Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005777
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2000-06-01
Brief Title:
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants SAVE
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was halted because of unanticipated nonrespiratory adverse events related to dexamethasone therapy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
Brief Summary:
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 PCO2 target 52 mm Hg or routine ventilation PCO2 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
Detailed Description:
Chronic lung disease CLD also known as bronchopulmonary dysplasia BPD in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency
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 PCO2 target 52 mm Hg or routine ventilation PCO2 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
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 PCO2 target 52 mm Hg or routine ventilation PCO2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR001032 | NIH | None | httpsreporternihgovquickSearchM01RR001032 |
| U10HD034216 | NIH | None | None |
| U10HD034167 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U01HD036790 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR000070 | NIH | None | None |