Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2020-09-04
Brief Title:
The Budesonide in Babies BiB Trial
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Randomized Controlled Trial of Budesonide Surfactant Versus Surfactant Alone in Extremely Preterm Infants The Budesonide in Babies BiB Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
BiB
Brief Summary:
This is a Phase 3 randomized masked active-controlled multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant as compared to surfactant alone will reduce the incidence of physiologic bronchopulmonary dysplasia BPD or death by 36 weeks post-menstrual age in extremely preterm infants
Detailed Description:
From a study of 9575 extremely preterm 22-28 weeks gestational age and 401-1500g birth weight infants born between 2003 and 2007 and enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD Neonatal Research Network NRN it is anticipated that 93 of extremely preterm infants will develop respiratory distress syndrome 68 will develop bronchopulmonary dysplasia BPD 16 will develop severe intraventricular hemorrhage and 36 will develop late-onset sepsis PMID 20732945 Furthermore in 2014 20 of the infants enrolled in the NRN Generic Database GDB died 8 by less than 12 hours 12 between 12 hours and 120 days and 1 after 120 days and 47 of infants who survived to 36 weeks post-menstrual age PMA developed physiologic BPD NRN GDB data BPD is therefore one of the most common morbidities in extremely preterm infants Death is a competing outcome for BPD as infants who die before ascertainment of BPD at 36 weeks PMA cannot be diagnosed with BPD even though they may have been at the highest risk As children get older BPD has been shown to be associated with worse cognitive outcomes in school age and with abnormal pulmonary function in adolescence and adulthood PMID 14595077 15499947 2247118
Recent randomized trials have indicated a lower incidence of BPDdeath with the use of a combination of budesonide with surfactant budesonide surfactant compared to surfactant alone when administered soon after birth Therefore after obtaining informed consent and confirming eligibility for the trial infants are randomized in a 11 allocation ratio to either the budesonide surfactant arm or the surfactant alone arm within 48 hours of birth
Recent randomized trials have indicated a lower incidence of BPDdeath with the use of a combination of budesonide with surfactant budesonide surfactant compared to surfactant alone when administered soon after birth Therefore after obtaining informed consent and confirming eligibility for the trial infants are randomized in a 11 allocation ratio to either the budesonide surfactant arm or the surfactant alone arm within 48 hours of birth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| UG1HD112100 | NIH | None | httpsreporternihgovquickSearchUG1HD112100 |
| UG1HD034216 | NIH | None | None |
| UG1HD027904 | NIH | None | None |
| UG1HD021364 | NIH | None | None |
| UG1HD027853 | NIH | None | None |
| UG1HD040689 | NIH | None | None |
| UG1HD040492 | NIH | None | None |
| UG1HD027851 | NIH | None | None |
| UG1HD087229 | NIH | None | None |
| UG1HD053109 | NIH | None | None |
| UG1HD068278 | NIH | None | None |
| UG1HD068244 | NIH | None | None |
| UG1HD068263 | NIH | None | None |
| UG1HD027880 | NIH | None | None |
| UG1HD053089 | NIH | None | None |
| UG1HD087226 | NIH | None | None |
| U10HD036790 | NIH | None | None |
| UG1HD112079 | NIH | None | None |
| UG1HD112097 | NIH | None | None |