon E. Tyson, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
W. Kenneth Poole, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
RTI International
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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Carlo WA, Stark AR, Wright LL, Tyson JE, Papile LA, Shankaran S, Donovan EF, Oh W, Bauer CR, Saha S, Poole WK, Stoll B. Minimal ventilation to prevent bronchopulmonary dysplasia in extremely-low-birth-weight infants. J Pediatr. 2002 Sep;141(3):370-4. doi: 10.1067/mpd.2002.127507.
Stark AR, Carlo WA, Tyson JE, Papile LA, Wright LL, Shankaran S, Donovan EF, Oh W, Bauer CR, Saha S, Poole WK, Stoll BJ; National Institute of Child Health and Human Development Neonatal Research Network. Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 2001 Jan 11;344(2):95-101. doi: 10.1056/NEJM200101113440203.
Related Links
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NICHD Neonatal Research Network
Other Identifiers
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NICHD-NRN-0018
Identifier Type: -
Identifier Source: org_study_id
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