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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01369-30 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calinage exposition | Experimental | exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6 |
|
| no exposition | No Intervention | No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calinange | Device | calinange |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability / NIPE Index | Recorded heart rate | Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of desaturation events | Change in desaturation events before and after intervention | Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) |
| Number of apnoeic events |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Juliana PATKAI, MD | Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23890732 | Background | Alexandre C, De Jonckheere J, Rakza T, Mur S, Carette D, Logier R, Jeanne M, Storme L. [Impact of cocooning and maternal voice on the autonomic nervous system activity in the premature newborn infant]. Arch Pediatr. 2013 Sep;20(9):963-8. doi: 10.1016/j.arcped.2013.06.006. Epub 2013 Jul 23. French. | |
| 23848529 | Background |
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Change in apneic events before and after intervention |
| Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) |
| Number of bradycardia events | Change in bradycardia events before and after intervention | Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) |
| Evaluate the benefits for the nurses | Evaluation questionnaire | To be completed after each use of calinange ether on day 2, 4 and 6 |
| Evaluate the benefits for the mother | Satisfaction questionnaire | At day 7, after the end of intervention |
| Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8. |
| 31335378 | Background | Williamson S, McGrath JM. What Are the Effects of the Maternal Voice on Preterm Infants in the NICU? Adv Neonatal Care. 2019 Aug;19(4):294-310. doi: 10.1097/ANC.0000000000000578. |
| 29535067 | Background | Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10. |