Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011362
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2001-02-15
Brief Title:
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease CLD
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dexamethasone
Brief Summary:
Infants who are on breathing support are often treated with steroids dexamethasone however the best timing of therapy is not known This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants
Detailed Description:
Ventilator-dependent premature infants are often treated with dexamethasone However the optimal timing of therapy is unknown We compared the benefits and hazards of initiating dexamethasone therapy at two weeks of age and at four weeks of age in 371 ventilator-dependent very-low-birth-weight infants 501 to 1500 grams who had respiratory-index scores mean airway pressure x the fraction of inspired oxygen of greater than or equal 24 at two weeks of age The primary outcome was the number of days from randomization to extubation not requiring reintubation extubation score or death The secondary outcomes were death before discharge from the hospital the duration of assisted ventilation supplementary oxygen therapy and hospital stay the incidence of chronic lung disease defined as the need for supplemental oxygen at 36 weeks postconceptional age by best obstetrical estimate and rates of morbidity and mortality from respiratory causes during the first year Additional secondary endpoints were hyperglycemia hypertension growth bacteremia necrotizing enterocolitis and upper GI bleeding
The sample size of 370 was based on a 060 probability that the extubation score of late treatment was greater than early treatment a 5 two-sided type 1 error 85 power and 10 treatment noncompliance
Infants were randomized to either receive dexamethasone for two weeks followed by saline placebo for two weeks or saline placebo for two weeks followed by either dexamethasone or additional placebo for two weeks if they still met entry criteria Dexamethasone was given at a dose of 025 mg per kilogram of body weight twice daily intravenously or orally for five days and the dose then tapered
The median time to ventilator independence was 36 days in the dexamethasone-placebo group and 37 days in the placebo-dexamethasone group The incidences of chronic lung disease defined as the need for oxygen supplementation at 36 weeks postconceptional age were 66 percent and 67 percent respectively Dexamethasone was associated with an increased incidence of nosocomial bacteremia relative risk 15 95 percent confidence interval 11 to 21 and hyperglycemia relative risk 19 95 percent confidence interval 12 to 30 in the dexamethasone-placebo group elevated blood pressure relative risk 29 95 percent confidence interval 12 to 69 in the placebo-dexamethasone group and diminished weight gain and head growth P less than 0001 in both groups Treatment of ventilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four weeks of age
The sample size of 370 was based on a 060 probability that the extubation score of late treatment was greater than early treatment a 5 two-sided type 1 error 85 power and 10 treatment noncompliance
Infants were randomized to either receive dexamethasone for two weeks followed by saline placebo for two weeks or saline placebo for two weeks followed by either dexamethasone or additional placebo for two weeks if they still met entry criteria Dexamethasone was given at a dose of 025 mg per kilogram of body weight twice daily intravenously or orally for five days and the dose then tapered
The median time to ventilator independence was 36 days in the dexamethasone-placebo group and 37 days in the placebo-dexamethasone group The incidences of chronic lung disease defined as the need for oxygen supplementation at 36 weeks postconceptional age were 66 percent and 67 percent respectively Dexamethasone was associated with an increased incidence of nosocomial bacteremia relative risk 15 95 percent confidence interval 11 to 21 and hyperglycemia relative risk 19 95 percent confidence interval 12 to 30 in the dexamethasone-placebo group elevated blood pressure relative risk 29 95 percent confidence interval 12 to 69 in the placebo-dexamethasone group and diminished weight gain and head growth P less than 0001 in both groups Treatment of ventilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four weeks of 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 |
|---|---|---|---|
| U10HD027881 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U01HD019897 | NIH | None | None |
| U10HD021415 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| M01RR000997 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR006022 | NIH | None | httpsreporternihgovquickSearchM01RR006022 |