Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182312
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2005-09-13
Brief Title:
Caffeine for Apnea of Prematurity CAP
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants
Status:
COMPLETED
Status Verified Date:
2016-09
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:
None
Brief Summary:
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth Approximately 30-40 of these high-risk infants either die or survive with lasting disabilities The aim of this research is to reduce this heavy burden of illness A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months corrected for prematurity
Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants However there is a striking lack of evidence for the long-term efficacy and safety of this therapy Methylxanthines block a naturally occurring substance called adenosine which protects the brain during episodes of oxygen deficiency Such episodes are common in infants who are treated with methylxanthines It is possible that methylxanthines may worsen the damage caused by lack of oxygen Therefore this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants
Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants However there is a striking lack of evidence for the long-term efficacy and safety of this therapy Methylxanthines block a naturally occurring substance called adenosine which protects the brain during episodes of oxygen deficiency Such episodes are common in infants who are treated with methylxanthines It is possible that methylxanthines may worsen the damage caused by lack of oxygen Therefore this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants
Detailed Description:
None
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 |
|---|---|---|---|
| MOP-102601 | OTHER_GRANT | CIHR | None |
| ISRCTN44364365 | REGISTRY | None | None |
| MCT-13288 | OTHER_GRANT | None | None |