Trial Search Results

Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

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 infants' neurodevelopment was evaluated at 18-22 months corrected age.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Center for Research Resources (NCRR)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Minimal mechanical ventilation management
  • Procedure: Routine mechanical ventilation management
  • Drug: Dexamethasone
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 10 Days

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting