Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757012
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2021-01-24
Brief Title:
Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn CALIPREM
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
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:
CALIPREM
Brief Summary:
The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns For that we use of a specific neonatal device Calinange able to record maternal voice and heartbeats and to restore it with a sound level control We hypothesize an improvement of the well being of the newborn under Calinange exposition
Detailed Description:
Immediately after birth preterm newborns are immersed in a hostile environment of intensive care unit with light sound and painful stimulations Previously exposure to maternal voice has demonstrated improvement on infants statements reduction of bradycardia desaturation events improvement of tolerance feeding and sleep Unfortunatly in most of the N ICU in France the mothers presence attendance time is reduced because of the absence of accommodation structure The use of a specific neonatal device able to daily record maternal voice and hearbeats and to restore it when mother is gone could improve the environment and promote the well-being of the newborn
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2020-A01369-30 | OTHER | ID-RCB Number | None |