Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 10:51 AM
Study NCT ID:
NCT01783561
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Sponsor:
Sharp HealthCare
Organization:
Study Overview
Official Title:
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Status:
COMPLETED
Status Verified Date:
2018-11
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:
EARLYCAFFEINE
Brief Summary:
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.
Detailed Description:
This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.
Study Oversight
Has Oversight DMC:
True
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?: