Clinical trial NCT04757012: Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM)
Official title: Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Newborn
Keywords: Preterm newborn
Maternal voice reccording
NIPE
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 32
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* hospitalised premature newborn in Port-Royal NICU
* age between 3 and 6 daysof life
* gestational age between 27+0 and 31+6 weeks
* hospitalisation in one bed room
* parental consents
* beneficiaries social security scheme

Exclusion Criteria

* occurrence of one or more non-inclusion criteria
* Non-inclusion Criteria:
* Chromosomal abnormality, severe congenital malformation
* Toxic substance consumption during pregnancy
* Sedative medication in progress, High frequencies ventilation in progress
* Neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions
* Severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate)
* Participation to a other intervention research

Primary outcomes:
measure: Heart rate variability / NIPE Index
timeFrame: 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))
Secondary outcomes:
measure: Number of desaturation events
timeFrame: 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: Number of apnoeic events
timeFrame: 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: Number of bradycardia events
timeFrame: 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: Evaluate the benefits for the nurses
timeFrame: To be completed after each use of calinange ether on day 2, 4 and 6
measure: Evaluate the benefits for the mother
timeFrame: At day 7, after the end of intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital
Study officials:
affiliation: Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.
name: Juliana PATKAI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.