Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-03 @ 4:06 AM
Study NCT ID:
NCT02700893
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Sponsor:
Centre Hospitalier Intercommunal Creteil
Organization:
Study Overview
Official Title:
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome:
* Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication).
* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
Primary outcome:
* Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication).
* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
Detailed Description:
None
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?: