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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04757012
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Juliana PATKAI, MD
Phone 033 1 58413645
Email juliana.patkai@aphp.fr
Status Recruiting
Phase N/A
Start date April 19, 2022
Completion date April 2023

See also
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Terminated NCT02885051 - Evaluation of Pain in Preterm Newborn N/A
Recruiting NCT06281093 - Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System N/A