Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
Public ClinicalTrials.gov record NCT00005777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely-Low-Birth-Weight Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00005777
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Interventions
- Minimal mechanical ventilation management Procedure
- Routine mechanical ventilation management Procedure
- Dexamethasone Drug
- Placebo Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 5 Minutes to 10 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1998 (Type not available)
- Primary completion
- Sep 1998 (Actual)
- Completion
- Sep 2002 (Actual)
- Last update posted
- Jun 8, 2015
1998 – 2002
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Yale University | New Haven | Connecticut | 06504 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Tennessee | Memphis | Tennessee | 38163 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00005777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2015 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00005777 live on ClinicalTrials.gov.